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Dr. Peter McCullough on the suppression of Covid therapeutics -
>>> "Spike protein is very dangerous, it's cytotoxic (Robert Malone, Steve Kirsch, Bret Weinstein)" <<< -
LYRA, ready to move into Phase III with Significant Efficacy (p=0.03) in a $50 B market, 80 million patients in China alone
https://investors.lyratherapeutics.com/news-releases/news-release-details/lyra-therapeutics-announces-positive-outcome-end-phase-2-meeting
Analyst: William Blair Focus Conference
https://wsw.com/webcast/blair59/lyra/1950784
$IBIO Ibio Inc., formerly known as iBioPharma Inc., is a biopharmaceutical company that primarily focuses on developing vaccines and therapeutic proteins based upon its plant-based iBioLaunch platform technology. The Company's hydroponically grown green plants can be used for the development and manufacture of proteins applicable to a range of disease agents, such as influenza, sleeping sickness, anthrax, plague, human papillomavirus and veterinary influenza applications. IBio, Inc. is headquartered in Newark, Delaware. https://www.barchart.com/stocks/quotes/IBIO/profile
#Covid19 Vaccine Maker $IBIO Top Mutual Fund Holders
Holder Shares Date Reported % Out Value
Vanguard Total Stock Market Index Fund 6,182,400 Mar 30, 2021 2.84% 9,520,896
iShares Russell 2000 ETF 4,868,109 May 30, 2021 2.23% 7,058,758
Vanguard Extended Market Index Fund 2,725,700 Mar 30, 2021 1.25% 4,197,578
Fidelity Small Cap Index Fund 1,655,392 Apr 29, 2021 0.76% 2,267,887
iShares Russell 2000 Growth ETF 1,586,587 May 30, 2021 0.73% 2,300,551
Fidelity Extended Market Index Fund 1,144,666 May 30, 2021 0.53% 1,659,765
iShares Micro Cap ETF 574,587 May 30, 2021 0.26% 833,151
Schwab Capital Trust-Small Cap Index Fund 456,189 Apr 29, 2021 0.21% 624,978
iShares Core S&P Total U.S. Stock Market ETF 429,442 May 30, 2021 0.20% 622,690
TIAA-CREF Funds-Small-Cap Blend Index Fund 370,538 Apr 29, 2021 0.17% 507,637
https://finance.yahoo.com/quote/IBIO/holders?p=IBIO
Blade, Just curious if you are adding to CRIS after the selloff? Looks like it has stabilized and found support at the 200 MA.
Also, any thoughts on CCXI's chances? I got in briefly to get the recent bounce (small position), but am leery of being long going into the PDUFA date.
Thanks for any insights :o)
MGTA upgraded
Magenta upgraded to buy on stem cell transplant potential
BTIG has upgraded Magenta Therapeutics (NASDAQ:MGTA) from under review to buy and a price target of $20 (~43% upside).
Analyst Yun Zhong says that hematopoietic stem cell transplant ("HCST") market is growing with a strong unmet medical need.
Zhong notes that the number of HCST procedures doubled in the past 10 years, and more than 50,000 people per year have the procedure. However, many more could benefit but are not eligible.
Bladerunner
KZIA in new clinical collaboration with Cornell Universaity for glioblastoma
Kazia Enters Clinical Collaboration With Cornell University for Phase II Clinical Study Using Paxalisib in Combination With Ketogenic Diet for Glioblastoma
BY PR Newswire
— 10:00 AM ET 06/15/2021
SYDNEY, June 15, 2021 /PRNewswire/ -- Kazia Therapeutics Limited ( KZIA
) , an oncology-focused drug development company, is pleased to announce that it has entered a collaboration with the Joan & Sanford I Weill Medical College of Cornell University in the United States, to launch a phase II clinical study investigating the use of Kazia's investigational new drug, paxalisib, in combination with ketogenesis, for glioblastoma.
Key Points
• Research by Professor Lew Cantley, who discovered the PI3K pathway, suggests that ketogenesis may enhance the activity of PI3K inhibitors in glioblastoma, with impressive preclinical data previously published in Nature
•
• Ketogenesis represents an alternative biochemical mechanism in which the body is fueled by fats and proteins rather than by glucose; it occurs in states such as starvation, and also in response to a 'ketogenic diet'
• Data from this study has the potential to significantly enhance the activity of paxalisib in glioblastoma, and to minimize certain side effects, including hyperglycemia (high blood sugar)
•
• Dr Howard Fine, founding Director of the Brain Tumor Center at New York-Presbyterian Weill Cornell Medical Center, will serve as Principal Investigator; Professor Cantley will be a scientific advisor to the study
• Kazia will provide support including study drug and a financial grant
•
Dr Fine, Principal Investigator to the study, commented, "glioblastoma remains an immensely challenging disease, and we need the most potent array of tools at our disposal in order to treat it. My lab has extensive experience of translational research in this area, and I am excited to explore the potential for a brain-penetrant PI3K inhibitor in combination with ketogenesis."
Professor Cantley, who is a scientific advisor to the study, added, "the interplay between the PI3K pathway, insulin signaling, and tumor growth has been a focus of scientific interest for some time now. Our research clearly shows the synergistic benefits of PI3K inhibition and ketosis in animal models of glioblastoma. This is an important project, designed to verify these laboratory findings in the human setting."
Ketogenesis and Glioblastoma
Cells in the human body generally rely on glucose as 'fuel' for their energy requirements. However, when glucose is not readily available, cells can metabolise fats and proteins to provide energy. The fats and proteins are broken down to an intermediate form known as ketones, and so this biochemical pathway is referred to as 'ketogenesis'.
Unlike healthy cells, most tumour cells are poorly able to metabolise ketones, and so depend on glucose for their energy needs. Consequently, many researchers have experimented with 'ketogenic diets' as a potential treatment for cancer.[1]
In addition, scientists in Professor Cantley's lab have shown that insulin has the potential to counteract the anti-tumor effects of PI3K inhibitors.[2] Insulin is a hormone produced by the body in response to high levels of glucose. When the body is in a state of ketosis, glucose is absent, and so insulin falls to very low levels.
For these reasons, there is a sound rationale to explore a combination of ketogenic diet and paxalisib in glioblastoma. In this study, patients will also receive metformin, a common anti-diabetic drug, which will help to further lower insulin levels.
[1] A Kapelner & M Vorsanger (2015). Medical Hypotheses. 84(3):162-168
[2] B Hopkins et al. (2018). Nature. 560:499-503
Clinical Trial Design
This study will comprise two arms. The first will contain patients with newly diagnosed glioblastoma who have unmethylated MGMT promotor status. These patients are essentially resistant to temozolomide, the existing standard-of-care therapy. The second arm will contain patients with recurrent disease, who have progressed after taking standard-of-care therapy.
In each arm, paxalisib will be combined with metformin and with a ketogenic diet. The diet will be overseen by expert clinical dieticians to ensure that it is scientifically appropriate and that patients are compliant.
An initial cohort of approximately sixteen patients will be recruited to each arm. If there are signals of activity in a given arm, that arm will be expanded to approximately thirty patients. The primary endpoint will be progression-free survival at six months (PFS6). In addition to efficacy and safety, the study will examine a range of metabolic and pharmacodynamic biomarkers to help inform future research and clinical practice. The study is expected to take approximately two years to complete.
Dr Howard Fine will serve as Principal Investigator to the study. Dr Fine is the founding Director of the Brain Tumor Center at New York-Presbyterian Weill Cornell Medical Center, and Associate Director for Translational Research at the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. He is an internationally recognized leader in the field of neuro-oncology, with more than 30 years of experience in both laboratory and clinical research as well as in the care of patients with brain tumors. Dr Fine has built large multidisciplinary brain tumor programs at top academic institutions such as the Dana Farber Cancer Institute / Harvard Medical School and the National Institutes of Health, has cared for nearly 20,000 patients with brain and spinal cord tumors in his career, has conducted over 100 clinical trials, published over 250 papers and book chapters on brain tumors, and for over two decades has run a continuously operating translational genetic / molecular laboratory devoted to a better understanding of, and better therapies for, brain tumors.
Weill Cornell Medical Center
The Joan & Sanford I. Weill Medical College of Cornell University, known generally as Weill Cornell Medicine, and based in New York, NY, is the medical school of Cornell University, and is one of the leading medical research centers in the United States. Its notable alumni include Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Disease.
Paxalisib Clinical Program
The initiation of this trial in glioblastoma brings the number of ongoing clinical studies of paxalisib in brain cancer to nine.
Sponsor Phase Indication Registration
Kazia Therapeutics ( KZIA
) II Glioblastoma NCT03522298
Global Coalition for
Adaptive Research II / III Glioblastoma NCT03970447
Weill Cornell Cancer
Center II Glioblastoma
(with ketogenic diet + metformin) TBD
Alliance for Clinical Trials
in Oncology II Brain metastases NCT03994796
Dana-Farber Cancer
Institute II Breast cancer brain metastases
(with Herceptin) NCT03765983
Dana-Farber Cancer
Institute II Primary CNS lymphoma NCT04906096
Pacific Pediatric Neuro-
Oncology Consortium N/A DIPG & DMGs TBD
St Jude Children's
Research Hospital I DIPG (childhood brain cancer) NCT03696355
Memorial Sloan
Kettering Cancer Center I Brain metastases
(with radiotherapy) NCT04192981
Next Steps
Recruitment to this study is expected to commence by the end of CY2021, subject to approval by Institutional Review Boards, FDA, and other authorities.
About Kazia Therapeutics Limited ( KZIA
) is an oncology-focused drug development company, based in Sydney, Australia.
Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021. Eight additional studies are active in various forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020.
Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided compelling evidence of synergy with immuno-oncology agents. A phase I study is expected to begin in CY2021.
For more information, please visit www.kaziatherapeutics.com or follow us on Twitter @KaziaTx.
This document was authorized for release to the ASX by James Garner, Chief Executive Officer, Managing Director.
View original content to download multimedia:http://www.prnewswire.com/news-releases/kazia-enters-clinical-collaboration-with-cornell-university-for-phase-ii-clinical-study-using-paxalisib-in-combination-with-ketogenic-diet-for-glioblastoma-301312028.html
SOURCE Kazia Therapeutics Limited ( KZIA )
Bladerunner
$MJNA The First to Deliver Cannabis Brands Across U.S. State Lines and International Borders, Making Cannabidiol Available Across 50 States, and in Dozens of Countries
CV Sciences, Inc. $CVSI http://www.cvsciences.com
$MJNA First with a License to Commercialize the U.S. National Institutes of Health Patent “Cannabinoids as Antioxidants and Neuroprotectants.”
Medical Marijuana, Inc. subsidiary Kannalife™ Sciences holds the first two licenses awarded to develop and commercialize drug treatments under the U.S. government’s only cannabinoid patent. Kannalife™ Sciences is a phyto-medical company specializing in the research and development of cannabinoid based pharmaceuticals
https://www.medicalmarijuanainc.com/company-of-firsts/the-first-to-license-to-commercialize-the-us-national-institues-of-health-patent/
MGTA reports positive results in multiple myeloma at ASCO. Stock down. I don't know why. Results look good to me. Comments?
Magenta Therapeutics Announces Additional Preliminary Positive Results from Ongoing Phase 2 Clinical Trial of MGTA-145 and Plerixafor in Patients with Multiple Myeloma at the American Society of Clinical Oncology (ASCO) Annual Meeting
Fri, June 4, 2021, 6:00 AM
MGTA
-2.83%
– Preliminary results from the initial cohort of 10 patients were previously reported on May 12 in a published abstract at the European Hematology Association (EHA) Congress –
– The cumulative data as of the data cut-off date show that all patients (15/15) treated with MGTA-145 and plerixafor met the primary endpoint of sufficient stem cell mobilization and collection for transplant –
– All patients (12/12) transplanted with MGTA-145 and plerixafor to date have successfully engrafted; six patients have completed day-100 follow up with demonstrated durable engraftment –
– These results will also be presented at the EHA Congress, June 9-17, 2021 –
Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today announced additional positive results from a Phase 2 clinical trial of MGTA-145 and plerixafor in patients with multiple myeloma at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually June 4-8, 2021.
"We are very pleased to see continued favorable results for MGTA-145 and plerixafor for stem cell mobilization and collection in patients with multiple myeloma," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "These results build on those previously disclosed from this study and the Phase 1 trials to further demonstrate MGTA-145 and plerixafor’s potential as a rapid, reliable, well-tolerated approach to stem cell mobilization and collection, which has positive implications for patients and donors."
Additional Results – MGTA-145 Multiple Myeloma Phase 2 Clinical Trial
The investigator-initiated, 25-patient Phase 2 clinical trial is designed to evaluate the ability of MGTA-145, in combination with plerixafor, to mobilize and collect hematopoietic stem cells for autologous stem cell transplant in patients with multiple myeloma. This study is led by Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy at Stanford University School of Medicine.
Previously reported results from this trial were announced on May 12, 2021, in a published abstract for the European Hematology Association (EHA) Congress and provided preliminary data from the initial cohort of 10 patients.
Summary of cumulative results through data cut-off date:
All patients (15/15) have met the primary endpoint of mobilization and collection of 2 million CD34+ stem cells per kg in up to two days. Twelve of 15 patients achieved the primary endpoint in a single day of dosing and collection.
The median number of total CD34+ stem cells collected on day 1 and 2 (if needed) was 6.3 million per kg. Current standard of care with G-CSF-based regimens require a minimum of five days of dosing to initiate stem cell collection.
All transplanted patients to date (12/12) successfully engrafted, with median recovery of neutrophils after 12.5 days and platelets after 18 days, which are within transplant expectations in multiple myeloma.
Six patients have completed day-100 follow up, with demonstrated durable engraftment indicative of a successful transplant.
The collected CD34+ stem cells contain a high percentage (40%) of CD34+CD90+, a stem cell population associated with multi-lineage, long-term engraftment, an amount substantially greater than historically observed with G-CSF-mobilized cells.
The regimen of MGTA-145 and plerixafor was well tolerated. Acute, transient, MGTA-145-related grade 1 bone or musculoskeletal pain was observed in 40% of patients shortly after MGTA-145 infusion, resolving within 10 minutes for all patients, and none required pain medication or other intervention.
As indicated previously, this trial has broad and clinically representative inclusion criteria and includes patients that represent the general transplant-eligible population of patients with multiple myeloma. Patients enrolled in this trial included those patients with risk factors that could impact stem cell mobilization and collection, such as myeloma-directed therapies that are known to impact stem cell collection, previous malignancy treated with chemotherapy and/or radiation, and other co-morbid conditions. Mobilization agents may be less effective in patients with multiple risk factors. Final clinical data from this trial are anticipated by the end of 2021. MGTA-145 is also being evaluated for its ability to mobilize and collect stem cells from donors for allogenic transplant in patients with acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in a Phase 2 trial, and an additional Phase 2 study is planned to initiate in patients with sickle cell disease in the second half of 2021.
ASCO Poster Presentation
Title: Phase 2 Study of MGTA-145 + Plerixafor for Rapid and Reliable Hematopoietic Stem Cell (HSC) Mobilization for Autologous Stem Cell Transplant in Multiple Myeloma (Abstract #8023)
Author: Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine
Poster Session: Hematologic Malignancies – Plasma Cell Dyscrasia
Date/Time: All e-posters are now available in the ASCO Annual Meeting virtual platform
These results will also be presented as an encore at the EHA Virtual Congress, available via the conference’s virtual platform on Friday, June 11 at 3:00am EDT / 9:00am CEST.
About Magenta Therapeutics
Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.
Magenta is based in Cambridge, Mass. For more information, please visit www.magentatx.com.
Follow Magenta on Twitter: @magentatx.
Bladerunner
>>> Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19
Yahoo Finance
May 28, 2021
https://finance.yahoo.com/news/humanigen-submits-application-fda-emergency-130000674.html
Humanigen, Inc. (Nasdaq:HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced that the company submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for lenzilumab for the treatment of patients hospitalized with COVID-19. This EUA application follows positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.
"Filing for EUA in the U.S. is a critical step to making a therapeutic option available for COVID-19," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "There is a need for therapies for hospitalized patients who require supplementary oxygen. Treatments can be lifesaving; despite vaccinations, infections and significant breakthrough disease will continue. Lenzilumab, should the FDA grant authorization, can address a critical unmet need for an effective treatment. We are extremely grateful to the investigative team and volunteers in the clinical trial program, as their involvement was vital in delivering this positive Phase 3 study."
Lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of SWOV compared to placebo. Lenzilumab also improved the relative likelihood of SWOV by 92% in subjects who received both corticosteroids and remdesivir and resulted in a 3-fold improvement in the likelihood of SWOV in patients with a CRP<150 mg/L and less than 85 years of age. In these patients, a 2.2-fold improvement in the likelihood of survival was observed with lenzilumab. No serious adverse events were attributed to lenzilumab and the overall safety profile was comparable to placebo.
"We are excited and encouraged by these clinical results and are preparing to distribute lenzilumab if granted Emergency Use Authorization," said Edward P. Jordan, MBA, Chief Commercial Officer, Humanigen. "We are committed to getting lenzilumab into the hands of medical professionals for the treatment of COVID-19. It is anticipated that thousands of patients will continue to be hospitalized daily, some of whom may benefit from lenzilumab."
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen’s immediate focus is on the development of lenzilumab as a therapy for hospitalized, hypoxic COVID-19 patients. Humanigen recently announced plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma.
Humanigen is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.
<<<
>>> Why Provention Bio Stock Is Soaring Today
The FDA posted briefing documents that appear to bode well for approval of the company's lead candidate.
Motley Fool
by Keith Speights
May 25, 2021
https://www.fool.com/investing/2021/05/25/why-provention-bio-stock-is-soaring-today/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
What happened
Shares of Provention Bio (NASDAQ:PRVB) were soaring 21.6% as of 10:56 a.m. EDT on Tuesday. The big jump came after the U.S. Food and Drug Administration (FDA) released briefing documents in advance of an advisory committee meeting scheduled for May 27. This advisory committee will review Provention's Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
So what
Provention couldn't have asked for better news in the FDA's briefing documents. The agency stated that the company's TN-10 pivotal study "successfully demonstrated the treatment effect of teplizumab in delaying T1D diagnosis in at-risk relatives of T1D patients for a median time of approximately 2 years."
The FDA briefing documents also noted that there aren't any approved therapies currently for delaying the onset of T1D. Because of the medical need and "the impracticality of conducting a second long-term clinical trial," the agency appeared to encourage the advisory committee to accept Provention's TN-10 study as meeting the threshold for showing effectiveness.
Now what
The next key catalyst for the biotech stock will come in just a couple of days when the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meets to review the regulatory filing for teplizumab. Although the advisory committee could take a less favorable stance than the FDA briefing documents do, investors are betting that won't be the case.
<<<
re: MYOV
Myovant Sciences Receives Positive CHMP Opinion for RYEQO® (Relugolix Combination Tablet) for the Treatment of Women With Uterine Fibroids
Myovant Sciences, Inc.
Fri, May 21, 2021, 5:30 AM
MYOV
+5.89%
CHMP opinion recommending approval based on data from the Phase 3 LIBERTY program in women with uterine fibroids
Gedeon Richter will commercialize RYEQO for uterine fibroids, if approved, in Europe
Relugolix combination tablet for uterine fibroids is also under U.S. FDA review with a target action date of June 1, 2021
BASEL, Switzerland, May 21, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The European Commission will review the CHMP recommendation, and a final decision on the Marketing Authorization Application is expected to be available in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.
“Over 25% of women of reproductive age develop uterine fibroids. This chronic disease can cause debilitating symptoms that have a significant impact on quality of life and require long-term treatment, yet there are currently limited treatment options in Europe and many women are faced with the decision to undergo surgery to alleviate symptoms,” said Roberta Venturella, M.D., Ph.D., Associate Professor, Magna Græcia University of Catanzaro and investigator in the LIBERTY program. “The CHMP’s positive opinion further validates RYEQO’s potential to effectively address heavy menstrual bleeding and pain associated with uterine fibroids and serve as an important new treatment option for patients and physicians.”
“This positive CHMP opinion represents an important step in advancing our mission to redefine care for women living with uterine fibroids,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “We look forward to Gedeon Richter’s launch of RYEQO, if approved, as a new treatment option for uterine fibroids.”
The positive opinion recommending approval is based on safety and efficacy data from the Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies (LIBERTY 1 and LIBERTY 2), a one-year extension study, and a randomized withdrawal study assessing the safety and efficacy for up to two years of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg). Results from the LIBERTY 1 and LIBERTY 2 studies were published in the New England Journal of Medicine in February 2021.
In March 2020, Myovant and Gedeon Richter entered into an exclusive license agreement for Gedeon Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand. Under the terms of the agreement, Myovant continues to lead the global development of relugolix combination tablet while Gedeon Richter is responsible for local clinical development, manufacturing, and all commercialization for its territories.
Relugolix combination tablet for the treatment of uterine fibroids is also under review by the U.S. Food and Drug Administration, with a target action date of June 1, 2021.
About Uterine Fibroids
Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual's genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth.
Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as heavy menstrual bleeding (frequently resulting in anemia and fatigue), pain (including painful periods, abdominal pain, painful intercourse, backache), increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.
About RYEQO®
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is being evaluated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. RYEQO contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen), which may reduce the risk of bone loss, and norethindrone acetate (a progestin), which is necessary when women with a uterus (womb) take estrogen.
RYEQO is not approved for any indication in any geography.
About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. ORGOVYX™ (relugolix) was approved by the U.S. Food and Drug Administration in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix is also under regulatory review in Europe for men with advanced prostate cancer. Our lead product candidate, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg), is under regulatory review in the U.S. and Europe for women with uterine fibroids, has completed Phase 3 registration-enabling studies for women with endometriosis, and is being assessed for contraceptive efficacy in healthy women ages 18-35 years who are at risk for pregnancy. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.
Bladerunner
gfp,
re: CCXI
I looked at the briefing docs and I'm no expert in these things, but I don't see how the drug can be approved, regardless of panel decision. Maybe this is another Dendreon-type situation, but I wouldn't bet on it.
CCXI was once my largest position. I sold my last tranche at $64.50, so this was my largest gain on any stock ever. This stock secured my retirement. It was dumb luck.
Bladerunner
Blade, Any thoughts on CCXI's chances for approval? I see the FDA panel actually did recommend approval, but by a slim margin. But it sounds like an additional Phase 3 might be needed. I've never seen so many class action lawsuits filed so quickly.
Wasn't CCXI the stock that you cleaned up on in 2019-2020? A while back I remember you saying that you had sold the last of your shares, so excellent timing :o)
Looking at what happened shows how treacherous this sector can be. I'm reminded of the famous Andy Grove saying - 'Only the paranoid survive'.
Years ago Dendreon had a similar flattening, only to rise again, but then ultimately was flattened for good. The crazy world of bio..
Blade, Yes, nice move for FSTX. Those Q-1 results came out on Monday, so I guess today's move was a delayed reaction. It was a strong day for the markets and biotech in general, which helps.
It takes a lot of patience with these bio stocks. I've been trying to get into a longer term mindset. With the overall stock market so high, the tendency is to take profits quickly when they appear.
Fwiw I currently have small positions in HGEN and IPIX. The last time IPIX was this cheap I managed to get a quick double, and HGEN looks poised for a move. Keeping fingers crossed :o) Just small positions, so mainly for the fun aspect.
Any new stocks you are looking at?
FSTX reports 1st quarter results. Stock up 13%.
GlobeNewswire
F-star Therapeutics Reports First Quarter 2021 Financial Results and Provides Corporate Update
F-star Therapeutics, Inc.
Mon, May 17, 2021, 5:00 AM
FSTX
+12.48%
Company to Host Conference Call Today at 9 a.m. EDT
CAMBRIDGE, United Kingdom and CAMBRIDGE, Mass., May 17, 2021 (GLOBE NEWSWIRE) -- F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation bispecific immunotherapies to transform the lives of patients with cancer, today announces first quarter 2021 financial results and provides a corporate update.
Strengthens balance sheet with successful closing of $65 million public offering of common stock and;
Received $9.2 million in net proceeds under its "at-the-market" equity offering program
LAG-3 and PD-(L)1 co-targeting validation with LAG-3 validated in late-stage clinical trial as third checkpoint inhibitor pathway
FS118 patent protection granted in Europe expanding F-star’s extensive IP portfolio
FS222 presentation at AACR on the importance of tuning both affinity and avidity for differentiation
Nature publication on STING agonist demonstrating that SB 11285 enhances preclinical efficacy of radiation therapy
Merck KGaA, Darmstadt, Germany exercises option to bring third target into pipeline
Eliot Forster, CEO of F-star Therapeutics, Inc., said, “I’m very proud of what F-star accomplished in our first full quarter as a publicly traded company. The successful close of our public offering means we have now strengthened our financial position to ensure delivery on our future milestones. We have made excellent progress across all four clinical stage programs. We have also delivered with our partners, as noted in the recent update on our collaboration with Merck KGaA. We have added new insights into the unique properties of our platform technology, including presenting new data on FS222, our potentially best-in-class bispecific antibody targeting CD137 and PD-L1. This year will be another exciting one for F-star with clinical data expected and huge potential to provide transformational treatment options for patients with cancer.”
“We have had a great start to 2021 and are very pleased to complete our $65 million underwritten public offering,” said Darlene Deptula-Hicks, Chief Financial Officer of F-star Therapeutics. “Based on our current operating plans we believe our current cash and cash equivalents will be sufficient to meet our capital requirements into the second half of 2023.”
FIRST QUARTER 2021 AND RECENT HIGHLIGHTS
Clinical validation of LAG-3: Aligning with F-star’s promising internal data, new headline phase 3 data reported during the quarter by a global pharmaceutical company has potentially validated LAG-3 as an immuno-oncology target. Importantly for FS118, these data also confirm the necessity of co-targeting the LAG-3 and PD-1/PD-L1 pathways to achieve efficacy in patients.
FS118 European patent protection granted: The European Patent Office (EPO) granted a patent in January 2021 with claims protecting the composition of matter of F-star’s FS118 molecule giving protection until June 2037. The phase 2 proof-of-concept trial of FS118 is proceeding on plan and the Company plans to provide an update on progress in the first half of 2022.
FS222 Poster presented at the American Association for Cancer Research (AACR) Annual Meeting in 2021: F-star presented a poster at AACR 2021 entitled ‘FS222, a Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is Designed for Optimal CD137 Interactions Resulting in Potent T cell Activation Without Toxicity’. This poster and the associated data showcased the differentiation of FS222 from competitor molecules and highlighted the importance of ‘tuning’ for both the affinity and avidity of bispecific antibodies. The ongoing phase 1 clinical trial is proceeding on plan and the Company plans to provide an update on progress before the end of 2021.
SB 11285 in Nature publication: F-star published on its second-generation STING agonist, SB 11285, in the April 2021 issue of Nature Communications. The study, entitled ‘STING enhances cell death through regulation of reactive oxygen species and DNA damage’ demonstrated that systemic administration of a STING agonist in combination with radiation in a preclinical model enhances local control in Head and Neck Squamous Cell Carcinoma (HNSCC) and suggests that STING expression in the tumor is required for maximal therapeutic benefit. The Company plans to provide an update on the progress of SB 11285 in the phase 1 clinical trial in mid-2021.
Merck, KGaA, Darmstadt, Germany exercised third target option: F-star continued to deliver on the collaboration with Merck, KGaA, Darmstadt, Germany. The third option to license an F-star preclinical immuno-oncology program was exercised in the ongoing collaboration in March 2021. The companies entered into the agreement in 2019 with the first option to license. In July 2020, Merck KGaA, Darmstadt, Germany brought the second program from the collaboration into its pipeline, and has recently exercised its third option, taking over future development and commercialization of the program.
Denali Therapeutics announcement: F-star is pleased by the announcement from Denali Therapeutics that following positive preliminary data in a Phase 1/2 study, the Food and Drug Administration (FDA) has granted Fast Track designation to DNL310, which is derived from F-star's unique Fcab technology, for the treatment of patients with Hunter syndrome.
Strengthened balance sheet in 2021: In April the Company completed the sale of $9.5 million in gross proceeds through its previously announced “at-the-market” (ATM) equity offering program. In addition, in April the Company entered into and drew down $5 million under its $10 million debt facility with Horizon Technology Finance Corporation and in May raised gross proceeds of $65 million, before deductions of underwriting discounts and commissions, in a public offering.
FIRST QUARTER 2021 FINANCIAL SUMMARY
Cash and cash equivalents as of March 31, 2021 were $3.7 million, compared to $18.5 million at December 31, 2020. Based on the Company’s current operating plan, the Company believes its cash and cash equivalents at March 31, 2021, together with the net proceeds from the recent sales of common stock in the underwritten public offering and under the ATM, and funds from its debt facility will be sufficient to fund its current operating plans into the second half of 2023.
Research & Development (R&D) expenses were $7.3 million for the quarter ended March 31, 2021, compared to $3.4 million for the same quarter in 2020. The increase of $3.9 million in R&D expense was primarily related to manufacturing costs and clinical costs with Q1 being the first full quarter with four programs in the clinic.
General & Administrative (G&A) expenses were $6.4 million for the quarter ended March 31, 2021, compared to $3.2 million for the first quarter of 2020. This $3.2 million increase in G&A expense was primarily due to increased non-cash stock-based compensation expense, professional fees and insurance associated with operating as a public company and rent expense associated with building leases assumed in the share exchange.
Net loss was $9.9 million or a loss per share of $1.08 (basic and diluted), for the quarter ended March 31, 2021, compared to a net loss of $7.2 million or a loss per share of $3.92 (basic and diluted) for the quarter ended March 31, 2020.
CONFERENCE CALL AND WEBCAST
F-star will host a conference call today, May 17, 2021 beginning at 9:00 AM EDT. To join the webcast, go to website. To join by phone, participants may dial 1-833-471-0868 in the US/Canada or 1-914-987-7751 for International calls or 0800 0288438 or 0203 1070289 for the United Kingdom, at least 10 minutes prior to the start of the call.
Bladerunner
ONCT up over 13% in AH after presenting data that will get an oral presentation at ASCO
Oncternal Therapeutics Presents Updated Interim Data for TK216 in Patients with Relapsed or Refractory Ewing Sarcoma in an Oral Session at ASCO 2021
Oncternal Therapeutics
Wed, May 19, 2021, 2:30 PM
ONCT
-4.14%
Latest data from study TK216-01 remain encouraging, are consistent with previous results, and are updated over data contained in ASCO Abstract #11500 released today
Two patients who achieved a complete response (CR) remain with no evidence of disease, one for over 24 months and the other for over 14 months on study
TK216 remained generally well tolerated with a manageable safety profile
SAN DIEGO, May 19, 2021 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced updated interim clinical data from the oral presentation on its ongoing Phase 1/2 clinical trial evaluating TK216, an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, in patients with relapsed or refractory Ewing sarcoma, to be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.
Ravin Ratan, M.D., Assistant Professor, Department of Sarcoma Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, will present at the ASCO 2021 Annual Meeting Sarcoma oral session that two heavily pre-treated and metastatic Ewing sarcoma patients treated at the recommended Phase 2 dose (RP2D) of TK216 continue to demonstrate prolonged complete regression of Ewing sarcoma for greater than one and two-years on study and have tolerated ongoing treatments well with TK216 alone or in combination with vincristine.
The data will be presented at the ASCO 2021 Annual Meeting:
Abstract Title: TK216 for Relapsed/Refractory Ewing Sarcoma: Interim Phase 1/2 Results
Abstract number: 11500
Session Title: Sarcoma
Session Date and Time: June 4, 2021, from 1:30 – 4:30 p.m. (Eastern Time)
“I am optimistic about the durable disease control observed in the two heavily pre-treated metastatic patients with Ewing sarcoma, and that both tolerated their treatments with TK216 with or without vincristine well,” said Dr. Joseph Ludwig, M.D. Department of Sarcoma Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center. “Advanced, refractory Ewing sarcoma is a serious and devastating condition, and novel therapies are desperately needed. These encouraging interim results from study TK216-01, along with evolving preclinical data, suggest that this agent may warrant further clinical development.”
As of the April 16, 2021 data cut-off date, a total of 68 patients with relapsed/refractory Ewing sarcoma have been treated with TK216 in study TK216-01, 29 patients in the dose-finding cohorts, and 39 patients treated at the RP2D of TK216 (200 mg/m2/day for 14 days) with vincristine 0.75-1.5 mg/m2 administered on the first day of each cycle. All patients treated at the RP2D had metastases at study entry and were heavily pretreated, with a median number of three prior systemic therapies (range 1-8). Two patients treated at the RP2D have achieved marked and sustained regression in target lesions after as little as two cycles of therapy. The first patient experienced 100% regression of target lesions following two cycles of TK216 alone. After six cycles of treatment that included concomitant vincristine starting in the third cycle, a single 7 mm non-target lung lesion was resected, resulting in a surgical complete remission. The patient remained on study with no evidence of disease after more than 24 months. The second patient attained 90% resolution of target lung lesions following two cycles of TK216 plus vincristine, then achieved a CR after six cycles of therapy. This patient also remained on study disease-free after more than 14 months, treated with TK216 alone following cycle 5. At the RP2D, the objective response rate (ORR) was 9.7% (3 of 31 evaluable patients), including one patient with an unconfirmed partial response (PR). Eleven patients (35.5%) had stable disease (SD), for a disease control rate (CR, PR, SD) of 45.2% (14 of 31 evaluable patients). The median progression-free survival (PFS) for patients treated at the RP2D was 1.9 months (95% CI: 1.5, 3.0), with an encouraging tail of extended PFS for some patients. Updated safety data showed that TK216 at the RP2D has been generally well tolerated, with frequent side effects including myelosuppression, fatigue, and alopecia. No unexpected off-target toxicities or deaths related to TK216 toxicity have been observed.
“We are encouraged by the durable clinical responses in this updated clinical data set, and the sustained disease control observed in two heavily pre-treated patients with refractory metastatic Ewing sarcoma treated with TK216 with or without vincristine,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “This first-in-class investigational agent may also have potential in a variety of other malignancies driven by ETS alterations including acute myeloid leukemia, large B-cell lymphoma and prostate cancer.”
About TK216
TK216 is an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins including fusion proteins. Tumorigenic fusion proteins involving the EWS protein and an ETS protein can be found in most cases of Ewing sarcoma. ETS-related translocations or overexpression are also found in many other tumors such as prostate cancer, acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). TK216 was developed based on discoveries in the laboratory of Jeffrey Toretsky, M.D., at Georgetown Lombardi Comprehensive Cancer Center, who discovered inhibitors of EWS-FLI1 using a novel chemical screening assay. In preclinical models, TK216 was observed to bind to EWS-FLI1, blocking the interaction between this fusion protein and other transcriptome proteins such as RNA helicase A, leading to tumor cell apoptosis and inhibiting tumor growth in animal models. The U.S. Food and Drug Administration (FDA) has granted Orphan Designation, Fast Track designation, and Pediatric Rare Disease Designation to TK216 for the treatment of Ewing sarcoma. TK216 is an investigational medication that has not been approved by the FDA for any indication.
About Study TK216-01
TK216 is being evaluated in an ongoing Phase 1/2 clinical study as a single agent and in combination with vincristine in patients with relapsed or refractory Ewing sarcoma, a rare pediatric cancer with no standard treatment available after first-line chemotherapy. The dose-finding portion of the study is complete. Oncternal is currently enrolling patients in a Phase 2 expansion cohort to evaluate the clinical response of treatment with TK216 in combination with vincristine using the recommended Phase 2 dosing regimen. This multi-center study is enrolling patients at nine clinical trial centers across the U.S. Additional information about the TK216 study may be accessed at ClinicalTrials.gov ( NCT02657005).
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of cancers with critical unmet medical need. Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation or progression. The clinical pipeline includes cirmtuzumab, an investigational monoclonal antibody designed to inhibit the ROR1 pathway, a type I tyrosine kinase-like orphan receptor, that is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) and in an investigator-sponsored, Phase 1b clinical trial in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer, as well as a Phase 2 clinical trial of cirmtuzumab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Oncternal is also developing a chimeric antigen receptor T cell ( CAR-T) therapy that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors. The clinical pipeline also includes TK216, an investigational targeted small-molecule inhibitor of the ETS family of oncoproteins, that is being evaluated in a Phase 1/2 clinical trial for patients with Ewing sarcoma alone and in combination with vincristine chemotherapy. More information is available at globenewswire.com.
Bladerunner
P.S. To my untrained eye, this data looks quite strong to me. Comments?
More on B. Riley's initiation of coverage of MGTA
Magenta Therapeutics Shares Up 16%; B. Riley Initiates at Buy
BY Dow Jones & Company, Inc.
— 12:35 PM ET 05/18/2021
Magenta Therapeutics Inc. ( MGTA
) shares were up 16% to $12.04 in early afternoon trading.
B. Riley initiated coverage on the stock at Buy with a $21 price target.
"We are initiating coverage of Magenta Therapeutics Inc. ( MGTA
) with a Buy rating and a 12-month price target of $21 per share based on our conviction that the company's core pipeline programs could fundamentally revolutionize key prerequisite steps for conducting hematopoietic stem cell transplants," the firm said in an analyst note.
Magenta is a clinical-stage biotechnology company focusing on medicines for stem cell transplant in patients with blood cancers, genetic diseases and autoimmune diseases.
B. Riley said the company's core pipeline is addressing an area of high unmet need, which could enable broader market adoption. B. Riley said that based on its estimates, an additional 12,000 more bone marrow transplants are possible per year in the U.S. and EU if Magenta's lead products are successful. (This is the type of drug that could create its own market, as patients who were previously not eligible or who were very reluctant to seek bone marrow transplant may now do so--Blade)
"We project that the company's mobilization and conditioning programs could bring in a combined $1.5B in risk- unadjusted peak sales, respectively, across a range of indications," the analyst note said.
Bladerunner
MGTA: B. Riley initiates coverage of MGTA with $21 price target
Bladerunner
'Re-opening' looks premature - >>> UK readies for major reopening but new variant sparks worry
Washington Post
By Jill Lawless
May 16, 2021
https://www.washingtonpost.com/politics/uk-readies-for-major-reopening-but-new-variant-sparks-worry/2021/05/16/225910f0-b63a-11eb-bc4a-62849cf6cca9_story.html
LONDON — Travelers in England were packing their bags, bartenders were polishing their glasses and performers were warming up as Britain prepared Sunday for a major step out of lockdown — but with clouds of worry on the horizon.
Excitement at the reopening of travel and hospitality vied with anxiety that a more contagious virus variant first found in India is spreading fast and could delay further plans to reopen.
Cases of the variant have more than doubled in a week in the U.K., defying a sharp nationwide downward trend in infections and deaths won by hard-earned months of restrictions and a rapid vaccination campaign. A surge in testing and stepped-up vaccination effort was being conducted in the northern England areas hardest hit by that variant.
Health Secretary Matt Hancock said the variant, formally known as B.1.617.2, is more transmissible than the U.K.’s main strain and “it is likely it will become the dominant variant.”
“This isn’t over yet,” Hancock told the BBC on Sunday. “The virus has just gained a bit of pace and we’ve therefore all got to be that bit much more careful and cautious.”
On Monday, people in England will be able to eat a restaurant meal indoors, drink inside a pub, go to a museum, hug friends and visit one another’s homes for the first time in months. A ban on overseas holidays is also being lifted, with travel now possible to a short list of countries with low infection rates. Scotland, Wales and Northern Ireland are following similar but slightly different reopening paths.
Patrick Dardis, chief executive of brewery and pub chain Young’s, said the indoor opening — which follows the reopening of outdoor patios and beer gardens last month — is “a big step back on to the path to normality.”
“The weather has been pretty dire, and people are hardy, but we really needed this next step to come,” he said.
But hospitality and entertainment venues say they won’t be able to make money until they can open at full capacity. That’s due to happen June 21, the date set by the government for lifting its remaining COVID-19 restrictions, including social distancing and mask-wearing rules.
Prime Minister Boris Johnson has said if the new variant causes a big surge in cases, it could scupper that plan.
Britain has recorded almost 128,000 coronavirus deaths, the highest reported toll in Europe. But new infections have plummeted to an average of around 2,000 a day, compared with nearly 70,000 a day during the winter peak, and deaths have fallen to single figures a day.
Almost 70% of British adults have received a first dose of a coronavirus vaccine, and more than 37% have had both doses.
Health officials, backed by the army, are carrying out surge testing in Bolton and Blackburn in northwest England, where cases of the new variant are clustered, and pop-up vaccination sites have been set up to speed the inoculation drive. Across the country, the government is shortening the gap between doses for people over 50 from 12 to eight weeks in a bid to give them more protection.
Hancock said scientists had a “high degree of confidence” that current vaccines work against the Indian-identified variant.
Critics of Britain’s Conservative government say lax border rules allowed the new variant to enter the country. They accuse the government of delaying a ban on visitors from India, which is experiencing a devastating coronavirus outbreak, because it is seeking a trade deal with the vast country.
India was added to the U.K.’s high-risk “red list” on April 23, weeks after neighbors Pakistan and Bangladesh.
“We shouldn’t be in this situation,” said opposition Labour Party lawmaker Yvette Cooper. “This was not inevitable.”
The government denies that its health policies were influenced by political or trade considerations.
Mark Walport, a member of the government’s Scientific Advisory Group for Emergencies, said Britain was at a “perilous moment,” and people should be cautious with their new freedoms.
“My advice is that just because you can do something doesn’t necessarily mean you should,” he told Sky News. “As far as possible, socialize outside, maintain social distancing. If you’re going to hug, hug cautiously.”
<<<
>>> Oppenheimer Starts F-Star Therapeutics Inc. (FSTX) at Outperform
StreetInsider.com
April 15, 2021
https://www.streetinsider.com/Analyst+Comments/UPDATE%3A+Oppenheimer+Starts+F-Star+Therapeutics+Inc.+%28FSTX%29+at+Outperform/18268042.html?classic=1
Oppenheimer analyst Jartaj Singh initiates coverage on F-Star Therapeutics Inc. (NASDAQ: FSTX) with a Outperform rating and a price target of $30.00.
The analyst comments "We are initiating coverage on F-star Therapeutics (FSTX) with an Outperform rating and a $30 PT. We believe FSTX screens well among various bispecific antibody (BsAbs) platforms evolving rapidly in the past two years, given the company platform's ability to leverage the three key features of BsAbs: conditionality / crosslinking / clustering through its molecules' Fc-gamma receptor (Fc?R) independent tetravalent binding and generate uncorrelated high-value oncology assets. In our opinion, FSTX's story has checked the boxes for:
(1) a biomarker-driven targeted oncology approach identifying a patient population subset that allows accelerated approval;
(2) enhanced risk/benefit profile with low immunogenicity/high-affinity target engagement/no hook effect/etc.;
(3) unveiling novel target synergy unattainable by mAbs combination; and
(4) experienced/execution-focused management. We are bullish on the story."
For an analyst ratings summary and ratings history on F-Star Therapeutics Inc. click here. For more ratings news on F-Star Therapeutics Inc. click here.
Shares of F-Star Therapeutics Inc. closed at $9.85 yesterday.
<<<
BPTH reports 1st quarter results.
Company is being valued at cash; EV of ZERO. It would seem to be worth more than that. Unknown on The Street. A lottery ticket.
GlobeNewswire
Bio-Path Holdings Reports First Quarter 2021 Financial Results
Bio-Path Holdings, Inc.
Fri, May 14, 2021, 4:00 AM
BPTH
+0.78%
Conference Call to be Held Today at 8:30 A.M. ET
HOUSTON, May 14, 2021 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the first quarter ended March 31, 2021 and provided an update on recent corporate developments.
“The start of 2021 has been marked by substantial progress across our portfolio of targeted nucleic cancer drugs which included both presented and published data in support of our DNAbilize platform,” stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “We recently announced the successful completion of the safety run-in of Stage 2 of the Phase 2 clinical study of prexigebersen for the treatment of acute myeloid leukemia (AML) in combination with frontline therapies, decitabine and venetoclax. This was particularly important as the efficacy portion of this study will include de novo fragile AML patients for whom a clean safety profile will be critical.”
“Last month, we were particularly pleased to have supportive preclinical data from our BP1002 program presented before an audience of world-leading cancer specialists at the AACR Annual Meeting and to have published an analysis highlighting the potential of prexigebersen within the oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines. This presentation and publication significantly enhanced the oncology community’s awareness of the potential for our DNAbilize platform in a variety of hard to treat cancers and we look forward to building on this momentum throughout the remainder of this year,” continued Mr. Nielsen.
Recent Corporate Highlights
Announced Publication in Biomedicines. In April, Bio-Path announced the publication of an analysis highlighting the potential of prexigebersen (BP1001) within the antisense oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines.
Presented BP1002 Data at 2021 AACR Annual Meeting. In April, Bio-Path presented a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research (AACR) Annual Meeting. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. The data presented in the AACR poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies.
Successfully Completed Safety Cohort of Triple Combination in Stage 2 of Phase 2 Clinical Trial in AML. In April, Bio-Path announced the successful completion of the safety run-in of Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients. The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.
Raised $13.0 Million in Public Offering. In February, Bio-Path announced the closing of a public offering for 1,710,600 shares of common stock at a price of $7.60 per share, for aggregate gross proceeds to the Company of approximately $13.0 million, before deducting the fees and estimated offering expenses payable by the Company.
Received Third U.S. Patent Grant Related to Manufacture of Platform Technology. In February, Bio-Path announced that the United States Patent and Trademark Office granted U.S. Patent No. 10,898,506 titled, "P-ethoxy nucleic acids for liposomal formulation." The new patent builds on earlier patents granted that protect the platform technology for DNAbilize®, the Company’s novel RNAi nanoparticle drug.
Financial Results for the First Quarter Ended March 31, 2021
The Company reported a net loss of $2.4 million, or $0.43 per share, for the three months ended March 31, 2021, compared to a net loss of $3.3 million, or $0.90 per share, for the three months ended March 31, 2020.
Research and development expense for the three months ended March 31, 2021 decreased to $1.3 million, compared to $2.0 million for the three months ended March 31, 2020 primarily due to decreased preclinical expense related to timing of activities for BP1003 as well as decreased clinical trial expense due to timing of activities for our Phase 2 clinical trial of prexigebersen in AML and our Phase 1 clinical trial of BP1002 in lymphoma.
General and administrative expense for the three months ended March 31, 2021 decreased to $1.2 million, compared to $1.3 million for the three months ended March 31, 2020 primarily due to decreased franchise tax expense.
As of March 31, 2021, the Company had cash of $30.8 million, compared to $13.8 million as of December 31, 2020. Net cash used in operating activities for the three months ended March 31, 2021 was $1.6 million compared to $2.5 million for the comparable period in 2020. Net cash provided by financing activities for the three months ended March 31, 2021 was $18.6 million.
Conference Call and Webcast Information
Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these first quarter 2021 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 5064037. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous infusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and prexigebersen-A, a drug product modification of prexigebersen, is under consideration by the FDA to commence a Phase 1 study in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it is being evaluated in a Phase 1 study in advanced lymphoma and CLL patients.
For more information, please visit the Company's website at http://www.biopathholdings.com.
Bladerunner
$IBIO IBIO-201, the Company’s vaccine candidate combining antigens derived from the spike protein (“S protein”) fused with iBio’s patented LicKM™ booster molecule, recently completed IND-enabling toxicology studies. The studies identified no adverse effects at low or high doses.
“Combined with data from previous immune-response studies, these pathology results help demonstrate the potential value of LicKM as a useful tool in our vaccine development toolbox,” said Tom Isett, Chairman and CEO of iBio.
https://ir.ibioinc.com/news-events/press-releases/detail/157/ibio-reports-successful-covid-19-vaccine-toxicology-study
MGTA raises cash
Magenta announces private placement worth $86.4M
May 12, 2021 11:11 AM ETMagenta Therapeutics, Inc. (MGTA)By: Jonathan M Block, SA News Editor
Magenta Therapeutics (NASDAQ:MGTA) has announced a private placement of 9.6M shares priced at $9/share for expected gross proceeds of $86.4M.
Institutional investors include Deep Track Capital, TCG X, Great Point Partners, OrbiMed, and Janus Henderson Investors
The closing is expected on May 14.
Magenta shares are up 3.6% to $12.143 in morning trading.
Bladerunner
MGTA surges on preliminary data from cell mobilization study
Magenta posts positive preliminary results from mid-stage multiple myeloma study
May 12, 2021 10:23 AM ETMagenta Therapeutics, Inc. (MGTA)By: Aakash Babu, SA News Editor
Magenta Therapeutics (MGTA +0.8%) announces positive preliminary results from its Phase 2 clinical trial of MGTA-145 plus plerixafor in patients with multiple myeloma.
The investigator-initiated, 25-patient Phase 2 open-label clinical trial is designed to evaluate the ability of the drug combination to mobilize and collect stem cells for autologous stem cell transplant in patients with multiple myeloma.
All patients (10/10) met the primary endpoint of mobilization and collection of 2 million CD34+ stem cells per kg in up to two days of same-day mobilization and apheresis.
All transplanted patients (6/6) successfully engrafted, with median recovery of neutrophils after 12 days and platelets after 17 days, which are within transplant expectations in multiple myeloma.
The trial continues to enroll patients and Magenta expects to report additional data at the EHA Congress, as well as at the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in June.
Bladerunner
CRIS jumps (65%) after showing impressive results in hematological cancers
Curis jumps after blood cancer trial indicates impressive results
May 12, 2021 11:29 AM ETCuris, Inc. (CRIS)By: Dulan Lokuwithana, SA News
Curis (CRIS +58.7%) is surging after announcing updated data from its ongoing open-label, single-arm, Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS).
As of data cut off on February 8, 2021, in 15 patients (8 MDS and 7 AML), four objective responses were recorded with signs of hematologic recovery.
The included one complete response (CR), one complete remission with incomplete hematologic recovery (CRi) with negative minimal residual disease, and two bone marrow CRs, the company said.
The two abstracts with updated data have been accepted for oral and poster presentation at the upcoming European Hematology Association 2021 Virtual Congress (EHA).
CA-4948 is an IRAK4 kinase inhibitor that is believed to be involved in toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways.
TLR and IL-1R pathways are frequently dysregulated in patients with AML and MDS.
Rigel Pharmaceuticals (RIGL +16.5%) is also rising in conjunction. The company has a partnership with BerGenBio for BGB324 (bemcentinib), a first-in-class selective AXL kinase inhibitor.
BGB324 is undergoing Phase 1/2 studies as a single agent for relapsed AML and MDS. and in combination with erlotinib (Tarceva) in advanced (EGFR-positive) non-small-cell lung carcinoma.
Bladerunner
Blade, Thanks. I did get some FSTX yesterday, but then quickly wimped out today after seeing the broader market selling off. Only 300 shares, and I managed to break even, but I've become a nervous nellie when it comes to bio stocks, and stocks in general. After a great 2020 and Q1-21 I don't want to give back those gains. The broader market looks overbought anyway, so I'm sitting with over 50% in cash and T-Bills. The volatility in biotech is just too much for my frazzled nerves, lol. Still interesting to follow them though :o)
MYOV announces end of fiscal year results. Hard to imagine a more positive announcement. Stock remains cheap, IMO.
GlobeNewswire
Myovant Sciences Announces Corporate Updates and Financial Results for Fourth Fiscal Quarter and Fiscal Year Ended March 31, 2021
Myovant Sciences, Inc.
Tue, May 11, 2021, 3:58 AM·19 min read
MYOV
+1.96%
Fourth fiscal quarter 2020 total revenues of $24.6 million; net product revenue from sales of ORGOVYX in the U.S. of $3.6 million
FDA review of New Drug Application for relugolix combination tablet for uterine fibroids remains on track for a decision by June 1, 2021 target action date; U.S. launch expected in June 2021, if approved
Remain on track to submit U.S. regulatory filing for endometriosis in the second quarter of calendar year 2021
European Commission decision on uterine fibroids Marketing Authorization Application remains on track for mid-calendar year 2021; Gedeon Richter to launch and commercialize, if approved
European Medicines Agency validated Marketing Authorization Application for relugolix for the treatment of advanced prostate cancer
Reported positive data for relugolix combination therapy from Phase 3 SPIRIT extension study in women with endometriosis and from Phase 3 LIBERTY randomized withdrawal study in women with uterine fibroids
Company remains well-capitalized with cash, cash equivalents, marketable securities and committed funding of $726.2 million as of March 31, 2021
BASEL, Switzerland, May 11, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced corporate updates and financial results for the fourth fiscal quarter and fiscal year ended March 31, 2021.
“The ORGOVYX launch is off to a strong start and its differentiated clinical profile has the potential to redefine care for men with advanced prostate cancer. ORGOVYX demand accelerated over the course of the quarter, reflecting our ongoing efforts to educate urologists and medical oncologists about ORGOVYX while improving access and reimbursement for patients. In partnership with Pfizer, we continue to execute on our long-term goal of establishing ORGOVYX as the new standard of care androgen deprivation therapy,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “I am also pleased with the progress we have made in preparing for the U.S. launch of relugolix combination tablet in women with uterine fibroids, which is expected this June. In addition, we have advanced relugolix combination tablet toward a U.S. regulatory submission in endometriosis and our European regulatory submission for relugolix monotherapy for the treatment of advanced prostate cancer was validated by the European Medicines Agency.”
Fourth Fiscal Quarter 2020 and Recent Corporate Updates
ORGOVYX
ORGOVYX was launched in the U.S. and authorized specialty distribution channels were fully stocked in early January 2021. Fourth fiscal quarter 2020 net product revenues for ORGOVYX in the U.S. were $3.6 million.
More than 800 treatment centers have prescribed ORGOVYX to over 2,000 patients, estimated through April 30, 2021.
Through April 30, 2021, Myovant achieved 43% commercial coverage and 51% Medicare Part D coverage for ORGOVYX. Myovant continues to engage in coverage negotiations with key commercial and Medicare Part D payors and remains on track to achieve its goal of broad coverage at the end of calendar year 2021.
Relugolix Monotherapy
On March 29, 2021, Myovant announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the application confirmed that the submission is sufficiently complete for the EMA to begin the review process.
Relugolix Combination Tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
Uterine Fibroids
On March 24, 2021, Myovant and Pfizer announced positive safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study in women with uterine fibroids. The study met its primary endpoint and all three key secondary endpoints. Bone mineral density was maintained through two years in the subset of women continuously treated with relugolix combination therapy (N = 31). The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed.
Endometriosis
On January 26, 2021, Myovant and Pfizer announced that the Phase 3 SPIRIT long-term extension study in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year with minimal and stable bone mineral density loss. The data are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies. These results will be included in the regulatory submission to the U.S. Food and Drug Administration (FDA) for relugolix combination tablet for the treatment of women with endometriosis, expected in the second quarter of calendar year 2021.
Prevention of Pregnancy
On April 12, 2021, Myovant and Pfizer announced that the first patient was dosed in the Phase 3 SERENE study evaluating the contraceptive efficacy of relugolix combination tablet in healthy women ages 18-35 years who are at risk for pregnancy. The SERENE study is designed to enroll 900 sexually active, healthy women ages 18-35 years with presumed normal fertility. The primary efficacy endpoint is the at-risk Pearl Index, defined as the number of on-treatment pregnancies per 100 women-years of treatment. Safety data will also be collected during the study. Results of the SERENE study could support a potential indication of pregnancy prevention for women treated with relugolix combination tablet, if approved.
Executive Appointments
On January 4, 2021, Myovant announced the appointment of David Marek as Chief Executive Officer of Myovant Sciences, Inc. Concurrent with this appointment, Mr. Marek was also appointed Principal Executive Officer of Myovant Sciences Ltd. and a member of its Board of Directors.
On April 5, 2021, Myovant announced the appointment of Lauren Merendino as Chief Commercial Officer of Myovant Sciences, Inc. Ms. Merendino is also a member of Myovant’s Executive Committee.
Expected Upcoming Milestones
FDA decision for relugolix combination tablet for the treatment of uterine fibroids is expected by the June 1, 2021 target action date. If approved, Myovant and Pfizer expect to launch in the U.S. in June 2021. Upon FDA approval, Myovant will receive a $100.0 million regulatory milestone payment from Pfizer.
U.S. regulatory submission to the FDA for relugolix combination tablet for the treatment of women with endometriosis-associated pain is expected in the second quarter of calendar year 2021.
Pfizer’s decision regarding its exclusive option to acquire development and commercialization rights to relugolix in oncology outside of the U.S. and Canada (excluding certain Asian markets) is expected in mid-calendar year 2021. If Pfizer exercises this option, Myovant will receive a $50.0 million payment and will be eligible to receive double-digit royalties on net sales.
European Commission (EC) decision on the uterine fibroids MAA is expected in mid-calendar year 2021. If approved, this launch will be executed by Gedeon Richter Plc. (Richter), Myovant’s commercialization partner for relugolix combination tablet for the uterine fibroids and endometriosis indications in Europe and certain other international markets.
MAA submission to the EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain is expected in calendar year 2021. Richter will be the MAA sponsor.
EC decision on the advanced prostate cancer MAA is expected in calendar year 2022.
Fourth Fiscal Quarter and Fiscal Year Ended March 31, 2021 Financial Summary
Total revenues for the three months and year ended March 31, 2021, were $24.6 million and $59.3 million, respectively. There were no revenues recorded in the comparable prior year periods.
Product revenue, net from sales of ORGOVYX in the U.S. for the three months and year ended March 31, 2021 were $3.6 million.
Collaboration revenue for the three months and year ended March 31, 2021 was $21.0 million and $22.4 million, respectively, and represents partial amortization of the upfront payment received from Pfizer pursuant to the Pfizer Collaboration and License Agreement.
License and milestone revenue for the year ended March 31, 2021 was $33.3 million and represents the partial recognition of revenue associated with the $40.0 million upfront payment and a $10.0 million regulatory milestone payment received from Richter under the Richter Development and Commercialization Agreement.
Cost of product revenue for the three months and year ended March 31, 2021, was $0.3 million related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. There were no such expenses for the comparable prior year periods.
Collaboration expense to Pfizer for the three months and year ended March 31, 2021, was $1.7 million, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX in the U.S., pursuant to the Pfizer Collaboration and License Agreement. There were no such expenses for the comparable prior year periods.
Research and development (R&D) expenses for the three months ended March 31, 2021, were $21.6 million compared to $41.7 million for the comparable prior year period. R&D expenses for the year ended March 31, 2021, were $136.7 million compared to $192.6 million for the prior fiscal year. The decrease in R&D expenses reflects a reduction in clinical study costs as a result of the wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies and cost share reimbursements from Pfizer for certain R&D expenses in the fiscal 2020 periods. This decrease was partially offset primarily by an increase in personnel expenses, mainly driven by the continued expansion of Myovant’s medical affairs organization to support the U.S. commercial launch of ORGOVYX and the potential U.S. commercial launches of relugolix combination tablet for the women’s health indications, if approved, as well as regulatory expenses and incremental spend on new relugolix development programs.
Selling, general and administrative (SG&A) expenses for the three months ended March 31, 2021, were $78.0 million compared to $22.4 million for the comparable prior year period. SG&A expenses in the year ended March 31, 2021, were $181.4 million compared to $82.3 million for the prior fiscal year. The increase was primarily due to higher expenses related to commercial activities to support the ORGOVYX U.S. launch and commercial readiness activities for the potential U.S. launch of relugolix combination tablet, higher personnel-related costs primarily due to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology sales force, higher share-based compensation expense, and general overhead expenses to support Myovant’s organizational growth. Share-based compensation expense for the three months and year ended March 31, 2021 includes incremental expense of $25.7 million related to the acceleration, modification, and remeasurement of our former Principal Executive Officer’s outstanding equity awards. SG&A expenses for the year ended March 31, 2020 included $10.2 million in share-based compensation expense related to the accelerated vesting of certain equity awards as well as a $3.6 million capital tax accrual.
Interest expense was $3.5 million for the three months ended March 31, 2021, compared to $1.4 million for the comparable prior year period. Interest expense was $10.4 million for the year ended March 31, 2021, compared to $12.7 million for the prior fiscal year. The decrease in interest expense, despite higher outstanding loan balances, was primarily driven by the significantly lower interest rates associated with the Sumitomo Dainippon Pharma Loan Agreement as compared to Myovant’s previously outstanding debt obligations, which were repaid in December 2019.
There was no loss on extinguishment of debt for the year ended March 31, 2021. For the year ended March 31, 2020, Myovant recorded a $4.9 million loss resulting from the early repayment of Myovant’s previously outstanding debt obligations in December 2019.
Interest income for the three months ended March 31, 2021, was less than $0.1 million compared to $0.2 million for the comparable prior year period. Interest income for the year ended March 31, 2021, was $0.2 million compared to $2.6 million for the prior fiscal year. The decrease was primarily due to decreases in interest rates.
Foreign exchange loss (gain) for the three months ended March 31, 2021, was a loss of less than $0.1 million compared to a gain of $0.5 million for the comparable prior year period. Foreign exchange gain for the year ended March 31, 2021, was $16.2 million compared to $1.6 million for the prior fiscal year. The increase for the year ended March 31, 2021 was primarily due to a larger foreign currency exchange gain on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement during the year ended March 31, 2021 compared to the prior year.
Net loss for the three months ended March 31, 2021, was $81.4 million compared to $64.9 million for the comparable prior year period. Net loss for the year ended March 31, 2021, was $255.1 million compared to $289.0 million for the prior fiscal year. On a per common share basis, net loss was $0.89 and $0.73 for the three months ended March 31, 2021 and 2020, respectively, and $2.83 and $3.37 for the year ended March 31, 2021 and 2020, respectively.
Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $726.2 million as of March 31, 2021, and consisted of $684.9 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.
Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, May 11, 2021, to discuss corporate updates and financial results for its fourth fiscal quarter and fiscal year ended March 31, 2021. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S. The webcast will be archived on Myovant’s Investor Relations website following the call.
About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Relugolix monotherapy (120 mg) is FDA-approved as ORGOVYX™ for the treatment of adult patients with advanced prostate cancer and is under regulatory review in Europe for the treatment of men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in the U.S. and Europe for women with uterine fibroids, has completed Phase 3 registration-enabling studies for women with endometriosis, and is being assessed for contraceptive efficacy in healthy women ages 18-35 years who are at risk for pregnancy.
About Myovant Sciences
Myovant Sciences (Myovant) aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. ORGOVYX™ (relugolix) was approved by the FDA in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix is also under regulatory review in Europe for men with advanced prostate cancer. Myovant’s lead product candidate, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg), is under regulatory review in the U.S. and Europe for women with uterine fibroids, has completed Phase 3 registration-enabling studies for women with endometriosis, and is being assessed for contraceptive efficacy in healthy women ages 18-35 years who are at risk for pregnancy. Myovant is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit Myovant’s website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including the U.S., Japan, China, and the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.
About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is the majority shareholder of Myovant, and wholly owns Urovant Sciences, Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s pipeline is comprised of commercialized and investigational medicines across a range of disease areas targeting high unmet need. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. For further information about Sumitovant, please visit https://www.sumitovant.com.
Bladerunner
gfp,
re: FSTX
My cancer docs think bi-specific tetravalent technology could be a big thing in oncology. The financing was really crappy and I'm pissed. But I remain long. If I had any cash I would be a buyer here.
Bladerunner
Blade, Just curious if you see this as possibly a good buying opportunity for FSTX, with the stock trading down at/near the $7 stock offering price.
Thanks.
Looks like this financing more than doubles the shares outstanding, but that is coming off of tiny base, and the company should now have plenty of cash for a while. Thanks for any insights.
ONCT announces two abstracts for presentation at (virtual) ASCO
Oncternal Therapeutics Announces Presentation of Two Abstracts at ASCO 2021 Virtual Meeting
Oncternal Therapeutics
Wed, April 28, 2021, 7:00 AM
ONCT
+1.72%
SAN DIEGO, April 28, 2021 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the presentation of two abstracts at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting being held virtually from June 4-8, 2021.
Oral Presentation:
Abstract Number for Publication: 11500
Abstract Title: TK216 for relapsed/refractory Ewing sarcoma: Interim phase 1/2 results
Session Title: Sarcoma
Session Date and Time: June 4, 2021 from 1:30 pm - 4:30 pm Eastern Time
Poster Presentation:
Abstract Number for Publication: 7556
Abstract Title: Phase 1/2 study of cirmtuzumab and ibrutinib in mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL)
Poster Session: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: June 7, 2021 at 11:30 am Eastern Time
About TK216
TK216 is an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins including fusion proteins. Tumorigenic fusion proteins involving the EWS protein and an ETS protein can be found in most cases of Ewing sarcoma. ETS-related translocations or overexpression are also found in many other tumors such as prostate cancer and acute myeloid leukemia (AML). TK216 was developed based on discoveries in the laboratory of Jeffrey Toretsky, M.D., at Georgetown Lombardi Comprehensive Cancer Center, who discovered inhibitors of EWS-FLI1 using a novel chemical screening assay. In preclinical models, TK216 was observed to bind to EWS-FLI1, blocking the interaction between this fusion protein and other transcriptome proteins such as RNA helicase A, leading to tumor cell apoptosis and inhibiting tumor growth in animal models. The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation, Orphan Drug Designation and Fast Track Status to TK216 for the treatment of Ewing sarcoma. TK216 is an investigational medication that has not been approved by the FDA for any indication.
About Cirmtuzumab
Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of MCL or CLL, in a collaboration with the University of California San Diego (UC San Diego) School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, Oncternal is supporting two investigator-sponsored studies being conducted at the UC San Diego School of Medicine: (i) a Phase 1b clinical trial of cirmtuzumab in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer, and (ii) a Phase 2 clinical trial of cirmtuzumab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL.
ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen – not usually expressed on adult cells, and its expression confers a survival and fitness advantage when reactivated and expressed by tumor cells. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab, that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. The FDA has granted Orphan Drug Designations to cirmtuzumab for the treatment of MCL and CLL/small lymphocytic lymphoma. Cirmtuzumab is in clinical development and has not been approved by the FDA for any indication.
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of cancers with critical unmet medical need. Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation or progression. The clinical pipeline includes cirmtuzumab, an investigational monoclonal antibody designed to inhibit the ROR1 pathway, a type I tyrosine kinase-like orphan receptor, that is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) and in investigator-sponsored, Phase 1b clinical trial in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer, as well as a Phase 2 clinical trial of cirmtuzumab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. We are also developing a chimeric antigen receptor T cell (CAR-T) therapy that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors. The clinical pipeline also includes TK216, an investigational targeted small-molecule inhibitor of the ETS family of oncoproteins, that is being evaluated in a Phase 1/2 clinical trial for patients with Ewing sarcoma alone and in combination with vincristine chemotherapy. More information is available at https://oncternal.com.
Bladerunner
Blade, Thanks. The daily swings in these bio stocks is enough to send a person to the medicine cabinet for some Tagamet or Prozac lol. They are interesting to follow but I've always had trouble owning them for any length of time.
You're right about Dew, he's the bio genius. I remember also being impressed with Biomaven's knowledge, and many of the other posters over there have excellent insights. I think you have probably made the most money at it though :o) It's amazing you haven't gone into semi-retirement and become super cautious/risk averse. My own past misadventures have made me leery of taking undue risk.
KZIA in-licenses global rights to cancer drug from Evotec
April 19, 2021 5:36 AM
KAZIA LICENSES GLOBAL RIGHTS TO EVT801, A NOVEL, FIRST-IN-CLASS, CLINIC-READY, VEGFR3 INHIBITOR, FROM EVOTEC SE
PR Newswire
SYDNEY , April 19, 2021 /PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce that it has entered into a worldwide exclusive licensing agreement and a master services agreement with Evotec SE (FRA: EVT), a leading European drug discovery and development company, for EVT801, a small-molecule, first-in-class oncology drug candidate. Kazia expects to launch a phase I clinical trial of EVT801 in CY2021.
Kazia Therapeutics Limited Logo (PRNewsfoto/Kazia Therapeutics Ltd)
Key Points
Evotec has granted Kazia an exclusive global worldwide license to develop, manufacture, and commercialise EVT801 in all territories and indications.
Under the terms of the agreement, Kazia will pay an immediate upfront of €1 million (AU$ 1.6 million), contingent milestones of up to €308 million (AU$ 480 million) related to achievement of clinical, regulatory, and commercial outcomes over the lifetime of the drug, and a tiered single-digit royalty on net sales.
Evotec is a leading drug discovery and development company, headquartered in Hamburg, Germany , and listed on the Frankfurt Stock Exchange.
EVT801 is a small-molecule inhibitor of VEGFR3. Its primary activity is to inhibit lymphangiogenesis, the formation of new lymphatic vessels around a growing tumour. By doing so, EVT801 is expected to starve the tumour of vital nutrients and to reduce metastasis. EVT801 also has marked activity on the immune system within the tumour and may therefore enhance the activity of immuno-oncology therapies.
Kazia and Evotec have also entered into a master services agreement, under which the two companies will collaborate closely on the further development of EVT801.
EVT801 was originally discovered by Sanofi (NASDAQ: SNY), the largest pharmaceutical company in France and among the five largest in the world and was developed through a partnership between Sanofi and Evotec.
Kazia expects to launch a phase I clinical trial in CY2021. The initial exploratory indications for EVT801 include renal cell carcinoma (kidney cancer), hepatocellular carcinoma (liver cancer), and soft tissue sarcoma.
Kazia CEO, Dr James Garner , commented, "We are delighted to add this tremendously exciting new compound to the Kazia pipeline. Evotec have done first-class work in the early development of EVT801, and the preclinical data package is exceptionally strong. We intend to fast track a phase I clinical trial of the drug, which we expect to commence in CY2021."
He added, "As we have built Kazia over the past five years, our strategy has been to assemble a portfolio of world-class development candidates through in-licensing. The EVT801 transaction is wholly consistent with that strategy. We have demonstrated, through the paxalisib program, our ability to add value to a development candidate, and we intend to similarly accelerate EVT801 via a rich and innovative development program."
Evotec CEO, Dr Werner Lanthaler , commented, "we are very pleased to partner with Kazia for this promising asset, for which we have high hopes. Our corporate strategy does not provide for Evotec to take EVT801 through clinical trials itself, so we have sought to identify a partner who can do justice to the drug's potential. We recognise Kazia's track record and look forward to working together to make EVT801 available to patients and clinicians."
EVT801
EVT801 is a small molecule inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3). It is orally available, and so can be administered to patients by mouth.
For more than two decades, one of the most successful approaches in the treatment of cancer has been to target angiogenesis, the formation of new blood vessels. Drugs which inhibit angiogenesis, such as Avastin® (bevacizumab), starve the growing tumour of nutrients. However, inhibiting angiogenesis also results in hypoxia (low levels of oxygen) around the tumour, and this is thought to generate resistance to treatment. Almost all cancers treated with current anti-angiogenic drugs will eventually develop resistance.
An alternative approach, which may avoid this problem, is to target lymphangiogenesis, which is the formation of new lymphatic vessels. Doing so achieves many of the same objectives as targeting angiogenesis but may avoid the problem of resistance induced by hypoxia. Moreover, the lymphatic system is a common route by which tumours spread (metastasise) throughout the body, and so inhibiting lymphangiogenesis may help to limit the ability of the tumour to spread.
In recent years, several new drug candidates have attempted to inhibit lymphangiogenesis. For example, Nexavar® (sorafenib) inhibits several forms of VEGFR, as well as other targets, and is approved for the treatment of renal cell carcinoma and hepatocellular carcinoma. Several drugs described as angiokinase inhibitors are in development, and some of these inhibit VEGFR3. However, each of these drugs has multiple targets, leading in many cases to significant side effects. The distinguishing feature of EVT801 is a high degree of specificity for VEGFR3, which should allow it to minimise toxicity.
In addition, EVT801 has shown powerful evidence in the laboratory of an ability to change the balance of immune cells within the tumour. Many tumours are resistant to the newest generation of immuno-oncology therapies because they do not contain the right immune cells for the drugs to act upon. It is hoped that administration of EVT801 may help to sensitise these tumours to immuno-oncology therapies such as Keytruda® (pembrolizumab) and Opdivo® (nivolumab) and thereby extend their use.
Kazia expects to explore all these potential uses of EVT801 during the clinical program. The initial focus will be on a phase I study, which is expected to be conducted at one or more leading hospitals in France and to commence in CY2021.
Master Services Agreement
In parallel with the license agreement, Kazia and Evotec have entered into a Master Services Agreement (MSA), under which they will collaborate on the further development of EVT801. Kazia intends to utilise Evotec's substantial capabilities and expertise in research, clinical trial management, biomarker development, and manufacturing, to expedite the development of EVT801.
Investor Conference Call
Kazia is pleased to invite investors to attend a conference call to further discuss the EVT801 in-licensing.
The call will be held on Tuesday 20 April 2021 at 8:00am , Sydney time (AET), which is 6pm on Monday 19 April in New York (ET) and 3pm on Monday 19 April in San Francisco (PT).
Participants will need to pre-register for the call via the following link:
Registration Link: https://s1.c-conf.com/diamondpass/10013602-bric5f.html
Click the 'Register Now' button and follow the prompts to complete pre-registration. You will then receive a calendar invite with dial in numbers, a passcode and a PIN to dial into the conference call.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) is an oncology-focused drug development company, based in Sydney, Australia .
Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021 . Seven additional studies are active in other forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018 , and Fast Track Designation for glioblastoma by the US FDA in August 2020 . In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020 .
Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021 . Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided compelling evidence of synergy with immuno-onocology agents. A phase I study is expected to begin in CY2021.
For more information, please visit www.kaziatherapeutics.com or follow us on Twitter @KaziaTx.
About Evotec SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists.
We operate worldwide and our more than 3,500 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women's health.
On this basis, Evotec has built a broad and deep pipeline of more than 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.
Bladerunner
gfp, I have no hard and fast rules for investing in biotech stocks. I recommend that before you invest in a any biotech that you consult with "Dew Diligence,' the most knowledgeable person in all of biotech and pharmaceuticals. He is brilliant at sniffing out scams in biotech, and he is especially adept at deciphering PR's and CC's for their "hidden" meanings. He can help keep you out of trouble in biotech and that should be your first requirement. (I'm not saying that you can't make money on scam biotechs, but, at least, you ought to know what you're getting into.)
I don't invest in medical device companies. I'm not interested in companies with drugs that are "enhanced" versions of chemotherapeutics. I don't invest in cancer vaccine companies. I'm extremely skeptical of small-cap biotechs that are tackling AD and Parkinson's, but I readily admit that those stocks can take off on the slightest good news.
Biotech is out of favor now, so I think there are some real bargains out there.
Bladerunner
Blade, Thanks. The volatility of these bio stocks is what gets me. I have trouble not taking profits when they appear, even though that could mean missing out on a great longer term stock.
I was wondering if there are some general ground rules that you use, for example selling 1/2 of a position if you get a double? And do you set a stop loss under your positions? Bio stocks mainly move on the clinical progress and news flow, and you look for well funded companies, which is a great parameter, but do you have certain hard/fast rules, or is it a more flexible approach? Any bio sub-sectors that you always avoid, etc?
Thanks for any insights.
gfp, I sold all my PRVB around $12.50. I had 100,000 shares with an average cost basis around $16 and change, so I took a big loss. I just thought there were better places for my money and I could use the tax loss.
Small and micro-cap biotechs are definitely out of favor now and I don't know when that will turn around, if ever.
I'm still holding ONCT and KZIA. My cancer docs love FSTX (needs cash) and MYOV (gotten very cheap). We all love MGTA. Cancer docs also like CRIS a lot. One doc likes MEIP and another one likes TRIL. I own a medium sized position in TRIL. I sold all of my MEIP a long time ago, but may consider re-entering.
I personally like CRVS. Cancer docs are lukewarm on it.
Besides FSTX, the big, big sleeper is BPTH. With a market cap around $45 million, it seems way undervalued. Of course, I said that when it was $7.
I think you should look at MGTA, FSTX and BPTH. All are very cheap and all have explosive upside.
Bladerunner
Blade, Just curious what your strategy is with PRVB in light of the recent developments? I see they have a meeting with the FDA on May 27, which hopefully will clarify things. At these lower levels the stock looks interesting if there can be a timely resolution to the PK/PD issues. But looks like a lot of uncertainty until there is some clarification.
Thanks for any insights.
KZIA also looks like it might be at a good re-entry point, as does ONCT. Any thoughts on these? Thanks.
Fwiw I luckily bailed on all the bio stocks back in Feb/Mar, along with other previously hot/trendy sectors, but some of these are now starting to look cheap. My strategy for the stock allocation is mainly the broad index ETFs (S+P 500), but now those are also looking over-extended. Buy/hold has definitely become more difficult in this market..
PFE has an interest in TRIL, says "Seeking Alpha"
https://seekingalpha.com/article/4419037-trillium-therapeutics-cd47-lead-evokes-pfizer-interest-tril?mail_subject=tril-trillium-therapeutics-cd47-lead-evokes-pfizer-s-interest&utm_campaign=rta-stock-article&utm_content=link-2&utm_medium=email&utm_source=seeking_alpha
Bladerunner
Conix, I'm not a chartist, so you'll have to tell me what these mean.
Bladerunner
Yikes, looks like trouble for PRVB.
I thought something seemed amiss recently with the downward price action, so sold my position last week. Charts aren't especially useful with bio stocks, but sometimes news can leak, or legitimate concerns that investors have can erode the stock price, so I always take the chart into consideration. Oh well, biotech is full of surprises, and that aspect will never change -
>>> Provention Bio Provides Regulatory Update on Biologics License Application for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals
Yahoo Finance
April 8, 2021
https://finance.yahoo.com/news/provention-bio-provides-regulatory-biologics-200100870.html
- Conference call and webcast to be held today at 5:00 p.m. Eastern Time
RED BANK, N.J., April 8, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the Company received a notification on April 2, 2021 from the U.S. Food and Drug Administration (FDA), stating that, as part of its ongoing review of the Company's Biologic License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated in the correspondence that the notification does not reflect a final decision on the information under review.
Additionally, during an informal discussion on April 2, 2021 regarding the agenda for the upcoming Advisory Committee meeting scheduled for May 27, 2021, the FDA informed the Company that it had completed its review of the data and analysis submitted by the Company for its single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study conducted in healthy volunteers. This study evaluated the PK/PD comparability of drug product originating from drug substance manufactured by AGC Biologics, which the Company plans to use for commercialization, and drug product originating from historic drug substance manufactured by Eli Lilly used for the TN-10 study submitted for the teplizumab BLA. The FDA indicated that based on the data it has reviewed to date, the Agency's position is that the PK profiles of the two drug products evaluated in the PK/PD bridging study were not comparable and that additional data would be required before the FDA's considerations could be satisfied. As a follow up, today, the FDA stated to the Company that it is willing to discuss these issues concurrently with its ongoing review.
The FDA intends to continue the review of clinical data submitted in the BLA and to conduct the Advisory Committee meeting, scheduled on May 27, 2021.
"While we believe the FDA's initial feedback will likely result in a delay in timelines within which teplizumab has the potential to be approved by FDA and be made available for at-risk T1D patients, we believe in the comparability of the drug product produced by our partner AGC biologics with Eli Lilly manufactured product. We look forward to working closely with the Agency to address its additional data requirement, so we can deliver teplizumab to patients as soon as possible," said Ashleigh Palmer, CEO and Co-Founder, Provention Bio. "Additionally, we remain enthusiastic about the clinical efficacy and safety data submitted in connection with the BLA in support of teplizumab's potential to address the high unmet needs of at-risk T1D patients and look forward to meeting with the FDA's Advisory Committee and hearing from patients, KOLs and other key stakeholders next month."
Conference Call and Webcast Information:
Provention Bio will discuss these business updates via conference call today at 5:00 pm ET. To access the call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) ten minutes prior to the start time and ask to be connected to the "Provention Bio Call". An audio webcast will also be available on the "Events and Webcasts" page of the Investors section of the Company's website, www.proventionbio.com. An archived webcast will be available on the Company's website approximately two hours after the conference call.
About Teplizumab (PRV-031):
Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) with a filed BLA under Priority Review by the FDA for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals. More than 800 patients have received teplizumab in multiple clinical studies involving more than 1,000 subjects. In previous studies of newly diagnosed patients, teplizumab consistently demonstrated the ability to preserve beta-cell function, a measure of endogenous insulin production. It correspondingly reduced the need for exogenous insulin use. Teplizumab has been granted Breakthrough Therapy Designation by the FDA and PRIME designation by the European Medicines Administration. Provention is currently also evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT study).
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Biologics License Application (BLA) for teplizumab, its lead investigational drug candidate, for the delay or prevention of clinical type 1 diabetes in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA). The Company's pipeline includes additional clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.
<<<
Kazia also looking good, close to 15 today. Here's an analyst report covering the recent licensing deal for China -
https://kza.irmau.com/irm/PDF/3daa28a3-bff3-44dc-a95d-a89c0c01789b/BellPotterKaziaTherapeuticsChinaOutLicenseDeal
H. C. Wainwright raises price target on BPTH to $12. I've been buying more between $7.10 and $7.20.
--Analyst Actions: HC Wainwright Adjusts Price Target on Bio-Path Holdings to $12 From $10, Maintains Buy Rating
BY MT Newswires
— 11:11 AM ET 04/06/2021
11:11 AM EDT, 04/06/2021 (MT Newswires) -- (MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)
Price: 7.40, Change: -0.23, Percent Change: -3.01
Bladerunner
Oppenheimer initiates coverage of ONCT with an "outperform" rating & a $14 price target.
--Analyst Actions: Oppenheimer Starts Oncternal Therapeutics at Outperform with $14 Price Target
BY MT Newswires
— 9:31 AM ET 04/07/2021
09:31 AM EDT, 04/07/2021 (MT Newswires) -- (MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)
Price: 9.06, Change: +0.40, Percent Change: +4.62
Bladerunner
ONCT up 20% today on no news that I'm aware of. Here is the 1-year chart:
https://finance.yahoo.com/quote/ONCT?p=ONCT&.tsrc=fin-srch
ONCT is a favorite of many SI Biotech Contest portfolios.
Bladerunner
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