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Love these left for dead plays as some big money can be made. Been adding on the sell off now waiting for the payoff on an FDA go. GLTY
Merck Seeks More Deals as It Expands Its Cancer Treatments Portfolio
By Jared S. Hopkins
June 19, 2019 5:30 am ET
Merck & Co. is searching for small and midsize deals, including more transactions aimed at expanding its portfolio of cancer treatments beyond the company’s top-selling product Keytruda, according to people familiar with the matter.
Merck has been buying cancer drugmakers with promising therapies and technologies. This month, Merck bought Tilos Therapeutics Inc. for $773 million. In May, it agreed to acquire Peloton Therapeutics Inc. for $1.1 billion.
The goal of the deal making is to both capitalize on the strength of Keytruda and further broaden the company’s non-oncology products, the people said. Merck is also interested in similarly sized deals that would add to its offerings of vaccines and animal-health medicines, the people said.
Drug pricing is complicated and secretive. WSJ explains how the flow of money, drugs and rebates behind the scenes may drive up the price of prescription medicine for consumers.
Keytruda, which unleashes a patient’s own immune system to fight tumors, was once an afterthought buried in Merck’s research-and-development pipeline but has in the past few years become a commercial juggernaut for the company.
The immunotherapy, whose approvals include treating 12 different types of tumors, rang up $7 billion in global sales last year and is projected to be the world’s top-selling drug by 2024, according to research firm EvaluatePharma.
Keytruda’s success has lifted Merck’s market capitalization to a record $217 billion. Since the company released positive study results for Keytruda in April 2018, Merck shares have risen 44%, compared with the S&P 500’s 9% gain.
Now some investors and analysts are starting to worry that Merck may be too dependent on Keytruda for growth. By 2024, Merck’s $20 billion in cancer-drug sales will be nearly 40% of company revenue, JPMorgan Chase & Co. projects. Merck also sells other prescription drugs, in addition to its vaccines and animal-health medicines.
“There is an emerging view, ‘Are they too tied to’” Keytruda, Credit Suisse AG analyst Vamil Divan said in an interview.
Among the likely topics is the company’s vaccines in development, including a potential competitor to Pfizer Inc.’s big-selling Prevnar vaccine, which protects against infections such as pneumonia and meningitis. JPMorgan analysts project Merck’s drug could reach sales of $1.5 billion.
Merck is also developing treatments for HIV/AIDS, chronic cough and heart failure.
The company is investing in its animal-health unit, which sells products for pets and livestock animals. In December, it acquired animal-tech company Antelliq Group for $2.4 billion. Merck is exploring Keytruda as a treatment for pets with cancer, according to a person familiar with the matter.
Yet outside of the company’s pipeline of cancer drugs, analysts haven’t been impressed with Merck’s drugs in development. Dr. Divan of Credit Suisse said the experimental drugs and vaccines target markets that other companies have struggled to succeed in or that are highly competitive.
“It’s up to them to show why they can do better than other companies have in these areas before,” Dr. Divan said.
Cancer, too, is a highly competitive market, which analysts and industry officials expect will get only more competitive as big drugmakers such as GlaxoSmithKline PLC try to build up a presence after staying away.
The intense interest has driven deal making in the sector—and raised premiums for cancer-drug startups. The latest deal came Monday, when Pfizer agreed to pay a 62% premium to buy Array BioPharma Inc. for $10.6 billion.
https://www.wsj.com/articles/merck-seeks-more-deals-11560936600
MEI Pharma: Time To Reload At Key Support Level
Jun. 16, 2019
https://seekingalpha.com/article/4270462-mei-pharma-time-reload-key-support-level
The SocialMedwork today:
Copiktra (duvelisib)
Copiktra (duvelisib) is a medication used for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and follicular lymphoma (FL) after at least two prior therapies.
How to buy Copiktra (duvelisib): You can order Copiktra (duvelisib) from TheSocialMedwork if the drug has not been approved or is not available in your country.
We provide access to newly approved medicines worldwide.
https://thesocialmedwork.com/pt/copiktra-duvelisib
From 2018
Impatient patients turn to online ‘buyers club’ for new drugs
KEY POINTS
Social Medwork sees its network as filling a gap in the market for the latest drugs against diseases such as cancer, migraine and multiple sclerosis.
In the past 18 months, the group has supplied more than 3,000 patients.
The Dutch group, which charges a fee of around 6 percent, claims to be the only organization focused on newly approved branded drugs.
Frustrated by delays in new medicines reaching their own country, a small but growing number of patients are turning to an online broker that bills itself as a legal version of the Dallas Buyers Club.
While regulators warn of the risk of buying drugs online, the Amsterdam-based Social Medwork sees its network of trusted suppliers as filling a gap in the market for the latest drugs against diseases such as cancer, migraine and multiple sclerosis.
Now it is looking to raise its profile and expand, by signing up former EU Commissioner Neelie Kroes to its supervisory board and securing 1.5 million euros ($1.73 million) in new funding from the Social Impact Ventures capital fund.
Like Ron Woodroof, the 1980s AIDS patient in the movie ‘Dallas Buyers Club’, patients who cannot get the drugs they want through local healthcare systems are using the organization to self-import medicines from abroad.
But while Woodroof had to smuggle drugs across the Mexican border, the Social Medwork’s customers can place orders online legally, as long as they have a prescription and a doctor’s letter stating that the drug is strictly for personal use.
In the past 18 months, the group, which is registered with the Dutch Ministry of Health as a medicines intermediary, has supplied more than 3,000 patients.
They include British migraine sufferer Senty Bera, 43, who recently used the system to buy Aimovig, a new monthly migraine injection from Amgen and Novartis, the first in an improved class of drugs that target a chemical involved in triggering attacks.
“My quality of life was so poor I thought it was worth trying and it is working brilliantly,” Bera said.
As yet, Aimovig is not approved for use within Britain’s state health service - though Bera hopes it will be soon - but its reputation means it is one of Social Medwork’s top-sellers, despite a price tag of 698 euros for two autoinjectors.
A spokeswoman for Britain’s Medicines and Healthcare products Regulatory Agency confirmed there were no formal restrictions on importing such medicines for personal use.
In the past, informal drug-buying networks here have helped supply cheap generic versions of treatments for HIV and hepatitis C. But the Dutch group, which charges a fee of around 6 percent, claims to be the only organization focused on newly approved branded drugs.
With customers in 70 countries, its line-up includes new cancer drugs that are U.S.-approved but not yet available elsewhere, as well as medicines for chronic disorders, such as Roche’s new multiple sclerosis treatment Ocrevus.
Founder Sjaak Vink says the Internet means patients are increasingly aware they may be waiting months or even years for novel drugs following a first approval elsewhere.
“We really need to bridge this gap because this situation is ridiculous,” he said in an interview.
Vink said he was inspired to found the organization by delays in European availability of Merck’s innovative cancer immunotherapy Keytruda.
Today, his group has customers in Australia, the Middle East and Asia, as well as major European markets such as France, Italy, Germany and Britain, where drug delays could worsen if Brexit disrupts supply lines.
Given relatively speedy U.S. approvals, there are currently fewer customers in America, although there was a spike in U.S. demand last year for Mitsubishi Tanabe Pharma’s amyotrophic lateral sclerosis drug Radicut/Radicava, which was approved first in Japan.
https://www.cnbc.com/2018/10/03/impatient-patients-turn-to-online-buyers-club-for-new-drugs.html
The 7 analysts offering 12-month price forecasts for MEI Pharma Inc have a median target of 7.00, with a high estimate of 11.00 and a low estimate of 5.50. The median estimate represents a +185.71% increase from the last price of 2.45.
Institutional investors control 41.73% of the outstanding shares in MEIP. This represents a greater percentage of ownership than at almost any other company in the Pharmaceuticals: Other industry. Additionally, during the quarter ended March 2019, these large investors purchased a net $846.2 thousand shares.
https://money.cnn.com/quote/shareholders/shareholders.html?symb=MEIP&subView=institutional
Big pharma’s billion-dollar bets
As patents lapse and funding on R&D is cut, big pharma is spending big money on risky takeovers to find the next blockbuster drug. In this animated film, Due Diligence's Arash Massoudi explains how Bristol-Myers Squibb’s $90B takeover of Celgene has set the stage for more to come in 2019.
As investors have exerted pressure on big pharma to cut back spending on research and development that can result in expensive disappointments, incumbents have been acquiring smaller competitors to replenish drug pipelines.
Nimble start-ups, in contrast, are not weighed down by legacy businesses and can focus on innovation. Many fail but those that succeed, or even show promise by producing just one drug, instantly become takeover targets.
Underpinning these acquisitions is a gamble. Should a big company buy a start-up that has potential but has not proven its worth? Or wait and miss out on a short cut to high returns and new products?
https://bigdeal.ft.com/videos/big-pharmas-billion-dollar-bets/?utm_source=TW&utm_medium=publishers&utm_content=image_card
Big pharma’s billion-dollar bets
As patents lapse and funding on R&D is cut, big pharma is spending big money on risky takeovers to find the next blockbuster drug. In this animated film, Due Diligence's Arash Massoudi explains how Bristol-Myers Squibb’s $90B takeover of Celgene has set the stage for more to come in 2019.
As investors have exerted pressure on big pharma to cut back spending on research and development that can result in expensive disappointments, incumbents have been acquiring smaller competitors to replenish drug pipelines.
Nimble start-ups, in contrast, are not weighed down by legacy businesses and can focus on innovation. Many fail but those that succeed, or even show promise by producing just one drug, instantly become takeover targets.
Underpinning these acquisitions is a gamble. Should a big company buy a start-up that has potential but has not proven its worth? Or wait and miss out on a short cut to high returns and new products?
https://bigdeal.ft.com/videos/big-pharmas-billion-dollar-bets/?utm_source=TW&utm_medium=publishers&utm_content=image_card
Big pharma’s billion-dollar bets
As patents lapse and funding on R&D is cut, big pharma is spending big money on risky takeovers to find the next blockbuster drug. In this animated film, Due Diligence's Arash Massoudi explains how Bristol-Myers Squibb’s $90B takeover of Celgene has set the stage for more to come in 2019.
As investors have exerted pressure on big pharma to cut back spending on research and development that can result in expensive disappointments, incumbents have been acquiring smaller competitors to replenish drug pipelines.
Nimble start-ups, in contrast, are not weighed down by legacy businesses and can focus on innovation. Many fail but those that succeed, or even show promise by producing just one drug, instantly become takeover targets.
Underpinning these acquisitions is a gamble. Should a big company buy a start-up that has potential but has not proven its worth? Or wait and miss out on a short cut to high returns and new products?
https://bigdeal.ft.com/videos/big-pharmas-billion-dollar-bets/?utm_source=TW&utm_medium=publishers&utm_content=image_card
JMP Securities invites you to attend its annual life sciences equity research conference, which brings institutional investors together with senior executives of leading publicly traded and privately held companies in the areas of biopharmaceuticals, biotechnology, and medical devices and technologies. Fireside chats and thematic panel discussions incorporating a range of senior executives, key opinion leaders, practitioners and patients will highlight the primary trends shaping the life sciences marketplace today.
Participating Companies
https://jmpls.ljfevents-rsvp.com/participating-companies/
Duvelisib, an oral dual PI3K-d,? inhibitor, efficacy and safety in patients with relapsed or refractory (RR) peripheral T-cell lymphoma: rationale for the phase 2 PRIMO trial
S.M. Horwitz F.M. Foss P. Porcu A. Moskowitz N. Mehta-Shah E. Jacobsen M.S. Khodadoust Y.H. Kim D. Weinstock S. Lustgarten M. Baglio H. Youssoufian J. Brammer
First published: 12 June 2019 https://doi.org/10.1002/hon.33_2629
ePDFPDFTOOLS SHARE
Background: RR PTCL is associated with a poor prognosis, with most therapies inducing responses in <30% of pts and median progression-free survival (PFS) <4 mo. Phosphoinositide-3-kinase (PI3K) pathway has a role in survival and proliferation of malignant T cells, as well as T-cell receptor and cytokine signaling in nonmalignant T cells. Duvelisib (DUV), an oral dual PI3K-d-? inhibitor, exhibited potent activity against T-cell lymphoma (TCL) cell lines in vitro and reprogrammed tumor-associated macrophages from the immunosuppressive M2-like phenotype to the inflammatory M1-like phenotype (Horwitz, Blood 2018). DUV monotherapy 25 mg BID is FDA approved for the treatment of RR CLL/SLL in pts who have received ≥2 lines of prior therapy and RR follicular lymphoma in pts who have received ≥2 lines of prior systemic therapy. The optimal dose of DUV in TCL is undefined. Here we summarize the safety and activity of DUV in pts with RR PTCL from 2 phase 1 studies that support the rationale for the ongoing phase 2 PRIMO study (NCT03372057).
Methods: In the initial phase 1 study (NCT 01476657), pts with RR PTCL received DUV until progression or intolerance, as part of a dose-escalation phase. In a separate phase 1 study (NCT02783625), pts with RR PTCL received DUV 25 mg or 75 mg BID as monotherapy for 1 mo as a lead-in to a combination regimen with either romidepsin (R) or bortezomib (B).
Results: A total of 29 pts with RR PTCL received DUV in the phase 1 studies. Among pts who received the DUV 75-mg dose as monotherapy or lead-in therapy before R, the ORR was 54% and 44%, with CR rates of 15% to 22%, respectively (Table). Notably, ORR was 57% among pts receiving lower dose of DUV (25 mg BID) as lead-in therapy before B. Pts receiving DUV as lead-in had a response at the end of cycle 1. In the phase 1 escalation study, response to DUV typically occurred by the first assessment (cycle 2) and was observed across a spectrum of PTCL subtypes. Two pts who attained a CR and PR, respectively, in the phase 1 escalation study completed >1 year of DUV treatment (Horwitz, Blood 2018). The preliminary safety profile of DUV in pts with PTCL was considered reasonable and consistent with previous reports.
Conclusions: DUV 25 or 75 mg BID demonstrated encouraging clinical activity and an acceptable safety profile in RR PTCL, a population in need of new and effective therapies. The ongoing phase 2 PRIMO study dose optimization phase will identify the optimal regimen of DUV monotherapy in RR PTCL and characterize the efficacy and tolerability of DUV in ˜100 pts.
Disclosures: Horwitz, S: Consultant or Advisory Role: ADCT Therapeutics, Aileron, Forty-Seven, Infinity/Verastem, Kyowa-Hakka-Kirin, Millennium /Takeda, Seattle Genetics, Affimed, Angimmune, Beigene, Corvus, Innate Pharma, Kura, Merck, Miragen, Mundipharma, Portola, Syros Pharmaceutical; Research Funding: ADCT Therapeutics, Aileron, Forty-Seven, Infinity/Verastem, Kyowa-Hakka-Kirin, Millennium/Takeda, Seattle Genetics, Celgene, Trillium. Porcu, P: Consultant or Advisory Role: Innate Pharma, Miragen, Kiowa, Viracta, Seattle Genetics, Beigene; Honoraria: Innate Pharma, Miragen, Kiowa, Viracta; Research Funding: Kura Pharmaceuticals. Moskowitz, A: Honoraria: Kyowa Hakko Kirin Pharma, Miragen Therapeutics, Takeda Pharmaceuticals, ADC Therapeutics, Seattle Genetics, Cell Medica, Bristol-Myers Squibb, Erytech Pharma; Research Funding: Seattle Genetics, Merck, Bristol-Myers Squibb, Incyte. Mehta-Shah N: Consultant or Advisory Role: Kyowa-Hakka-Kirin; Research Funding: Celgene, Verastem, Bristol Myers Squibb, Genentech/Roche. Jacobsen E: Consultant or Advisory Role: Bayer; Honoraria: Seattle Genetics, Merck, Takeda, Astra-Zeneca; Research Funding: Novartis, Hoffman-LaRoche, Pharmacyclics, Merck, Celgene, Seattle Genetics. Khodadoust M: Consultant or Advisory Role: Kyowa Kirin, Inc.; Seattle Genetics. Weinstock D: Research Funding: Verastem. Lustgarten S: Employment or leadership position: Verastem; Stock ownership: Verastem. Baglio M: Employment or leadership position: Verastem; Stock ownership: Verastem. Youssoufian H: Employment or leadership position: Verastem (Head, Medical Strategy); Stock ownership: Verastem.
https://onlinelibrary.wiley.com/doi/10.1002/hon.33_2629
Looking that way and loaded with shares for the long term. GLTY
Zafgen to Present at the JMP Securities Life Sciences Conference
June 13, 2019 16:15 ET | Source: Zafgen, Inc.
BOSTON, June 13, 2019 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel therapies for patients affected by a range of metabolic diseases, announced today that Jeffrey Hatfield, Chief Executive Officer of Zafgen, Inc. is scheduled to present at the JMP Securities Life Sciences Conference on Thursday, June 20, 2019, at 10:30 a.m. ET.
A live audio webcast and replay of the presentation will be available through the Events and Presentations page of the Investors section of the Company's website (www.zafgen.com) for 90 days following the conclusion of the live event.
About Zafgen
Zafgen (Nasdaq:ZFGN) is a clinical-stage biopharmaceutical company leveraging its proprietary MetAP2 biology platform to develop novel therapies for patients affected by complex metabolic diseases. Zafgen has pioneered the study of MetAP2 inhibitors in both common and rare metabolic disorders and is currently advancing programs for type 2 diabetes, Prader-Willi syndrome and liver diseases. Learn more at www.zafgen.com.
Media/Investor Relations Contacts:
Zafgen, Inc.
Patricia Allen
Chief Financial Officer
617-648-9792
Media
Krystle Gibbs
Ten Bridge Communications
krystle@tenbridgecommunications.com
508-479-6358
Investors
John Woolford
Westwicke
john.woolford@westwicke.com
443-213-0506
http://www.globenewswire.com/news-release/2019/06/13/1868702/0/en/Zafgen-to-Present-at-the-JMP-Securities-Life-Sciences-Conference.html
Latest transcript:
Investment Highlights
•
A rare disease focused clinical stage biopharmaceutical company with a pipeline of novel product candidates that are intended
to address unmet need in a variety of metabolic diseases
•
ZGN 1061 for type 2 diabetes with concomitant obesity and/or NASH
•
Diabetes market evolving towards therapies with enhanced A1C lowering efficacy and positive effects on common co morbidities (ob esity/NAFLD)
•
Phase 2 proof of concept trial demonstrated significant A1C lowering efficacy and weight loss, with a safety and tolerability pr ofile generally
comparable to placebo
•
Nonclinical ZGN 1061 studies have demonstrated significant NASH model efficacy, and complementary efficacy in combination with a GLP 1
•
Next milestone: Update on development plans by end of 3Q 2019
•
ZGN 1258 for rare metabolic diseases, including Prader Willi syndrome
•
Prader Willi syndrome is a rare, lethal disease emerging in childhood, with ~200,000 afflicted worldwide; no current therapeutic options available
•
Development plans suspended due to unexpected finding in long term toxicology studies
•
ZGN 1345 for metabolic liver disease
•
Multiple metabolic related liver diseases exist with high unmet medical need, from NAFLD/NASH to hepatocellular carcinoma
•
Compound is an orally dosed MetAP2i with high liver concentrations but minimal to no detectable systemic exposure; once daily do sing expected
•
Named as development candidate 4Q 2018; nonclinical development work underway
•
March 31, 2019 cash position of $105M; runway expected to extend through at least 2020
ZGN
1061 Next Steps
•
Reviewing comprehensive data sets with diabetes/NASH KOLs and potential partners
•
Important progress made toward addressing the FDA Clinical Hold:
•
Received FDA Type A meeting minutes to previously announced clinical hold
•
FDA acknowledged newly developed in vitro assays of human plasma coagulation and tissue factor expression qualitatively
differentiate ZGN 1061
•
Working with FDA to translate in vitro data and confirm relevant safety margins in an in vivo model
•
Exploring a second IND in a population with higher unmet medical need
•
Company expects to provide an update on development plans by end of 3Q 2019
•
Submitting abstracts to present full results of the Phase 2 clinical trial at upcoming medical meetings in 2019
ZGN
1258 Summary
•
Unexpected finding observed in long term toxicology studies
•
Degeneration and other anomalies in muscle tissue from 4 and 6 month rodent studies
•
Observed in different degrees in both vehicle and all dose arms; finding more pronounced at higher doses
•
Finding never observed previously, specific to ZGN 1258
•
Not seen in prior ZGN 1258 rodent studies
•
Not seen in any other species with ZGN 1258
•
Not seen in any other Zafgen MetAP2i program in any long term toxicology study
•
Plan to file an IND suspended while finding is investigated
•
Company will provide an update at a later time, if warranted, following further evaluation
PWS Commitment Continues
•
PATH for PWS natural history study collaboration continues
•
Study being conducted in collaboration with the Foundation for
Prader Willi Research (FPWR) and National Organization for Rare
Disorders (NORD)
•
PATH for PWS designed as 4 year / 500 participant non interventional
natural history study
•
Enrollment kicked off at FPWR annual conference in October; >400
enrolled as of March 2019
ZGN
1345 Oral, Liver Focused MetAP2 Inhibitor
•
ZGN 1345 advanced to development candidate status in 4Q 2018
•
Orally dosed MetAP2i; expected once daily dosing
•
High concentrations in the liver; minimal to no detectable exposure systemically
•
High MetAP2 levels strongly correlated with more severe outcomes in advanced liver disease
•
Positive early data in multiple nonclinical liver disease models with high unmet medical need; further nonclinical
studies ongoing
The 6 analysts offering 12-month price forecasts for Catalyst Pharmaceuticals Inc have a median target of 9.00, with a high estimate of 10.00 and a low estimate of 5.50.
Zafgen (ZFGN)
Cowen & Co. analyst Yaron Werber maintained a Hold rating on Zafgen today. The company’s shares opened today at $1.35, close to its 52-week low of $1.25.
According to TipRanks.com, Werber is a 4-star analyst with an average return of 12.5% and a 61.2% success rate. Werber covers the Healthcare sector, focusing on stocks such as Ultragenyx Pharmaceutical, Inc., Rocket Pharmaceuticals Inc, and Unum Therapeutics Inc.
https://www.analystratings.com/articles/analysts-offer-insights-on-healthcare-companies-zafgen-nasdaq-zfgn-and-pharming-group-other-otc-phguf/
Institutional investors purchased a net $12.300,000 million shares of CPRX during the quarter ended March 2019, and now own 59.81% of the total float, a percentage that is typical for companies in the Pharmaceuticals:
Latest Institutional Activity
3/31/2019 CONSONANCE CAPITAL MANAGEMENT LP Bought 8.5 Million shares of Catalyst Pharmaceuticals
3/31/2019 OPALEYE MANAGEMENT, INC. Bought 1.8 Million shares of Catalyst Pharmaceuticals
3/31/2019 MANGROVE PARTNERS Bought 1.1 Million shares of Catalyst Pharmaceuticals
https://money.cnn.com/quote/shareholders/shareholders.html?symb=CPRX&subView=insider
Zafgen Presented Full Results of Phase 2 Clinical Trial for ZGN-1061 at the American Diabetes Association's 79th Scientific Sessions
Mon June 10, 2019 7:00 AM|GlobeNewswire|About: ZFGN
Delivered comprehensive oral presentation on both cohorts of the clinical trial, including previously announced results for second cohort evaluating doses up to 1.8 mg
Company also presented data demonstrating that treatment with ZGN-1061 improves measures of insulin sensitivity and beta-cell function
BOSTON, June 10, 2019 (GLOBE NEWSWIRE) -- Zafgen (ZFGN), Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel therapies for patients affected by a range of metabolic diseases, today announced that the Company presented the full results of its Phase 2 clinical trial for ZGN-1061 in an oral presentation at the American Diabetes Association's 79th Scientific Sessions. Zafgen also presented a poster on data demonstrating that treatment with ZGN-1061 improved measures of glycemic control, including insulin sensitivity and beta-cell function.
Zafgen previously announced positive results from its Phase 2 clinical trial conducted outside the U.S., including data for the second cohort that included doses up to 1.8 mg, in January 2019. The clinical trial met all of its primary objectives at the 1.8 mg dose, which included glycemic control, or change in A1C, and safety and tolerability. The 12-week data demonstrated that treatment with the 1.8 mg dose of ZGN-1061 produced substantially more improvement in A1C versus placebo than the 0.9 mg dose versus placebo. Progressive and notable reduction in body weight also occurred in patients treated with the 1.8 mg dose. The data showed a favorable safety and tolerability profile for ZGN-1061, with no treatment-related serious adverse events and no cardiovascular (CV) safety signals observed in the trial.
The Phase 2 clinical trial also examined the effects of ZGN-1061 on other markers of glycemic control. In data presented during the poster session, patients who participated in a mixed-meal tolerance test demonstrated significant improvements in postprandial glucose excursion with ZGN-1061 (p<0.001 for both the 0.9 and 1.8 mg doses) and a trend for improvement in insulin levels from baseline to Week 12. ZGN-1061 also demonstrated improvement in beta-cell function and insulin sensitivity in an exploratory combined analysis of 0.9+1.8 mg ZGN-1061 (p=0.02 and p=0.07) using a modeling approach. These data suggest improved glycemic control with ZGN-1061 may be driven by changes in insulin sensitivity and beta-cell function in this population of patients with advanced diabetes.
The poster will be available on the Company’s website.
About Zafgen
Zafgen is a clinical-stage biopharmaceutical company leveraging its proprietary MetAP2 biology platform to develop novel therapies for patients affected by complex metabolic diseases. Zafgen has pioneered the study of MetAP2 inhibitors in both common and rare metabolic disorders. Learn more at www.zafgen.com.
Biopharmaceutical Zafgen (ZFGN) Trading 44% Below Cash Value
Nice now the stock can trade on its own as all the index players have or will drop $VSTM, it's being removed from the Russell Indexes on June 28th, after market close. Beta should drop as a result, which is good. Should see positive effect, starting in July. There are about 2M shares between the two ETFs tied to Russells indexes.
Russell US Indexes
Reconstitution
Russell 3000® Index Deletes
Sector
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I`ve been adding too, maybe more than I had planned, but this is way oversold for all they have going. I`ll just put it away for a few years no matter what the market dose. I`m down $18,000, but never see it as a loss, just a gift buying opportunity. I`m sure if I looked back I have made more than i`ve lost trading $VSTM. Now it's just a hold in my retirement portfolio while management makes me money.GL
Yep , I dropped the ball on this too. Next time around......
Rx numbers latest, I posted to wrong stock board.
Link:
They have applied for Canadian distribution. Ongoing script numbers, "10" 10 retail scripts for the shorten holiday week:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149265095
Finding Abnormal Returns With The Russell Index Rebalancing Every June
https://seekingalpha.com/article/4268687-finding-abnormal-returns-russell-index-rebalancing-every-june
The company is optimistic.
"We believe the new in vitro data generated was encouraging, and the FDA was helpful with guidance regarding data needed to move forward in type 2 diabetes," Zafgen CEO Jeffrey Hatfield said in a statement.
What's Next
Zafgen said it is evaluating serious, rare disease indications for which ZGN-1061 could be useful.
The FDA was supportive of Zafgen seeking guidance on a second investigational new drug application for ZGN-1061 as appropriate.
Zafgen is set to provide an update on development plans by the end of the third quarter.
Forensic Value Selections For June: Long-Term Positive Picks Beating Negative By +18.78%
Jun. 3, 2019 7:05 PM ET | Includes: ANAB, CHRS, CRMD, EPZM, GSUM, MS, OPB, TGTX, TNDM
https://seekingalpha.com/article/4268077-forensic-value-selections-june-long-term-positive-picks-beating-negative-plus-18_78-percent
VJHemOnc – Video Journal of Hematological Oncology
Published on Jun 3, 2019
Ian Flinn, MD, PhD, from Tennessee Oncology, Nashville, TN, delivers an update on the DUO trial (NCT02004522) looking at duvelisib for R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and how PI3K inhibitors will be used in CLL therapy going forward. This interview was recorded at the American Society of Oncology (ASCO) 2019 Annual Meeting, held in Chicago, IL.
These past ratings are not that old yet the share price is depressed due to stocks continue manipulations of shorting and scalping shares daily.
https://www.analystratings.com/articles/tag/nasdaqvstm/
Today Zafgen's hold rating reiterated at Piper Jaffray Companies. $5.00 PT. and Zafgen's buy rating reiterated at Wedbush. $6.00 PT., plus Zafgen's hold rating reiterated at Cowen Inc.
TG Therapeutics May Have Potential but the Charts Need More Work
Shares of this biotech company are up 75% for 2019, despite recent weakness.
https://realmoney.thestreet.com/investing/stocks/tg-therapeutics-may-have-potential-but-the-charts-need-more-work-14972733?puc=yahoo&cm_ven=YAHOO&yptr=yahoo
Latest Institutional Activity
5/20/2019 BVF PARTNERS LP Bought 2.0 Million shares of Verastem Inc
3/31/2019 DWS INVESTMENT GMBH Bought 1.0 Million shares of Verastem Inc
3/31/2019 STONEPINE CAPITAL MANAGEMENT LLC Bought 500.000 Thousand shares of Verastem Inc
Square to manage concessions payments, POS at Indy 500
May 24, 2019
Square is now the Indianapolis Motor Speedway's payment and point-of-sale provider where it will process concessions purchase for more than 300,000 fans of the Indianapolis 500, according to a company press release.
The agreement would allow fans to pay with all major credit cards, as well as the Apple Pay and Google Pay mobile wallets. The venue, which has about 500 concessions stands, previous were cash only at most of the locations.
"Square is excited to be working closely with the Indianapolis Motor Speedway team to eliminate long lines and 'cash only' signs,"Jesse Doroguser, head of hardware at Square said the release. "Square will help their concessions sellers more than double their ability to accept credit cards, while giving valuable time back to their spectators.”
Under the agreement, hawkers at the race will now be able to accept card payments for the first time. The agreement marks the second sports stadium deal by Square this year, following an agreement announced in March with the Washington Nationals to accept in-seat ordering and order-ahead concessions.
https://www.qsrweb.com/news/square-to-manage-concessions-payments-pos-at-indy-500/
BioSci Capital Partners' Blog integrated biosci research, consultant
Dr. Tran BioSci
Please Note: Blog posts are not selected, edited or screened by Seeking Alpha editors.
IBI Research On Verastem: Will Copiktra Saves The Day?
May 24, 2019 4:50 AM ET|1 comment |About: Verastem, Inc. (VSTM), Includes: AKAO, CDTX, MLNT, PRTK
Summary
Verastem is a legitimate therapeutic innovator that conquered the odds to gain regulatory approval for its leads cancer molecule, Coptrika.
To investor's disappointment, Coptrika posted subpar sales after two quarters into launch. Consequently, the stock is depreciating like a falling knife that has yet to find a base.
In assessing commercialization success, you should analyze the all-important "hurdles" to a successful launch. Some examples include partnership, insurance coverage, and lines of recommendation.
Though having a strong balance sheet, Verastem's cash burn is high. Adding further injury to the insult, the capitalization is heading below $100M which reduces the capacity to raise cash.
I believe that Verastem can ramp up Copiktra revenues. Yet the elephant in the room is whether the company will prolong its survival to enjoy the anticipated sales growth.
After years of experience, I can quickly "size up" whether a biotech stock will bank profits for investors in the long-haul. Nevertheless, I occasionally run into an "investment quandary." Specifically, it's can be difficult for me to balance between the need for investment profits for investors versus my ethical responsibility in supporting innovation. If I write negatively investors may sell out and thereby reduces a company's ability to raise cash. Contrarily, if I take a positive position without presenting pertinent facts investors might lose profits.
To my best ability, I decided to take the middle ground by presenting both positive and negative aspects of an investment story. That way, you make your an informed decision on your stocks after you conduct your own due diligence. Of note, you can view the aforesaid quandary by referring back to my recent work on the antibiotic innovators, including Melinta (MLNT), Achaogen (AKAO), Cidara (CDTX), and Paratek (PRTK). These are excellent firms that are ironically unprofitable investments.
Along that theme, I noticed there is another type of companies that are excellent innovators yet subpar investment prospects. Their drugs demonstrated stellar efficacy and safety. Nonetheless, these molecules usually struggle to gain sales traction. A prime example is Verastem Oncology (VSTM). After half-a-year into commercialization, its good drug (Copiktra) has not generated robust sales to convince investors of the company's viability. In this research, I'll feature a fundamental analysis of Verastem and provide my expectation on this stock.
About The Company
For new investors, I'll present a brief corporate overview. If you are familiar with the firm, I suggest that you skip to the subsequent section. Headquartered in Boston Massachusetts, Verastem is focused on the innovation and commercialization of medicines to serve the strong unmet needs in oncology. Poised to battle cancers, Verastem is harnessing the power of two stellar medicines, duvelisib (Copiktra) and defactinib. They're advancing in different phases as the answer to resistant cancers.
In my view, Verastem is the real deal because the company already harvested the initial fruit of regulatory success. Despite PI3K drugs availability, Copiktra heralds as the unprecedented approval of a dual PI3K-delta and PI3K-gamma inhibitor in the U.S. As the third-line treatment, Copiktra is efficacious against the resistant cancers coined chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) as well as follicular lymphoma ("FL"). Though approved, regulatory success is only half the battles won. I believe that the more difficult obstacles entail "hurdles" to successful commercialization.
Copiktra Commercialization
Shifting gears, I'll analyze Copiktra's marketing progress as it's been approximately half-a-year into the launch for CLL/SLL. Moreover, Verastem secured its label expansion to manage patients afflicted by FL. With 120-days post-accelerated approval, Verastem is able to commercialize Copiktra for patients suffering from FL beginning in March this year. The President and CEO (Robert Forrester) remarked,
We are now into the second full quarter of the Copiktra launch and sales were up approximately 38% compared to the prior quarter. We have also made substantial progress securing broader reimbursement for our product, with over 92% of targeted health plans now listing and providing reimbursement for Copiktra. We continue to receive positive feedback from physicians using Copiktra for the treatment of patients with relapsed or refractory CLL/SLL after at least two prior therapies or FL after at least two prior systemic therapies.
Based on Mr. Forrester's remark, it appears that Verastem is "hitting the ground running." I believe that Verastem is realizing concrete commercialization progress for Copiktra. More importantly, the Chief is enthused about laying the growth foundation through stellar initiatives as depicted below. Specifically, the sales expansion is set to occur in four consecutive steps, including Anchor, Broaden Reach, Bold Steps, and Maximize Potential. Forrester elucidated,
The commercial team has been diligently working to enhance physician and advocacy group awareness of Copiktra, and to overcome certain historical misperceptions concerning the PI3K class. We believe the groundwork we have laid over the past several months will have an increasingly positive impact through 2019 and into next year. In parallel, we continue to advance duvelisib in additional lines of therapy, both as a monotherapy and in combination, as well as in additional indications like PTCL for which preliminary data are expected by the end of this year.
In my view, if the first step (Anchor) is successful it'll create a "domino effect" to galvanize growth via subsequent steps. As such, Anchor is strongly correlated with my "investment profitability" score. Notably, investment profitability is a quantitative variable that I devised for my unique system of equity analysis. It essentially gives you a quick assessment of whether a particular stock will bank a profit. Going forward, I'll employ investment profitability exclusively in IBI chat and IBI articles.
Looking at the short-term, it doesn't seem that the investment profitability of Verastem is high. After all, the stock is trading like a freight training heading southbound. On a daily basis, it's not far from the truth that market bears are taking Verastem to the woodshed. Nonetheless, I'm not deterred by that fact. Since I'm an ultra-long-term investor, the short-term volatility is like music to my ears. In my opinion, market inefficiency is born out of volatility. You should not let it scares you out of the investment game.
It's not that I'm automatically immune to the aforesaid market volatility. Through the painstaking systematic fundamental research over the years, I've learned to leverage volatility to my advantage. To determine if there is truly market inefficiency affecting Verastem, I'll walk you through three main criteria that I employed to forecast Copiktra commercialization. I also encourage you to check the prior IBI Educational article for further details on these metrics.
To be continued ...
https://seekingalpha.com/instablog/17806842-biosci-capital-partners/5307919-ibi-research-verastem-will-copiktra-saves-day