Fortress Biotech Inc (FBIO)

[TrendTrade2016]

FBIO THERE'S THE DOLLA Break

[TrendTrade2016]

FBIO CONTINUES ITS CLIMB TO A DOLLA

[TrendTrade2016]

FBIO what a beautiful move off that bottom

[TrendTrade2016]

FBIO building its steam

[TrendTrade2016]

FBIO NEXT BIO READY TO RUMBLE

[conix]

Tou

jmogh market for any stock--but the biotechs rely on investors that are willing and able to see the future potential and not just not quarter's earnings.

It has happened before--and it will happen again. You accumulate shares when no one seemingly wants them. And sell when EVERYONE wants them.

FBIO has never been in a better place in their business plan. Cash flowing positive and a nice pipeline with milestones expected to be met over the next few months.

[conix]

If it is a biotech, they are not moving. Regardless of the news.

This biotech bear market will end some point in time. My prediction? I do not have one.

[conix]

Bought a bit more FBIO on Friday and today. Strange that they are now cash flow positive and, yet, at its multi-year lows.

When biotechs become hot again--and they always do---FBIO should do very well. The big question is when do they start getting hot again?

[conix]

Fortress Biotech (FBIO) Gets a Buy Rating from B.Riley Financial

April 18 2022 - 07:35AM

B.Riley Financial analyst Mayank Mamtani maintained a Buy rating on Fortress Biotech (FBIO – Research Report) today and set a price target of $8.00. The company's shares closed last Thursday at $1.08, equals to its 52-week low of $1.08. According to TipRanks.com, Mamtani is currently ranked with 0 stars on a 0-5 stars ranking scale, with an average return of -27.6% and a 22.4% success rate. Mamtani covers the Healthcare sector, focusing on stocks such as Arrowhead Pharmaceuticals, Madrigal Pharmaceuticals, and Spectrum Pharmaceuticals. The word on The Street in general, suggests a Strong Buy analyst consensus rating for Fortress Biotech with a $14.00 average price target, an 1138.

[conix]

Started to nibble at FBIO down here. FWIW. Not too many biotechs at this price that are cash flow positive

[conix]

FBIO chart--getting interesting for a re-entry.



Biotechs with a story are going to do well over the next two months, imo.

[jfk]

today:
Avenue Therapeutics, Inc. (“Avenue”), received an Appeal Denied Letter from the Office of Neuroscience of the FDA in Response to its Formal Dispute Resolution Request

[mattsinvestmentclub]

Grabbed this on my stockpile account awhile ago.

[jm101dm]

Grabbed some more at 3.75 today. Thanks. FBIO

[ed243383]

A lot of analysts love this stock and has it has a good pipeline. Now if we can just get an FDA approval then we will see a big movement!

[conix]

FBIO chart

[ClayTrader]

* * $FBIO Video Chart 04-12-2021 * *

Link to Video - click here to watch the technical chart video

[Planopenny]

Pump it up

[daleb2130]

Bought in yesterday at $5.06. Bought some Options too.

[Planopenny]

Slow claps

[ClayTrader]

* * $FBIO Video Chart 04-09-2021 * *

Link to Video - click here to watch the technical chart video

[Planopenny]

Boom

[conix]

Aevitas Therapeutics Appoints Markus Peters, Ph.D., M.Sc., as Chief Executive Officer

Catherine Bowes Rickman, Ph.D., FARVO, a leading age-related macular degeneration researcher, appointed to Scientific Advisory Board

NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Aevitas Therapeutics, Inc. (“Aevitas”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) partner company focused on the development of novel gene therapy approaches for complement-mediated diseases, today announced the appointment of Markus Peters, Ph.D., M.Sc., as President and Chief Executive Officer. Dr. Peters was most recently the Chief Operating Officer of Gemini Therapeutics after serving as the Chief Commercial Officer of Agilis Biotherapeutics. Dr. Peters will lead the Company as it advances its proprietary platform designed to deliver engineered, fully functional, shortened complement factor H (CFH) via adeno-associated virus (AAV).

CFH is a major regulator protein of the alternative complement pathway. Mutations and polymorphisms in CFH play a vital role in numerous diseases with high unmet need, spanning from dry age-related macular degeneration (AMD) to atypical hemolytic uremic syndrome (aHUS). The size of the CFH gene makes it too large to fit into a traditional AAV vector. Aevitas’ novel platform focuses on the long-term delivery of a fully functional shortened CFH gene, which is expected to restore proper regulation of the complement cascade.

Aevitas also appointed Catherine Bowes Rickman, Ph.D., FARVO, a leading AMD researcher, to its Scientific Advisory Board (SAB) to support the advancement of its innovative program for the treatment of dry AMD. Dr. Bowes Rickman will join Scientific Founder, Dr. Wenchao Song, Ph.D. of the University of Pennsylvania, and Dr. Guangping Gao, Ph.D. of the University of Massachusetts Medical School. Over the last decade, Dr. Bowes Rickman has focused her research on the impact of the complement system on the pathobiology of AMD.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer and Aevitas’ Executive Chairman, said, “We are pleased to welcome Markus as Chief Executive Officer of Aevitas. His extensive experience with AAV-based gene therapies and complement-mediated diseases, strong global biopharma leadership background, and expertise in the development of novel therapeutics will benefit Aevitas as we advance our shortened CFH gene platform. We also welcome Dr. Bowes Rickman to Aevitas’ SAB. Her expertise in AMD, and research establishing the key role CFH plays in disease progression and susceptibility, will be invaluable.”

“I am excited to be joining Aevitas at this critical juncture for the company, as it advances towards clinical trials,” said Dr. Peters. “With an experienced team and collaborations with leading academic institutions, Aevitas is well positioned to advance with due urgency potential therapies for patients with genetic diseases of the complement system, providing value through the application of its proprietary AAV platform.”

Markus Peters, Ph.D., M.Sc.
Dr. Peters has a 25-year track record of developing and commercializing innovative, high-value orphan and specialty pharmaceuticals for patients with significant unmet medical need. Most recently, he was Chief Operating Officer at Gemini Therapeutics, a precision medicine company developing novel therapeutics to treat genetically defined age-related macular degeneration and related disorders. There, he had responsibility for financing, corporate and pipeline strategy, business development, human resources and general administration. Prior to Gemini, Dr. Peters was Chief Commercial Officer at Agilis Biotherapeutics, a company developing gene therapies for patients with rare diseases of the central nervous system which was acquired in 2018 by PTC Therapeutics in a milestone-based deal valued at $1B. Before that, Dr. Peters held leading commercial roles at Synageva BioPharma up to its acquisition by Alexion Pharmaceuticals for $8.4B in 2015, and at Alexion where he launched the blockbuster Soliris for atypical hemolytic uremic syndrome as head of global marketing. Earlier in his career, Dr. Peters served in pipeline planning and commercial roles with increasing responsibility at Merck, Wyeth/Pfizer and Boehringer Ingelheim, spending several years working in Europe, Japan and China. Dr. Peters received his Ph.D. in Biochemistry and M.Sc. in Chemistry (Dipl. Chem.) from Heinrich-Heine University Düsseldorf in Germany.

Catherine Bowes Rickman, Ph.D., FARVO
Dr. Bowes Rickman is a tenured Professor of Ophthalmology and Cell Biology at Duke University. She has a long-standing interest in age-related macular degeneration (AMD) and has become a leader in the development and use of murine models to elucidate the mechanisms of pathology and progression for AMD. She has developed several mouse models that recapitulate many aspects of the human AMD phenotype where she examines the pathogenic contribution of genetic, inflammatory and environmental factors to AMD onset and progression. She has spent the last decade focusing her research on studying the impact of the complement system on the pathobiology of AMD.

[Planopenny]

Should do well today...this is a buy and hold stock for sure.

[conix]

Mustang Bio Provides Updates on its Lentiviral Gene Therapies for the Treatment of X-linked Severe Combined Immunodeficiency (“XSCID”)


FDA removes clinical hold for pivotal Phase 2 MB-107 clinical trial

Company plans to enroll first patient in MB-107 pivotal trial in the second quarter of 2021

Clinical outcomes in investigator-IND XSCID trials continue to show compelling efficacy

WORCESTER, Mass., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today provided updates on MB-107 and MB-207, its lentiviral gene therapies for the treatment of X-linked severe combined immunodeficiency (“XSCID”), also known as bubble boy disease. On January 28, 2021, the U.S. Food and Drug Administration (“FDA”) removed the clinical hold on the MB-107 pivotal Phase 2 clinical trial Investigational New Drug (“IND”) application after reviewing a comprehensive CMC package that was submitted by Mustang in late December 2020. Mustang will proceed with its plans to initiate the pivotal Phase 2 trial in newly diagnosed XSCID patients.

The same lentiviral vector used in MB-107 is currently being assessed in a Phase 1/2 clinical trial for XSCID in newly diagnosed infants under the age of two at St. Jude Children’s Research Hospital (“St. Jude”), UCSF Benioff Children’s Hospital in San Francisco and Seattle Children’s Hospital. Additionally, it is being assessed in a Phase 1/2 clinical trial at the National Institute of Allergy and Infectious Diseases (“NIAID”), part of the National Institutes of Health, for XSCID patients who have been previously treated with hematopoietic stem cell transplantation (“HSCT”) and for whom re-treatment is indicated.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We are pleased to have resolved the clinical hold on the MB-107 IND with the FDA, enabling us to move forward with initiating the pivotal Phase 2 clinical trial. The clinical outcomes observed in XSCID patients in the ongoing Phase 1/2 clinical trials continue to be encouraging. It is especially gratifying to see the consistent safety and efficacy of our lentiviral vector over the course of more than eight years since the first patient was treated at NIAID in 2012. In 2021, we look forward to the anticipated initiation of our pivotal MB-107 and MB-207 clinical trials as we work to bring potential new treatment options for this devastating rare disease to patients and their families.”

MB-107 Update
Data from the Phase 1/2 clinical trial led by St. Jude that were presented at the 61st American Society of Hematology (“ASH”) Annual Meeting in December 2019 included 11 newly diagnosed XSCID patients who had been treated with a median follow-up at data cut-off of 23.6 months (range 1.5 to 33.9 months). No serious adverse events related to treatment were reported other than hematologic ones related to low-dose busulfan conditioning. Nine patients, with a follow up of greater than 3 months, achieved normal-for-age T-cell and natural killer (NK)-cell numbers within 3-4 months post treatment with MB-107. Five patients were off intravenous immunoglobulin (IVIG) therapy, of whom 3 responded to vaccines.

To date, all 11 patients have continued to do well, and 5 additional patients were enrolled at the time of the most recent analysis in early September 2020. At that time, follow-up for these 16 patients ranged from 3 months to 47 months. Similar to previous reports, the therapy continued to be well tolerated in all patients, and stable vector marking was noted in all lineages, with successful engraftment of genetically-modified T-, B-, & NK-cells. All patients cleared pre-existing infections, no new severe infections were noted, and all patients were outpatients. Finally, there was no evidence of malignant transformation at a median follow up of 2 years. Enrollment will continue at all three clinical sites until Mustang initiates its multicenter pivotal Phase 2 trial of MB-107.

In September 2020, The Journal of Allergy and Clinical Immunology: In Practice published a case study of one patient with XSCID and disseminated Bacille Calmette-Guérin (BCG) infection, who was enrolled in the clinical trial at St. Jude. After 2.5 years of treatment, the patient has remained clinically well with a stable, functional immune system and protective vaccine titers, despite the complication of the disseminated BCG infection.

MB-207 Update
The ongoing Phase 1/2 clinical trial being conducted by the NIH is treating older XSCID patients, all of whom had previously received haplo-identical HSCT as infants and were subsequently noted to be experiencing declining immune function with symptomatic infections. At the time of the most recent NIH data presentation at ASH in 2019, 8 patients had been treated without transduction enhancers (referred to as Cohort A) and had been followed for 3 to 7 years. Seven of these 8 patients experienced gradual clinical benefit in terms of clearance of chronic norovirus and associated improved abdominal complaints, malabsorption, growth and IgG production. One of these 7 patients died 27 months after gene therapy of a pulmonary bleed related to chronic bronchiectasis that predated the therapy and was deemed to be unrelated to therapy.

In an attempt to address the relatively slow resolution of chronic norovirus observed in most of these 7 patients and the delayed immune cell recovery and persistent clinical disease in the eighth patient, transduction enhancers were introduced in the cell processing for the subsequent 6 patients (referred to as Cohort B), which included retreatment of the eighth patient in Cohort A who had delayed immune recovery and persistent clinical disease. This enhanced transduction procedure achieved much greater transduction efficiencies than were observed in Cohort A, with greater than 10-fold less vector, and resulted in faster immune reconstitution and more significant clinical benefit by 3 months. As a result, Mustang has licensed Sirion Biotech’s Lentiboost™ and will include transduction enhancement in its pivotal Phase 2 clinical trial for MB-207 in this patient population.

To date, of the 6 Cohort A patients who were alive at the time of the 2019 NIH data readout and who did not undergo repeat therapy, 3 patients have been able to discontinue chronic intravenous immunoglobulin (IVIG) and have experienced sustained restoration of humoral responses to immunization. The remaining 3 patients have had reduced IVIG requirements. All chronic norovirus infections have resolved, and the quality of life of all patients has improved significantly.

The original 6 patients in Cohort B also continue to do well, with longest follow-up now 22 months. Two additional patients have been successfully treated with transduction enhancers, for a total of 8 patients in Cohort B. As was the case in Cohort A, no serious adverse events related to treatment were reported other than hematologic related to low-dose busulfan conditioning, and there was no evidence of malignant transformation. Further enrollment at NIH is now limited pending Mustang’s initiation of its pivotal multicenter Phase 2 clinical trial, and the company expects to submit an Investigational New Drug (“IND”) application for this trial in the second quarter of 2021.

About X-linked Severe Combined Immunodeficiency (“XSCID”)
X-linked severe combined immunodeficiency is a rare genetic disorder that occurs in approximately 1 per 225,000 births. It is characterized by the absence or lack of function of key immune cells, resulting in a severely compromised immune system and death by 1 year of age if untreated. Patients with XSCID have no T-cells or natural killer (NK)-cells. Although their B-cells are normal in number, they are not functional. As a result, XSCID patients are usually affected by severe bacterial, viral or fungal infections early in life and often present with interstitial lung disease, chronic diarrhea and failure to thrive. Among patients who receive HSCT, many are unable to establish adequate T-cell immunity or lose T-cell immunity over time. Further, approximately two-thirds of patients who receive HSCT lack sufficient B-cell immunity and need lifelong immunoglobulin replacement therapy.

The specific genetic disorder that causes XSCID is a mutation in the gene coding for the common gamma chain (?c), a protein that is shared by the receptors for at least six interleukins. These interleukins and their receptors are critical for the development and differentiation of immune cells. The gene coding for ?c is known as IL-2 receptor gamma, or IL2RG. Because IL2RG is located on the X-chromosome, XSCID is inherited in an X-linked recessive pattern, resulting in almost all patients being male.

[Planopenny]

Boing

[Planopenny]

Another nice day here

[conix]

Avenue Therapeutics Announces Publication of Real-World Data on Nonmedical Use of Tramadol in ASI-MV Network

Download as PDFDecember 18, 2020

NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that a publication titled “Real-World Data on Nonmedical Use of Tramadol from Patients Evaluated for Substance Abuse Treatment in the NAVIPPRO Addiction Severity Index?Multimedia Version (ASI-MV®) Network” has been published in Drug Safety, a peer-reviewed international journal covering pharmacoepidemiology and pharmacovigilance. The publication can be accessed here.

“Utilization of real-world data adds significant value to the post market benefit-risk evaluation of prescription opioid medications, because comparative rates of nonmedical use (NMU) between prescription opioid compounds can help providers and patients with pain management decision making, balancing the need for pain therapy with potential risk of NMU,” commented Jody L. Green, Ph.D., the paper’s lead author and Chief Scientific Officer for Inflexxion, a division of Integrated Behavioral Health. “Compared to other common opioid compounds, tramadol had significantly lower rates of NMU, non-oral routes of administration such as snorting or injecting, and diversion, suggesting a lower abuse potential.”

The objective of the study was to evaluate nonmedical use (NMU) and diversion of tramadol and comparator opioids (morphine, oxycodone, and hydrocodone) using real-world data from the Addiction Severity Index?Multimedia Version (ASI-MV®). A cross-sectional study design was used to evaluate past 30-day tramadol and comparator opioid NMU among adults assessed for substance abuse treatment using the ASI-MV from 2010-2018. The paper concluded that tramadol had a significantly lower rate of NMU than comparator opioids and was less likely to be diverted or used via higher-risk non-oral routes, and that these findings support previous evaluations by WHO and the United States Drug Enforcement Agency that concluded that tramadol has a low potential for abuse.

About Avenue Therapeutics

Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com.

About Inflexxion and Integrated Behavioral Health

Inflexxion joined the Integrated Behavioral Health (IBH) family of companies in July 2018. Inflexxion is a healthcare data and analytics company that specializes in the collection, surveillance, monitoring and analysis of critical public health issues including prescription drug abuse, substance use, behavioral health, and pain management. With over 30 years in the industry, Inflexxion works with healthcare organizations, medical professionals, pharmaceutical companies, and regulatory authorities to assess, track and improve patient care and inform public policy. Inflexxion collects, analyzes and disseminates extensive behavior and health-related data for pharmaceutical post-market surveillance, risk management, epidemiological studies, product improvements, abuse prevention and outcome measurement.

About Addiction Severity Index?Multimedia Version (ASI-MV)
The ASI-MV is a comprehensive, evidence-based, patient self-administered assessment tool. Based on the widely used Addiction Severity Index (ASI), the ASI-MV provides clinical information, severity ratings and composite scores in seven life domains: medical; employment; alcohol; drug; legal; family/social; and psychological. Behavioral health professionals use the ASI-MV to conduct standardized, thorough, and efficient substance-use assessments and to gather real-time data on client outcomes.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Contacts:

Jaclyn Jaffe and William Begien
Avenue Therapeutics, Inc.
[phone]
[e-mail]

[KingOfSwing...Trading]

Looks like something is brewing overnight. Anxious for tomorrow.

[Paullee]

Fortress Biotech Announces Breakthrough Therapy Designation for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease
Fortress Biotech, Inc.
Tue, December 15, 2020, 8:00 AM EST
Rolling submission of New Drug Application to the FDA for CUTX-101 on track to begin in the first quarter of 2021 and to be completed by the end of the second quarter of 2021

NEW YORK, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative revenue-generating company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Therapy Designation to Cyprium Therapeutics (“Cyprium”) for CUTX-101, a potential treatment for Menkes disease. Often lethal if untreated, Menkes disease is an X-linked recessive disorder of copper metabolism caused by mutations in ATP7A, an evolutionarily conserved copper-transporting ATPase. The FDA previously granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations to CUTX-101 for the treatment of Menkes disease. Additionally, the European Medicines Agency previously granted Orphan Drug Designation to CUTX-101.

“We are very pleased that the FDA has granted Breakthrough Therapy Designation to CUTX-101, a devastating pediatric disease with no FDA-approved treatment options currently available. The positive topline clinical efficacy data reported earlier this year highlight the potential of CUTX-101 to be a safe and effective therapy and fulfill a significant unmet medical need for patients with Menkes disease. We look forward to beginning our rolling submission of a New Drug Application (“NDA”) to the FDA for CUTX-101 in the first quarter of next year. Our goal is to bring this treatment to patients as soon as possible,” said Lung S. Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium.

Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A Breakthrough Therapy Designation conveys all of the fast-track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers and eligibility for rolling review and priority review.

About Menkes Disease and Related Copper Metabolism Disorders
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of copper transporter ATP7A. The minimum birth prevalence for Menkes disease is believed to be 1 in 34,810 males, and potentially as high as 1 in 8,664 live male births, based on recent genome-based ascertainment (Kaler SG, Ferreira CR, Yam LS. Estimated birth prevalence of Menkes disease and ATP7A-related disorders based on the Genome Aggregation Database (gnomAD). Mol Genet Metab Rep. 2020 Jun 5;24:100602). Biochemically, patients with Menkes disease have low levels of copper in their blood and brain, as well as abnormal levels of certain neurochemicals. Definitive diagnosis is made by sequencing the ATP7A gene. The condition is characterized by distinctive clinical features, including sparse and depigmented hair (“kinky hair”), connective tissue problems, and severe neurological symptoms such as seizures, hypotonia, failure to thrive, and neurodevelopmental delays. Mortality is high in untreated Menkes disease, with many patients dying before the age of three years. Milder versions of ATP7A mutations are associated with other conditions, including Occipital Horn Syndrome and ATP7A-related Distal Motor Neuropathy. Currently, there is no FDA-approved treatment for Menkes disease and its variants.

About CUTX-101 (Copper Histidinate)
CUTX-101 is in clinical development to treat patients with Menkes disease by replenishing Copper Histidinate, restoring copper homeostasis and maintaining serum copper levels in the normal age appropriate range. CUTX-101 is a subcutaneous injectable formulation of Copper Histidinate manufactured under current good manufacturing practice (“cGMP”) and physiological pH that bypasses the defect in absorption of orally administered copper in patients with Menkes disease. In a Phase 1/2 clinical trial conducted by Stephen G. Kaler, M.D., M.P.H., at the National Institutes of Health (“NIH”), early treatment of patients with Menkes disease with CUTX-101 led to an improvement in neurodevelopmental outcomes and survival. A Phase 3 trial of CUTX-101 in patients with Menkes disease also led by Dr. Kaler has completed enrollment. In August 2020, Cyprium reported positive topline clinical efficacy results for CUTX-101, demonstrating statistically significant improvement in overall survival for Menkes disease subjects who received early treatment (ET) with CUTX-101, compared to an untreated historical control (HC) cohort, with a nearly 80% reduction in the risk of death. A Cyprium-sponsored expanded access protocol for patients with Menkes disease is ongoing at Nationwide Children’s Hospital (https://www.nationwidechildrens.org/specialties/menkes-disease-clinic) and other US medical centers.

About Cyprium Therapeutics
Cyprium Therapeutics, Inc. (“Cyprium”) is focused on the development of novel therapies for the treatment of Menkes disease and related copper metabolism disorders. In March 2017, Cyprium entered into a Cooperative Research and Development Agreement (“CRADA”) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), part of the NIH, to advance the clinical development of CUTX-101 (Copper Histidinate injection) for the treatment of Menkes disease. In addition, Cyprium and NICHD entered into a worldwide, exclusive license agreement to develop and commercialize adeno-associated virus (AAV)-based gene therapy, called AAV-ATP7A, to deliver working copies of the copper transporter that is defective in patients with Menkes disease, and to be used in combination with CUTX-101. CUTX-101 was granted FDA Fast Track and Rare Pediatric Disease Designations, and both CUTX-101 and AAV-ATP7A have received FDA Orphan Drug Designation previously. Additionally, the European Medicines Agency previously granted Orphan Drug Designation to CUTX-101. Cyprium was founded by Fortress Biotech, Inc. (Nasdaq: FBIO) and is based in New York City. For more information, visit www.cypriumtx.com.

[conix]

Serious charges and potentially expensive if proven.

[KingOfSwing...Trading]

Yes, that is the one I was referring to

[conix]

On November 27, 2020, a class action lawsuit was filed against Fortress Biotech in United States District Court, Eastern District of New York.

According to the class action complaint, throughout the Class Period, the Fortress Biotech Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, according to the class action complaint, the Fortress Biotech Defendants made false and/or misleading statements and/or failed to disclose that IV Tramadol was not safe for the intended patient population, and that it was foreseeable to them that the FDA would not approve the New Drug Application for IV Tramadol.

[KingOfSwing...Trading]

Did you see the article regarding the class action lawsuit last Friday?

[Rafa636]

You're smarter than I am....lol, I always swing for the fences!

[conix]

I have seen no updates on the Tramadol delay. The problem with biotech are the potential for negative surprises.

The positive surprises are always fun.

I try to take some profits before news...in case there is a negative surprise.

[Rafa636]

Thanks conix, I am still surprised how badly the Tramadol delay hurt the stock? They have so many other real good potentials in the pipeline to see it drop so much was very surprising. I haven't seen any follow ups on the delay since it came out?

[conix]

Fortress Biotech Ranked in Deloitte’s Technology Fast 500™ for the Second Year in a Row


NEW YORK, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative revenue-generating company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, today announced that it ranked number 135 in Deloitte’s 2020 Technology Fast 500™, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors. Fortress’ 874 percent revenue growth based on the increase in net product sales from 2016 to 2019 secured its spot in the rankings.

“We are thrilled to be recognized among an elite group of 500 companies in Deloitte’s Technology Fast 500™ for the second year in a row. We are proud of our rapid revenue growth, as generating value for our shareholders is always a top priority,” said Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer. “Our business strategy allows us to acquire and develop a broad array of new marketed products and product candidates with significant commercial and clinical potential. Through our approach, we have established a growing portfolio of five marketed products and over 25 development-stage programs that we believe will provide our company and its shareholders with a diversified long-term revenue stream.”

Now in its 26th year, the Technology Fast 500 selects companies based on percentage fiscal year revenue growth over a three-year period. Overall, the 2020 Technology Fast 500 companies achieved revenue growth ranging from 175 percent to 106,508 percent from 2016 to 2019, with a median growth rate of 450 percent. For more information about the Technology Fast 500, visit www.fast500.com.

[Rafa636]

Thanks conix, Nice PR but it hasn't had any positive effects on FBIO. The Avenue Therapeutics Tramadol bad news really hurt the stock as is a legal case brought to see if there was any insider shenanigans. Hoping to see this stock in the $6.00 to $8.00 range on further good news???

[conix]

Mustang Bio Reports Third Quarter 2020 Financial Results and Recent Corporate Highlights

November 06, 2020

WORCESTER, Mass., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2020.

“Mustang had an eventful third quarter on the regulatory front, as the U.S. Food and Drug Administration (“FDA”) granted Rare Pediatric and Orphan Drug Designations to both of our gene therapy product candidates for the treatment of X-linked severe combined immunodeficiency (“XSCID”), MB-107, for newly diagnosed infants, and MB-207, for patients previously treated with hematopoietic stem cell transplantation (“HSCT”) and for whom re-treatment is indicated,” said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang.

Dr. Litchman continued, “We are also pleased to report progress across our CAR T cell therapy programs during the third quarter and subsequent period. Most importantly, as recently reported, we have observed compelling efficacy without CAR T related toxicity in the first 4 non-Hodgkin lymphoma patients treated with MB-106, a CD20-targeted CAR T cell therapy, following a major revision in the cell manufacturing process at the Fred Hutch Cancer Research Center (“Fred Hutch”). We also dosed the first patient in a Phase 1/2 clinical trial of MB-102, a CD123-targeted CAR T cell therapy, under our own Investigational New Drug (“IND”) application for relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, acute myeloid leukemia and high-risk myelodysplastic syndrome. Finally, we are encouraged by the significant response to MB-105, a prostate stem cell antigen (“PSCA”)-targeted CAR T therapy, reported by City of Hope in a 73-year-old patient with PSCA-positive metastatic castrate-resistant prostate cancer. This patient, who had failed eight prior therapies, experienced a 94 percent reduction in prostate-specific antigen, with a near complete reduction of measurable soft tissue metastasis by computerized tomography and improvement in bone metastases by magnetic resonance imaging. We look forward to achieving additional milestones in the coming months, as we expect to disclose additional promising clinical data from our MB-106 program at the American Society of Hematology (“ASH”) Annual Meeting next month. In addition, next quarter we expect to enroll the first patient on our pivotal MB-107 lentiviral gene therapy trial for newly diagnosed infants with XSCID and to file an IND for our pivotal MB-207 lentiviral gene therapy trial for previously transplanted patients with XSCID.”

Recent Corporate Highlights:

In August 2020, Mustang announced that the FDA granted Rare Pediatric Disease Designation to MB-107, a lentiviral gene therapy for the treatment of XSCID, also known as bubble boy disease, in newly diagnosed infants and to MB-207, a lentiviral gene therapy for the treatment of patients with XSCID who have been previously treated with HSCT and for whom re-treatment is indicated.
In September 2020, the FDA granted Orphan Drug Designation to MB-107 for the treatment of XSCID in newly diagnosed infants and to MB-207 for the treatment of patients with XSCID who have been previously treated with HSCT and for whom re-treatment is indicated.
In October 2020, Mustang announced that the first patient had been dosed in a company-sponsored, open label, multicenter Phase 1/2 clinical trial to evaluate the safety and efficacy of MB-102 (CD123-targeted CAR T cell therapy) in patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (hrMDS).
In October 2020, Mustang licensed LentiBOOST™ technology from SIRION Biotech GmbH for the development of MB-207.
In October 2020, City of Hope presented initial Phase 1 data on MB-105, a PSCA-targeted CAR T administered systemically to patients with PSCA-positive mCRPC, at the virtual 27th Annual Prostate Cancer Foundation Scientific Retreat.
Earlier this month, Mustang announced that interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas, were selected for a poster presentation at the 62nd ASH Annual Meeting. A link to the abstract can be found here.

Financial Results:

As of September 30, 2020, the company’s cash, cash equivalents and restricted cash totaled $76.3 million, compared to $86.4 million as of June 30, 2020, and $62.4 million as of December 31, 2019.
Research and development expenses were $8.0 million for the third quarter of 2020. This compares to $7.3 million for the third quarter of 2019. Non-cash, stock-based compensation expenses included in research and development were $0.3 million for the third quarter of 2020, compared to $0.7 million for the third quarter of 2019.
Research and development expenses from license acquisitions totaled $0.3 million for the third quarter of 2020, compared to $0.7 million for the third quarter of 2019.
General and administrative expenses were $2.2 million for the third quarter of 2020. This compares to $2.0 million for the third quarter of 2019. Non-cash, stock-based compensation expenses included in general and administrative expenses were $0.3 million for the third quarter of 2020, compared to $0.4 million for the third quarter of 2019.
Net loss attributable to common stockholders was $13.0 million, or $0.23 per share, for the third quarter of 2020, compared to a net loss attributable to common stockholders of $10.2 million, or $0.25 per share, for the third quarter of 2019.

About Mustang Bio

Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for XSCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.mustangbio.com.

[Rafa636]

It still has a few strong buy ratings. There hasn't been any follow up regarding the Tramadol letter? I would of assumed we would of heard something by now but nothing, Hopefully this movement up today is a positive sign of things to come??

[Porterhouse10]

Not sure but looking at the chart, and it consolidating here a bit, any vood/ positive news could send it north, risk/reward starring you in the face right here. Jmo, but watching

[Rafa636]

Anybody know what's going on with the Tramadol inquiry? Still lots of selling pressure from the MMs. FBIO still has a few strong buy ratings but has had over a week of selling??

[Porterhouse10]

Ok, my avg is 3.98 so not too far off, I'll wait and see how she does

[Planopenny]

Its back...im out. Too scary

[Planopenny]

No idea...my trade went through now I cant trade. Uhhh maybe oops

[Porterhouse10]

Is it halted? Cant trade

[Planopenny]

Grabbed some 3’s. Selling them at 3.50

[Planopenny]

Oh no...

[Porterhouse10]

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