FDA Decision On BMY’s Drug Postponed, ENTA’s PBC Study Fails, MGNX Turns Heads

Today’s Daily Dose brings you news about the revised FDA decision date for Bristol Myers’ CAR T cell therapy for refractory large B-cell lymphoma; Enanta Pharma’s primary biliary cholangitis trial results; MacroGenics’ anticipated clinical data read-outs and regulatory event for this year and Trovagene’s name change.

Read on…

The FDA decision on Bristol Myers Squibb’s (BMY) investigational CAR T cell therapy Lisocabtagene maraleucel (liso-cel) has been postponed by three months and is now expected on November 16, 2020.

The Company is seeking approval of Lisocabtagene maraleucel for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies.

Lisocabtagene maraleucel came under Bristol Myers’ fold following the acquisition of Celgene last year.

The FDA approval of Lisocabtagene maraleucel by December 31, 2020, is one of the required remaining milestones of the Contingent Value Rights issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other is the regulatory approval of Idecabtagene Vicleucel (ide-cel) in the U.S. by March 31, 2021.

BMY closed Wednesday’s trading at $61.13, down 0.37%.

Enanta Pharmaceuticals Inc.’s (ENTA) phase II study of EDP-305 in subjects with primary biliary cholangitis, dubbed INTREPID, has not met the primary endpoint, as defined by at least a 20% reduction in alkaline phosphatase, or ALP, from pre-treatment value at week 12.

Primary biliary cholangitis is a chronic liver disease.

Even though the study failed to meet the primary endpoint, there were numerically higher response rates with both the 1 mg and 2.5 mg dosages of EDP-305 compared to placebo, according to the Company.

Jay Luly, President and Chief Executive Officer of Enanta said, “Rather than conducting further dose selection studies with EDP-305 in primary biliary cholangitis, a disease for which there is already an approved second-line FXR agonist therapy, we intend to focus our future efforts with EDP-305 on NASH, a disease where FXR agonists like EDP-305 have the potential to be important components of drug combinations designed to give maximum benefit to patients”.

ENTA closed Wednesday’s trading at $51.67, up 1.35%.

Shares of MacroGenics Inc. (MGNX) soared more than 230 percent on Wednesday, following an update on its anticipated clinical data read-outs and regulatory event for this year.

The Company’s lead drug candidate is Margetuximab, under phase III trial in patients with HER2-positive metastatic breast cancer who have previously been treated with anti-HER2-targeted therapies, dubbed SOPHIA.

The study has already met its primary endpoint of prolongation of progression-free survival, the results of which were announced last year. The data from the final overall survival (OS) analysis of the SOPHIA study of Margetuximab are expected to be presented in the second half of this year.

A phase II/III study of Margetuximab plus and Retifanlimab as a front-line treatment for advanced gastric and gastroesophageal junction cancer, dubbed MAHOGANY, is underway, with initial data anticipated in the second half of 2020.

Cash, cash equivalents, and marketable securities as of March 31, 2020, were $170.8 million.

MGNX closed Wednesday’s trading at $25.15, up 230.92%.

Trovagene Inc. (TROV) will have a new corporate name and ticker symbol, beginning May 8, 2020.

The name will be changed to Cardiff Oncology Inc., and ticker symbol to CRDF, to reflect the Company’s mission and commitment to turning the tide on cancer with its development of Onvansertib, a first-in-class, third-generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, for the treatment of cancers representing the greatest need for new effective treatment options.

Mark Erlander, who has served as Chief Scientific Officer since joining the Company in 2013, will assume the role of Chief Executive Officer.

Thomas Adams, Chairman of the Board since 2009, and CEO since June of 2018 will transition his role to Executive Chairman, and continue to provide his strategic guidance and drug development expertise to the Company, as per a statement released on Wednesday.

TROV closed Wednesday’s trading at $1.20, down 2.44%.

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