The whopper deal between Biogen Inc. and Sage Therapeutics Inc. – a global collaboration and licensing deal involving the latter’s zuranolone (also known as SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders, as well as SAGE-324 for essential tremor (ET) and neurological disorders – drew mixed reviews from Wall Street. And, for Biogen investors, the would-be Alzheimer’s disease (AD) therapy aducanumab remains front of mind.
Talk turned skeptical well before lunchtime in the meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee to consider Biogen Inc.’s aducanumab for Alzheimer’s disease, and it stayed that way until the end, when panelists voted thumbs down.
The FDA posted briefing documents related to the Nov. 6 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, and Wall Street’s opinion turned out decidedly mixed regarding the odds for aducanumab, the anti-amyloid beta monoclonal antibody for Alzheimer’s disease from Cambridge, Mass.-based Biogen Inc. and Eisai Co. Ltd., of Tokyo.
The dramatic increase in COVID-19 infections in Europe and the U.S., combined with information overload surrounding the lead up to the Nov. 3 contentious U.S. presidential election, was more than enough to send investors to the sidelines in October.
The latest global regulatory news, changes and updates affecting biopharma, including: NIH lays out final policy on data sharing; NICE to review Spinraza data; Olinvyk a Schedule II; FDA issues REMS MAPP.
Two complete response letters for group members dispatched this month by the FDA was enough to contribute to a flat performance in October for the BioWorld Neurological Diseases index. Overall, the price-weighted index has remained underwater for most of the year with its value down about 5% during this period.
With a Nov. 6 FDA adcom meeting on Biogen Inc.'s Alzheimer's candidate, aducanumab, creeping ever closer, the candidate's prospects stole the show in its third-quarter earnings report, even outshining attention to the cloud of generics raining on the company's years-long Tecfidera (dimethyl fumarate) parade. FDA acceptance for aducanumab's BLA lines the candidate up for a priority review and regulatory action by March 7, the company said. Furthermore, global progress remains underway, with an EU marketing application now made and one in Japan on deck.
Scribe Therapeutics Inc., another CRISPR-based genome editing firm out of the Jennifer Doudna stable, launched with $20 million in series A funding and a deal with Biogen Inc. in amyotrophic lateral sclerosis (ALS), which brings in another $15 million up front and up to $400 million in development and commercial milestones.
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz.