StemCell Therapy

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimers drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agencys decision-making time to a mere 6 months.

The news drove a 10% spike in Biogens stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Flagship execs take a lesson from nature to master 'gene writing,' launching a star-studded biotech with big ambitions to cure disease - Endpoints...

This entry was posted on July 10, 2020 at 7:46 am and is filed under Gene therapy. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |