Amylyx Pharmaceuticals
NEWS
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
The biopharma world - and markets - spent Thursday evening reacting after the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s Relyvrio.
The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
The FDA provided briefing documents ahead of Amylyx’s rare second adcomm for AMX0035, an investigational treatment for ALS. The regulator does not appear to be convinced.
BrainStorm Cell Therapeutics said it will submit a Biologics License Application to the FDA for ALS hopeful NurOwn. Additionally, a correction has been made to analyses of the Phase III clinical trial.
The FDA has had a busy week, accepting drug applications, approving clinical trials and granting various special designations for Gamida Cell, Cellectis, Scynexis & more.
Clene, Inc. released data that shows its add-on treatment, CNM-Au8, significantly improved survival in patients with amyotrophic lateral sclerosis (ALS) by 70%.
As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.
The approval of AMX0035, which will be marketed under the brand name Albrioza, marks the first new ALS drug approved in Canada since 2018.
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