Amylyx Pharmaceuticals
NEWS
A meeting with an amyotrophic lateral sclerosis (ALS) patient in Israel who could only speak with the assistance of a computer changed the life and direction of NeuroSense CEO Alon Ben-Noon.
Data from Clene’s RESCUE-ALS trial showed that treatment with CNM-Au8 significantly slowed progression of ALS and improved quality of life.
Lately, there has been heightened attention to briefing documents in the CNS space, a notoriously tricky area to get drugs approved, which can affect company stock prices.
The FDA released materials for review ahead of Wednesday’s meeting and it appears to paint a picture of insufficient data for approval, noting it is “not exceptionally persuasive.”
Biogen and Ionis Pharmaceuticals announced that their Phase I study of BIIB078 (IONIS-C9Rx) intended for ALS did not meet clinical endpoints, so they will discontinue the program.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will face its first big test since Aduhelm as it weighs the merits of Amylyx’s AMX0035 for ALS on Wednesday, March 30.
The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
The FDA will evaluate AMX0035, an investigational oral fixed-dose drug intended for people diagnosed with ALS.
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