Amylyx Pharmaceuticals
NEWS
Amylyx Pharmaceuticals shared news that the FDA has extended the review period for AMX0035, a combination drug treatment with the potential to treat patients with ALS.
In honor of ALS Awareness Month, BioSpace spoke with leading researchers like Dr. Matthew Harms of Columbia University and Drs. Howard Berman and Stanley Appel at Coya Therapeutics.
A post hoc analysis of data from the Phase II CENTAUR study showed a 10.6-month longer median survival duration for AMX0035 participants, Amylyx announced Thursday.
In a meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, six members voted not to approve the NDA for Amylyx’s ALS candidate, AMX0035, while four voted in favor.
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.
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