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author：comprehensive 2025-09-27 10:05:16 - browse：75

Amylyx founders — Justin Klee, left, and Joshua Cohen, both co-founders and co-CEO's of Amylyx Pharmaceuticals. Kayana Szymczak for STAT

The Food and Drug Administration has reversed an internal decision and will now review an experimental treatment for amyotrophic lateral sclerosis — a victory for ALS patients and advocates who have been pressuring regulators to act with more urgency against the fatal, neurodegenerative disease.

Amylyx Pharmaceuticals, a Cambridge, Mass.-based drug maker, said Wednesday that it will submit an application for its ALS treatment, called AMX0035, “in the coming months.”

The filing will be based largely on a single clinical trial of AMX0035 completed one year ago that showed a significant slowing of disease progression in patients with ALS. It’s the same study that FDA officials told Amylyx last April was encouraging, but not convincing enough to review for approval on its own. The company was told by FDA staff to conduct another study, gather more positive data, and then file for approval.

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