Monday, September 25

Amylyx shares soar 70% after FDA panel backs ALS drug

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Shares of Amylyx Pharmaceuticals jumped 70% on Thursday after a panel of advisers to the US Food and Drug Administration voted in favor of the company’s treatment for a fatal neurodegenerative condition.

The second meeting for the amyotrophic lateral sclerosis (ALS) oral drug was more positive than expected, with the agency appearing amenable to regulatory flexibility for ALS, brokerage SVB Securities said.

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The 7-to-2 vote on Wednesday in favor of the drug, which came months after the FDA panel rejected it over issues with trial data in March, was a rare turnaround for the company.

“We had always thought that the FDA wanted to approve the product, and now we strongly believe that this is the case,” SVB securities said. The agency will decide on the drug by Sept. 29.

ALS, whose cause is largely unknown, breaks down nerve cells in the brain and the spinal cord.

Amylyx shares, up at $30.96 before the bell on Thursday, have lost 28% since March when the FDA panel voted against the drug.

(Reporting by Leroy Leo in Bengaluru; Editing by Vinay Dwivedi)