Amylyx shares soar 70% after FDA panel backs ALS drug

ALS

08/09/2022 12:52

Sept 8 (Reuters) - Shares of Amylyx Pharmaceuticals  AMLX.O 
jumped 70% on Thursday after a panel of advisers to the U.S.
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.     
    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.
 urn:newsml:reuters.com:*:nL4N30E40K
    "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)
 ((Leroy.Dsouza@thomsonreuters.com ; Twitter: https://twitter.com/LeroyLeo7;))