The U.S. Food and Drug Administration (FDA) has extended the review of New Drug Application (NDA) by three months, submitted by Amylyx Pharmaceuticals AMLX for its lead drug candidate AMX0035 with regard to the treatment of patients with amyotrophic lateral sclerosis (ALS).
The regulatory agency has assigned Standard Review for the application and set a new PDUFA target action date of 29th September 2022.
The New Drug Application (NDA) was supported by CENTAUR Phase 2 clinical trial evaluated AMX0035 in 137 participants with ALS.
The FDA extended the goal date to allow more time to review additional analyses of data from the Company's clinical studies.
Justin Klee and Joshua Cohen, Co-CEOs and Co-Founders, commented : "We are confident in the potential of AMX0035 to help people living with ALS and other neurodegenerative diseases, and we continue to work closely with the FDA as they complete their review".
Amylyx Pharmaceuticals shares are currently trading at $11.80, up 21 percent in the pre-market session, compared with the previous day closing price of $8.55.
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