Amylyx’s Experimental ALS Drug Nabs FDA Priority Review

Amylyx Pharmaceuticals has scored a priority review by the FDA for AMX0035 (sodium phenylbutyrate and taurursodiol) as a treatment for amyotrophic lateral sclerosis (ALS).

If approved, AMX0035 would be the first new ALS drug since 2019.

The company got the good news after an FDA review of new data to support the company’s New Drug Application (NDA), which the agency requested in September.

Based on positive phase 2 data from the CENTAUR trial, the FDA has accepted the NDA for a priority review, with a Prescription Drug User Fee Act decision date of June 29, 2022.