June’s PDUFA dates no longer include Amylyx’s ALS therapy

With Amylyx’s announcement Friday that the PDUFA date for its ALS therapy has been delayed until Sep. 29, seven therapies remain with disclosed goal dates in June. Three are under priority review and two would be the manufacturers’ first marketed drug.

The prospects of amyotrophic lateral sclerosis candidate AMX0035 from Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) appeared shaky after a March 30 meeting of FDA’s Peripheral and Central Nervous System Drug advisory committee, in which the committee voted 6-4 against the effectiveness of the candidate, despite loud calls from patient groups to approve the therapy. In the meeting, FDA argued against the robustness of Amylyx’s data...