Four Major Approval Decisions To Watch Out For In Q2

19 Apr 2022

• By Ayisha Sharma

Having looked at four prominent drug candidates which are expecting important top-line data this quarter, with the help of Biomedtracker's Q2 Outlook Report, we take a look at four other assets that could soon break into the US market, from infectious diseases to diabetes.

Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medication. — These Four Drug Candidates Have A PDUFA Date Set By The FDA • Source: Alamy

Amylyx Pharmaceuticals, Inc.’s AMX0035 for the rare neurodegenerative disorder amyotrophic lateral sclerosis (ALS) is set for a US Food and Drug Administration decision on 29 June. The candidate is a proprietary combination of tauroursodeoxycholic acid and sodium phenylbutyrate designed to reduce mitochondrial and endoplasmic reticulum stress.

The filing was based on data from the pivotal CENTAUR trial, which enrolled 137 ALS patients and measured the co-primary...