- The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted (7 yes and 2 no) that the available evidence of effectiveness is sufficient to support the approval of Amylyx Pharmaceuticals Inc’s (NASDAQ:AMLX) AMX0035 for amyotrophic lateral sclerosis (ALS), just months after voting against the drug in a first adcomm.
- The committee had previously voted against AMX0035 in March, deciding that the single randomized Centaur trial was not robust enough to prove efficacy, despite meeting its primary endpoint.
- Related: FDA Again Highlights Lacking Data From Amylyx’s Amyotrophic Lateral Sclerosis Candidate.
- Amylyx also presented a post-hoc analysis comparing patients’ progression in the AMX0035 group to their progression rates before the study and biomarker data from an Alzheimer’s study to show the drug’s effects on neurodegeneration.
- Canada granted AMX0035 a conditional approval earlier this year, contingent upon a successful Phase 3 study.
- AMX0035’s PDUFA date is September 29.
- Citigroup maintains Buy on Amylyx Pharma, raising the price target to $48 from $35.
- Price Action: AMLX shares are up 63.20% at $29.22 on the last check Thursday.
Live-Action “The Legend Of Zelda” Movie Announced By Nintendo And Sony Pictures
A live-action adaptation of the iconic video game "The Legend of Zelda" is in development, as announced by Nintendo.
