regulatory
confidence high
sentiment neutral
materiality 0.70
FDA plans to reconvene advisory committee for Amylyx's ALS drug AMX0035 on Sept 7
Amylyx Pharmaceuticals, Inc.
- FDA to reconvene PCNSDAC on September 7, 2022 to discuss AMX0035 NDA for ALS.
- Discussions will focus on additional analyses of clinical data deemed a major amendment to the NDA.
- PDUFA target action date extended to September 29, 2022 from June 29, 2022 for FDA review.
- Advisory committee previously met March 30, 2022; new meeting signals continued FDA scrutiny.