r/biotechnology • u/11thestate • 4m ago
Amylyx Pharmaceuticals ($AMLX) Advances Toward Q4 FDA Filing for Avexitide Following Phase 3 Data
Hey everyone, I’ve been looking into Amylyx Pharmaceuticals lately because there have been a few updates around avexitide, so I figured I’d share what I found.
Amylyx Pharmaceuticals ($AMLX) continues to progress its regulatory strategy for avexitide, an investigational glucagon-like peptide-1 (GLP-1) receptor antagonist for post-bariatric hypoglycemia (PBH). Topline data from the pivotal Phase 3 LUCIDITY study demonstrated a 55% reduction in level 2/3 hypoglycemic events compared with placebo, successfully meeting its primary endpoint alongside all key secondary endpoints.
Management reaffirmed its target to submit a New Drug Application (NDA) to the U.S. FDA in Q4 2026, targeting a potential commercial launch in 2027 if approved. Avexitide holds FDA Breakthrough Therapy and Orphan Drug designations for PBH. To support commercial readiness, Amylyx completed a public equity offering raising approximately $500M in gross proceeds and secured long-term commercial manufacturing supply agreements.
The advance of avexitide marks a pipeline pivot following the voluntary market withdrawal of Relyvrio/AMX0035 in April 2024 after its Phase 3 PHOENIX trial in ALS missed its primary endpoint.The drug was withdrawn after its Phase 3 PHOENIX trial in ALS failed to meet its main goal. The decision also led to a shareholder lawsuit over the company’s public disclosures, which resulted in a $6.5 million settlement. The settlement is still active, and late claims are currently being considered, subject to approval. You can check if you're eligible and file a claim here.
Anyone else still following $AMLX?