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The company reached a manufacturing agreement with Bachem Americas and a term sheet with Polypeptide Group to lock in long-term commercial supply of avexitide starting in 2028.
SEC filing
The company expects roughly $471.7 million in net proceeds to fund a potential avexitide launch in post-bariatric hypoglycemia, with an NDA planned by year-end 2026.
SEC filing (2)
The company expects net proceeds of about $471.7 million to help fund a potential U.S. launch of avexitide.
SEC filing
The LUCIDITY trial hit its primary endpoint with a 55% reduction in hypoglycemic events, and Amylyx plans to file for FDA approval by year-end.
SEC filing (2)
Amylyx said the last participant finished the 16-week double-blind portion of the Phase 3 avexitide trial in post-bariatric hypoglycemia, with cash runway into 2028.
SEC filing