11thestate
Oct 1, 1:30 PM
Amylyx Pharmaceuticals (
$AMLX) Is Moving Toward an FDA Filing After Positive Phase 3 Results
Amylyx reported positive Phase 3 results for avexitide, an investigational treatment for post-bariatric hypoglycemia. The trial showed a 55% reduction in hypoglycemic events compared with placebo, while also meeting all secondary endpoints. https://www.amylyx.com/news
The company now plans to submit an NDA to the FDA by the end of 2026, with a potential commercial launch in 2027 if approved. Avexitide has also received FDA Breakthrough Therapy and Orphan Drug designations. https://investors.amylyx.com/news-releases/news-release-details/amylyx-pharmaceuticals-announces-positive-topline-results-0
Amylyx has also raised approximately
$500M to support development and potential commercialization, and recently entered manufacturing agreements to support future avexitide supply if approved.
The news comes after Relyvrio was withdrawn in 2024 following a failed Phase 3 trial, which also led to a
$6.5M investor settlement. https://11th.com/cases/amylyx-pharmaceutical-investor-settlement
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