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Amylyx shares surge after Phase 3 avexitide data for post-bariatric hypoglycemia
The Lucidity Phase 3 trial in 78 participants showed a 55% reduction in hypoglycemic events, and Amylyx plans to submit an NDA by the end of 2026.
Amylyx (AMLX) shares jumped sharply after the company reported promising late-stage results for its GLP-1 receptor antagonist avexitide, according to Yahoo Finance. In the Lucidity Phase 3 trial, Amylyx said avexitide produced a 55% reduction in hypoglycemic events for post-bariatric hypoglycemia patients, alongside meeting a primary FDA-agreed composite endpoint and all secondary endpoints. The study involved 78 participants, and Amylyx described the results as a milestone because there are currently no FDA-approved treatments for post-bariatric hypoglycemia. The drug candidate also holds Breakthrough Therapy and Orphan Drug designations. Amylyx said it plans to submit a new drug application by the end of 2026, targeting a commercial launch next year. The company projected a multi-year cash runway extending into 2028, and said the Phase 3 trial maintained a clean safety profile.