Amylyx Pharmaceuticals shares surged more than 45% on Tuesday after the company reported topline results from its pivotal Phase 3 LUCIDITY trial.
The 78-patient study evaluated avexitide, a first-in-class GLP-1 receptor antagonist, in patients with post-bariatric hypoglycemia. The trial met its primary endpoint with strong statistical significance (p=0.000003), demonstrating a 55% reduction in moderate-to-severe hypoglycemic events compared to placebo over 16 weeks. There are currently no FDA-approved treatments for the condition, which affects roughly 160,000 Americans and can cause cognitive impairment, loss of consciousness, or seizures.
Stifel analyst James Condulis called the reduction a best-case scenario, while TD Cowen projects peak U.S. sales of $2.2 billion. Amylyx plans to submit a New Drug Application by year-end, targeting a potential 2027 commercial launch. The company also announced a $350 million underwritten public stock offering to fund pre-commercial activities. The rally marks a recovery after Amylyx withdrew its ALS drug Relyvrio from the market in 2024 following a late-stage failure. Amylyx acquired avexitide from Eiger BioPharmaceuticals for $35.1 million in 2024 during Eiger's bankruptcy auction.
