Amylyx Pharmaceuticals Inc. surged 49% in midday trading Tuesday after its experimental drug avexitide met all primary and secondary endpoints in a Phase 3 trial for post-bariatric hypoglycemia, sending the stock to a new 52-week high of $32.81.
The trial, known as LUCIDITY, enrolled 78 participants in a multicenter, randomized, double-blind, placebo-controlled study. Avexitide demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared with placebo, with a p-value of 0.000003. All secondary endpoints were also met, showing clinically meaningful reductions in hypoglycemic burden. The drug was reported to be generally well-tolerated with a favorable safety profile.
Mizuho analyst Graig Suvannavejh raised his price target on Amylyx to $30 from $24, maintaining an Outperform rating and designating the stock a top pick ahead of the data release. The upgrade reflects higher assumed launch pricing for avexitide.
Amylyx plans to submit a New Drug Application to the FDA by the end of 2026, with a potential commercial launch in 2027. The drug candidate holds FDA Breakthrough Therapy and Orphan Drug designations for post-bariatric hypoglycemia, a condition currently lacking approved treatment options.
The rally occurred as broader equities declined: the S&P 500 fell 0.5%, the Dow Jones slipped 0.2%, and the Nasdaq dropped 1.1%. Amylyx shares had already gained roughly 14.5% in after-hours trading the prior evening.
