Amylyx (AMLX) Climbs to Fresh High as Avexitide Moves Closer to Commercialization

Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) reached a fresh three-year high on Tuesday following impressive phase 3 clinical study results for its post-bariatric hypoglycemia (PBH) treatment candidate, Avexitide. The stock climbed to a record $35.39 intraday, ultimately closing at $35.11, marking a remarkable 63.84 percent increase for the day.

The clinical study revealed Avexitide reduced moderate-to-severe low-blood-sugar episodes by 55 percent in 78 participants, surpassing the placebo. Secondary endpoints demonstrated consistent, highly significant, and clinically meaningful reductions in level 2 and 3 hypoglycemic events. Side effects were mild, primarily including diarrhea and injection site bruising.

Amylyx's Chief Medical Officer, Camille Bedrosian, emphasized the significant milestone, stating the results highlight Avexitide's potential to tackle a critical treatment gap for the PBH community. The company plans to submit a new drug application to the FDA by year-end and present the data at an upcoming medical meeting. The FDA granted Breakthrough Therapy Designation for Avexitide in patients with PBH.

Three investment firms raised their price targets and maintained positive ratings for Amylyx following the results. Notably, hedge funds increased their holdings by 16.45 percent to $567 million after the positive clinical trial outcome. PBH is a chronic metabolic condition affecting approximately 8 percent of people in the US, with no FDA-approved therapies currently available. If approved, Avexitide could build a commercial franchise around an underserved patient population.