Amylyx completes LUCIDITY dosing period, sets late-August/early-September readout

Amylyx Pharmaceuticals reported on August 6, 2026 that the last participant has recently completed the final study visit in the 16-week double-blind period of the pivotal Phase 3 LUCIDITY clinical trial of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has received U.S. FDA Breakthrough Therapy Designation in post-bariatric hypoglycemia (PBH)¹. LUCIDITY enrolled 78 participants and is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of avexitide in adults with PBH following Roux-en-Y gastric bypass surgery¹. The company said topline data readout for the trial is on track and anticipated in late August or early September 2026, evaluating the FDA-agreed-upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16¹. If approved, commercial launch of avexitide is anticipated in 2027¹.

In other pipeline updates, Amylyx announced the initiation of a U.S. Expanded Access Program for the use of avexitide to treat adults with PBH following RYGB surgery in May 2026¹. Amylyx entered into a second research collaboration with Gubra A/S in July 2026 to identify potential development candidates for a rare endocrine disease of high unmet need¹. For its ALS program, AMX0114 showed no drug-related serious adverse events and no serious neurological AEs in Cohort 1, the lowest of four planned dose levels; Cohorts 1 (12.5 mg) and 2 (25 mg) are fully enrolled, and Cohort 3 (50 mg) is currently enrolling¹. The company also said IND-enabling studies for AMX0318, a novel GLP-1 receptor antagonist for long-acting administration to treat PBH and other rare diseases, are underway with an IND filing targeted for 2027¹.

On finances, cash, cash equivalents, and short-term investments were $250.8 million at June 30, 2026, compared to $279.8 million at March 31, 2026, and Amylyx expects a cash runway into 2028¹.