Amylyx Pharmaceuticals announced that it has finished enrolling all 78 patients in its pivotal Phase 3 LUCIDITY trial of avexitide for post‑bariatric hypoglycemia (PBH). The last participant was randomized and dosed on March 24, 2026, bringing the study to its target enrollment and moving the program from the recruitment phase into data collection.
The completion of enrollment is a critical de‑risking event for Amylyx. With all participants in place, the company can now focus on monitoring outcomes and preparing for the anticipated topline data readout in the third quarter of 2026. A successful data set would support a regulatory submission and could position avexitide as the first‑in‑class GLP‑1 receptor antagonist for a condition that currently has no FDA‑approved therapies.
The post‑bariatric hypoglycemia market is sizable. Estimates range from $341.8 million by 2031 to $752.4 million by 2032, with a 7 million‑patient cohort projected to reach nearly $200 million in 2023 and grow further. Amylyx’s own assessment of a $1 billion‑plus market underscores the potential upside if avexitide gains approval.
Co‑CEOs Joshua Cohen and Justin Klee noted that the enrollment milestone “reduces uncertainty around the trial’s timeline and enhances the likelihood of a timely data presentation.” Chief Medical Officer Camille L. Bedrosian added that the company is “pleased to have completed enrollment” and thanked trial sites and participants for their contributions. Amylyx’s cash runway is projected to extend through 2028, giving the company time to commercialize avexitide and fund future pipeline projects.
Analysts have responded positively to the enrollment completion. Guggenheim raised its price target from $25.00 to $30.00, while HC Wainwright increased its target from $28.00 to $34.00. The upgrades reflect confidence that the milestone de‑risks the development pathway and could accelerate regulatory approval.
In summary, the LUCIDITY trial enrollment completion marks a pivotal step for Amylyx, positioning the company closer to a potential first‑in‑class therapy for PBH, expanding its addressable market, and strengthening its financial outlook for the next several years.
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