Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the launch of a U.S. Expanded Access Program (EAP) for up to 250 adults with post-bariatric hypoglycemia (PBH) to provide treatment access to avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist.

The EAP allows U.S. physicians to request avexitide for adults with PBH following Roux-en-Y gastric bypass (RYGB) surgery who have a serious unmet medical need, are unable to participate in an ongoing clinical trial, have exhausted available management options, and meet all other eligibility criteria. Initial eligible patients include individuals who have completed the pivotal Phase 3 LUCIDITY clinical trial and participants in a prior trial of avexitide in PBH following RYGB surgery.

"Listening to the PBH community is central to our work, and this dialogue directly informed our approach to the U.S. Expanded Access Program for avexitide," said Camille L. Bedrosian, MD, Chief Medical Officer at Amylyx. "The experiences shared by those living with PBH underscore the profound unmet medical need they face every day. This program reflects our commitment to providing a potential option for eligible individuals as we continue to advance avexitide through clinical development."

Avexitide is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) for any indication. Avexitide is being evaluated in the pivotal Phase 3 LUCIDITY clinical trial, a 16-week, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of avexitide in adults with PBH following RYGB surgery. Participants who complete the 16-week double-blind period are eligible to enter a 32-week open-label extension period. The trial has enrolled 78 participants, with topline data readout anticipated in Q3 2026. If approved, commercial launch of avexitide is anticipated in 2027.

Physician Inquiry and Patient Eligibility

Individuals with PBH who are interested in learning more about potential access to avexitide through the EAP should speak with their treating physician or care team to determine whether they may be eligible. Access to avexitide through the EAP is limited, may change over time, and participation is not guaranteed. Additional information about the EAP is available at amylyx.com/global-access-policy.