Amylyx Pharmaceuticals (NASDAQ: AMLX) Announced Monday Evening August 18, 2026 That the Registrational Phase 3 LUCIDITY Clinical Trial of Avexitide (Exendin 9-39, a Peptide GLP-1 Receptor Antagonist Administered as 90 mg Once-Daily Subcutaneous Injection) in Post-Bariatric Hypoglycemia (PBH) Met the FDA-Agreed-Upon Primary Endpoint With a 55% Reduction in the Composite Rate of Level 2 and Level 3 Hypoglycemic Events Versus Placebo (P=0.000003); The Trial Also Met All Secondary Endpoints Including Reductions in Level 2 Events by Self-Monitoring of Blood Glucose (SMBG), Level 2 Events by Continuous Glucose Monitoring (CGM), and Level 3 Hypoglycemic Events; Avexitide Was Generally Well-Tolerated With a Favorable Safety Profile; Amylyx Plans to Submit a New Drug Application (NDA) to the FDA by End of 2026 With Potential Commercial Launch in 2027 if Approved; If Approved, Avexitide Would Be the First FDA-Approved Therapy for Post-Bariatric Hypoglycemia and the First Phase 3 Success for a GLP-1 Receptor Antagonist Mechanism
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced Monday evening August 18, 2026 that the registrational Phase 3 LUCIDITY clinical trial of avexitide in post-bariatric hypoglycemia (PBH) met the FDA-agreed-upon primary endpoint with a 55% reduction in the composite rate of Level 2 (blood glucose < 54 mg/dL) and Level 3 (severe cognitive impairment requiring external assistance) hypoglycemic events versus placebo (p=0.000003). The trial enrolled 78 participants with PBH following Roux-en-Y gastric bypass surgery, randomized 3:2 to avexitide 90 mg once-daily subcutaneous injection or placebo for 16 weeks across 21 US sites. All secondary endpoints were met: consistent, highly statistically significant, and clinically substantial reductions in Level 2 events by self-monitoring of blood glucose (SMBG), Level 2 events by continuous glucose monitoring (CGM), and Level 3 hypoglycemic events. Avexitide was generally well-tolerated with a favorable safety profile. Mechanism: avexitide is exendin (9-39), a 30-amino-acid peptide that binds the GLP-1 receptor without activating it, blocking excessive endogenous GLP-1 signaling that drives postprandial hypoglycemia in the reconfigured gastrointestinal anatomy after Roux-en-Y gastric bypass. Amylyx plans to submit a New Drug Application (NDA) to the FDA by end of 2026 with potential commercial launch in 2027 if approved. If approved, avexitide would be the first FDA-approved therapy for post-bariatric hypoglycemia (which has no currently approved drug therapy) and the first Phase 3 success for a GLP-1 receptor antagonist mechanism (the mechanistic opposite of the semaglutide/tirzepatide agonist class).