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Latest News 2026-08-18T07 : 00 : 00-04 : 00 News : Amylyx Pharmaceuticals Announces Positive Topline Results from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post - Bariatric Hypoglycemia Amylyx Pharmaceuticals Announces Positive Topline Results from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post - Bariatric Hypoglycemia August 18 , 2026 • Share • ( opens new window ) • ( opens new window ) • ( opens new window ) • LUCIDITY met FDA - agreed - upon primary endpoint ; avexitide demonstrated a 55 % reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo ( p = 0.000003 ) • LUCIDITY met all secondary endpoints showing consistent , highly statistically significant , and clinically meaningful reductions in Level 2 by self - monitoring of blood glucose ( SMBG ) , Level 2 by CGM , and Level 3 hypoglycemic events • Avexitide was generally well - tolerated with a favorable safety profile • Amylyx plans to submit an NDA for avexitide with the FDA by year - end ; avexitide has Breakthrough Therapy and Orphan Drug Designations by the FDA Company to host investor conference call today , August 18 , 2026 at 8:00 am ET CAMBRIDGE , Mass .-- ( BUSINESS WIRE ) -- Amylyx Pharmaceuticals , Inc. ( Nasdaq : AMLX ) ( " Amylyx " or the " Company " ) today announced positive topline results from LUCIDITY , a 78 - participant , multicenter , randomized , double - blind , placebo - controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide , an investigational , first - in - class glucagon - like peptide - 1 ( GLP - 1 ) receptor antagonist , in participants with post - bariatric hypoglycemia ( PBH ) following Roux - en - Y gastric bypass ( RYGB ) surgery . LUCIDITY met the FDA - agreed - upon primary endpoint demonstrating a 55 % reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo ( p = 0.000003 ) . In addition , LUCIDITY met all secondary endpoints demonstrating consistent , highly statistically significant , and clinically meaningful reductions in Level 2 hypoglycemic events by self - monitoring of blood glucose ( SMBG ) , Level 2 hypoglycemic events by continuous glucose monitoring ( CGM ) , and Level 3 hypoglycemic events . " PBH is a chronic metabolic condition that causes recurrent and often debilitating hypoglycemia , which has a significant negative impact on patients ' safety and quality of life , " said Marilyn Tan , MD , FACE , Principal Investigator of the LUCIDITY clinical trial and Clinical Professor at the Stanford School of Medicine . " Level 2 and Level 3 hypoglycemic events can be medical emergencies that result in significant cognitive or physical impairment , loss of consciousness , seizures , and the need for assistance from others , underscoring the need for an FDA - approved treatment option . Preventing even one Level 2 or Level 3 event is medically meaningful . I am excited by the LUCIDITY results announced today and the potential to have the first treatment for patients with PBH . " " Today's results are a major milestone that demonstrate avexitide's potential to address a critical treatment gap for the PBH community and represent a meaningful step forward for people living with this condition , " said Camille L. Bedrosian , MD , Chief Medical Officer at Amylyx . " Together with the positive data generated across five previous clinical trials of avexitide in PBH , we believe the LUCIDITY results bring us one step closer to potentially delivering the first approved treatment for people living with PBH . We are moving with urgency to submit an NDA to the FDA by the end of the year . In the meantime , the