Business
Amylyx Pharmaceuticals Reports First Quarter 2025 Financial Results
Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA breakthrough therapy designation, underway in
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nPivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA breakthrough therapy designation, underway in post-bariatric hypoglycemia (PBH); completion of recruitment expected in 2025, with topline data anticipated in first half of 2026\n\n\n\n\nData through Week 48 from the ongoing Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome to be presented at the Joint Congress of the European Society for Pediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) taking place from May 10-13\n\n\n\n\nPhase 1 LUMINA trial of AMX0114, an investigational, potent antisense oligonucleotide targeting knockdown of calpain-2, underway in people living with amyotrophic lateral sclerosis (ALS); early cohort data expected in 2025\n\n\n\n\nCash, cash equivalents, and marketable securities of $204.1 million as of March 31, 2025; cash runway expected through the end of 2026\n\n\n\n\nManagement to host conference call and webcast today at 8:00 a.m. Eastern Time\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial and business results for the first quarter ended March 31, 2025.\n\n“During the first quarter, we made continued progress across our pipeline, including strong clinical execution of our pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia. We remain focused on avexitide and continue to expect completion of enrollment in 2025 and topline data in the first half of 2026,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “We also made important progress in dosing the first patient in our Phase 1 LUMINA trial of AMX0114 in ALS, with early cohort data expected later this year. Additionally, we look forward to presenting new, long-term data from the Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome in the coming days, and the topline data from the Phase 2b portion of the Phase 2b/3 ORION trial of AMX0035 are expected in the third quarter. With our momentum so far this year and current anticipated cash runway through the end of 2026, we remain confident in achieving our current goals and look forward to our upcoming milestones.”\n\nFirst Quarter and Recent Updates:\n\n\nAmylyx began dosing in the pivotal Phase 3 LUCIDITY clinical trial of avexitide, a glucagon-like p...