Business
Amylyx Pharmaceuticals Reports Second Quarter 2024 Financial Results
Expanded pipeline with avexitide, a Phase 3-ready GLP-1 receptor antagonist with FDA Breakthrough Therapy and Orphan Drug Designations; Phase 3 program
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nExpanded pipeline with avexitide, a Phase 3-ready GLP-1 receptor antagonist with FDA Breakthrough Therapy and Orphan Drug Designations; Phase 3 program initiation in post-bariatric hypoglycemia (PBH) on track for Q1 2025\n\n\n\n\nCompany expects to present updated data from its Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome at ISPAD 2024, including data from all 12 participants at Week 24 and any participant who completed their Week 36 or 48 assessment prior to the data cutoff\n\n\n\n\nMultiple ascending dose clinical trial of AMX0114 in people living with ALS planned to initiate in the second half of 2024\n\n\n\n\nCash, cash equivalents and short-term investments of $309.8 million at June 30, 2024; cash runway expected into 2026\n\n\n\n\nManagement to host conference call and webcast today at 8:00 a.m. Eastern Time\n\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the second quarter ended June 30, 2024.\n\n\n“We recently expanded our late-stage pipeline with our acquisition of avexitide and now have three assets targeting orphan indications. Avexitide is Phase 3-ready with FDA Breakthrough Therapy Designation in post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism, highly statistically significant data from two Phase 2 studies, and an FDA-agreed upon primary outcome for the pivotal study in PBH,” said Joshua Cohen, Co-CEO of Amylyx. “PBH represents a major unmet need with an estimated 160,000 individuals in the U.S. impacted by symptomatic PBH, which can cause brain glucose starvation, known as neuroglycopenia. We are focused on progressing avexitide into Phase 3 development, which is on track to occur in Q1 2025, with topline data anticipated in 2026.”\n\n\n“Our recent restructuring and our focus on efficient and targeted clinical development is expected to help advance all four programs efficiently to potentially bring new treatments to communities with high unmet needs. We continue to make important progress in neurodegenerative diseases and are excited to share updated data from our Wolfram syndrome program in the months ahead,” added Justin Klee, Co-CEO of Amylyx. “We also look forward to initiating a multiple ascending dose clinical trial of AMX0114 in ALS before the end of the year and reporting in...