<p>Amylyx Pharmaceuticals Inc. announced early safety and tolerability data from its Phase 1 LUMINA trial of AMX0114, an investigational antisense oligonucleotide targeting calpain-2, in people with amyotrophic lateral sclerosis (ALS). The data from the first cohort (n=12) were presented at the 36th International Symposium on ALS/MND held December 5-7, 2025, in San Diego, California. According to the company, AMX0114 was generally well-tolerated, with no treatment-related serious adverse events reported. Based on these findings, enrollment for the second cohort is expected to begin in Canada later this month and in the U.S. in January. Amylyx plans to present biomarker data from the first cohort in the first half of 2026. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amylyx Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251205363745) on December 05, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)</p>

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<p>Amylyx Pharmaceuticals Inc. reported positive early safety data from its Phase 1 LUMINA trial of AMX0114 for ALS. The trial showed AMX0114 was well-tolerated with no serious adverse events in the first cohort. Enrollment for the second cohort will begin soon in Canada and the U.S. Biomarker data from the first cohort will be presented in 2026.</p>

Amylyx Reports Positive Early Safety Data for AMX0114 in ALS Phase 1 LUMINA Trial