Shares of Amylyx Pharmaceuticals Inc. (AMLX) rose on Monday after the company announced the timing of its Phase 3 trial results for an experimental treatment for amyotrophic lateral sclerosis (ALS).
The biotech firm said it expects to release top-line data from the late-stage trial in the first quarter of 2025. The announcement followed a 3.2% increase in Amylyx’s stock price during premarket trading, extending gains from the prior session.
Amylyx’s lead candidate, AMX0035, is designed to slow disease progression in ALS patients. The Phase 3 trial, known as PHOENIX, is evaluating the drug’s efficacy and safety in a larger patient population compared to earlier studies. Analysts have noted that positive results could significantly boost the company’s valuation and pave the way for regulatory submissions.
The trial’s outcome has drawn particular attention following the mixed results of Amylyx’s previous Phase 2 study, which showed modest but statistically significant benefits. Investors are closely watching for confirmation of those findings in the larger trial.
Amylyx has not provided additional details on the trial’s design or the specific metrics being measured. The company is scheduled to present further updates during its next earnings call, scheduled for late October.
The stock’s recent movement reflects heightened investor interest in biotech firms developing treatments for neurodegenerative diseases, a sector that has seen increased activity amid growing demand for innovative therapies.
