Amylyx Pharmaceuticals Stock Price, News & Analysis

Amylyx Pharmaceuticals (NASDAQ: AMLX) announced an upcoming investor event at ENDO 2025 on July 13, 2025, focusing on post-bariatric hypoglycemia (PBH) and their drug candidate avexitide. The event will feature presentations of new analyses from Phase 2 PREVENT and Phase 2b clinical trials, including data on hypoglycemic events and pharmacological activity of the 90 mg daily dose.

The company will present two posters at ENDO 2025: one on population pharmacokinetics analysis and another on hypoglycemic event reduction. Notable experts from Stanford University and University of Colorado will join Amylyx's management team. The company's Phase 3 LUCIDITY trial is ongoing, with recruitment completion expected in 2025, data readout in H1 2026, and potential commercial launch in 2027.

Amylyx Pharmaceuticals (NASDAQ: AMLX) has received FDA Fast Track designation for AMX0114, their investigational antisense oligonucleotide (ASO) treatment for ALS. AMX0114 targets calpain-2, a calcium-activated protease linked to axonal degeneration in ALS. The Fast Track status enables more frequent FDA interactions and potential Priority Review. The Phase 1 LUMINA trial, a multinational, randomized, double-blind study, is currently underway with approximately 48 participants receiving intrathecal administration of AMX0114 or placebo. Preclinical studies showed promising results with improved neuronal survival and reduced neurofilament light levels. The company expects early cohort data from the LUMINA trial in 2025.

Amylyx Pharmaceuticals (NASDAQ: AMLX) has announced its participation in three major investor conferences in June 2025:

• Jefferies Global Healthcare Conference: Fireside chat on June 5, 2025, at 1:25 p.m. ET in New York City
• Goldman Sachs 46th Annual Global Healthcare Conference: Fireside chat on June 10, 2025, at 3:20 p.m. ET in Miami, Florida
• Virtual H.C. Wainwright @ Home Fireside Chat Series: Fireside chat on June 26, 2025, at 11:00 a.m. ET

Live webcasts of all presentations will be available on the company's investor relations website for 90 days after the events.

Amylyx Pharmaceuticals (NASDAQ: AMLX) has reported positive 48-week results from its Phase 2 HELIOS clinical trial of AMX0035 in treating Wolfram syndrome. The trial demonstrated sustained improvements or stabilization across multiple disease measures, including pancreatic function, glycemic control, and vision.

Key findings at Week 48 include a mean increase of +34.5 min*ng/mL in C-peptide response, improved glycemic control with HbA1c reduction of -0.40%, and increased time in target glucose range by +9.6%. The treatment was generally well-tolerated, with only mild to moderate adverse events and no serious treatment-related issues. All participants reported stability or improvement in their symptoms according to both patient and clinician assessments.

The company plans to use these results and FDA discussions to design a Phase 3 trial. AMX0035 has received Orphan Drug Designation from both FDA and European Commission for Wolfram syndrome treatment.

Amylyx Pharmaceuticals reported Q1 2025 financial results and pipeline updates. The company is advancing its Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia, with enrollment completion expected in 2025 and topline data in H1 2026. Key financial metrics include cash position of $204.1 million as of March 31, 2025, with runway through 2026, and Q1 net loss of $35.9 million ($0.42/share). R&D expenses decreased to $22.1M from $36.6M YoY, while SG&A expenses dropped to $15.7M from $57.8M. The company recently raised $65.5M through a public offering and began dosing in the Phase 1 LUMINA trial for ALS. Upcoming milestones include Week 48 data from HELIOS trial in Wolfram syndrome and Phase 2b ORION trial results in Q3 2025.

Amylyx Pharmaceuticals (NASDAQ: AMLX) has announced its participation in two major investor conferences in May 2025. The company will conduct a fireside chat at the Bank of America 2025 Health Care Conference on May 13, 2025, at 1:55 p.m. PT in Las Vegas. Additionally, Amylyx will deliver a corporate presentation with Q&A at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, at 5:00 p.m. ET in New York City.

Both presentations will be accessible via live webcast in the Investor section of Amylyx's website under "Events and Presentations" and will remain available for replay for 90 days after the events.

Amylyx Pharmaceuticals (NASDAQ: AMLX) has announced it will release its first quarter 2025 financial results on Thursday, May 8, 2025. The company's senior management will host a conference call and audio webcast at 8:00 a.m. ET to discuss financial results and provide company updates.

Investors can join the call by dialing +1 (800) 836-8184 (U.S. & Canada) or +1 (646) 357-8785 (international). A live audio webcast will be available on the company's investor website and archived for 90 days after the event.

Amylyx Pharmaceuticals has initiated its pivotal Phase 3 LUCIDITY trial for avexitide, dosing its first participant. The trial aims to evaluate this first-in-class GLP-1 receptor antagonist for treating post-bariatric hypoglycemia (PBH).

The study will involve approximately 75 participants across 20 U.S. sites, with completion expected in 2025 and topline data in first half of 2026. The FDA-approved trial will assess avexitide's ability to reduce hypoglycemic events in patients who underwent Roux-en-Y gastric bypass surgery.

Key highlights:

• Avexitide holds FDA Breakthrough Therapy and Orphan Drug Designations
• Previous five clinical trials showed consistent, positive results
• Participants will receive either 90 mg avexitide or placebo daily
• 16-week treatment period followed by 32-week open-label extension
• Company maintains cash runway through end of 2026

Amylyx Pharmaceuticals (NASDAQ: AMLX) has initiated the LUMINA Phase 1 trial for AMX0114, dosing its first participant. This multinational, randomized, double-blind, placebo-controlled study will evaluate AMX0114, an antisense oligonucleotide targeting calpain-2, in people with Amyotrophic Lateral Sclerosis (ALS).

The trial will enroll approximately 48 participants across North America, randomized 3:1 to receive AMX0114 or placebo via intrathecal administration once every four weeks for up to 4 doses. The study aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics, including changes in neurofilament light chain (NfL) levels.

Early cohort data from LUMINA is expected in 2025. Preclinical studies have shown improved neuronal survival and reduced extracellular NfL levels across multiple disease models. The drug targets calpain-2, a calcium-activated protease believed to be a key contributor to axonal degeneration in ALS.