Amylyx Pharmaceuticals, Inc.
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- Amylyx Pharmaceuticals, Inc. Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize novel therapies addressing high unmet needs in neurodegenerative and endocrine diseases. Founded in 2013 and headquartered at 43 Thorndike Street in Cambridge, Massachusetts, the company advances a pipeline of investigational therapies including its lead candidate avexitide, a first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI), both of which carry FDA Breakthrough Therapy and Orphan Drug Designations; AMX0035, an oral fixed-dose combination of sodium phenylbutyrate and taurursodiol targeting endoplasmic reticulum stress and mitochondrial dysfunction for Wolfram syndrome and progressive supranuclear palsy (PSP); and AMX0114, an antisense oligonucleotide inhibiting calpain-2 for amyotrophic lateral sclerosis (ALS), which holds FDA Fast Track Designation. Amylyx operates globally through subsidiaries such as Amylyx Pharmaceuticals Canada Inc. in Calgary, Amylyx Pharmaceuticals Japan K.K., and Amylyx Pharmaceuticals EMEA B.V. in Amsterdam, targeting patient communities in the United States, Canada, Europe and Japan. Recent developments include the July 2024 acquisition of avexitide from Eiger BioPharmaceuticals for $35.1 million plus assumed liabilities and royalties, initiation of the Phase 3 LUCIDITY trial in PBH with first patient dosed in April 2025 and recruitment completion expected in Q1 2026 yielding topline data in Q3 2026, positive Week 48 data from the Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome in May 2025 supporting a planned pivotal Phase 3 start in H2 2026 pending FDA alignment, full enrollment of Phase 1 LUMINA cohort 1 for AMX0114 in ALS in September 2025 with early data presentation at the December 2025 International Symposium on ALS/MND, a December 2024 collaboration with Gubra A/S to develop a novel long-acting GLP-1 receptor antagonist advancing toward a potential development candidate decision soon, and a September 2025 public offering raising approximately $191 million to extend cash runway into 2028 through avexitide's potential 2027 launch if approved.
Company News
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Amylyx Pharmaceuticals to Present Topline Data from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia at ObesityWeek® 2026 Annual Meeting
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Amylyx's Avexitide Phase III Win Sets Up FDA Filing for PBH Treatment
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Amylyx Pharmaceuticals, Inc. (AMLX) Presents at Morgan Stanley 24th Annual Global Healthcare Conference Transcript
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BlackRock Inc. Acquires New Stake in Amylyx Pharmaceuticals, Inc. $AMLX
BlackRock Inc. Acquires New Stake in Amylyx Pharmaceuticals, Inc. $AMLX
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Almitas Capital LLC Buys Shares of 974,881 Amylyx Pharmaceuticals, Inc. $AMLX
Deutsche Bank AG Takes Position in Amylyx Pharmaceuticals, Inc. $AMLX
Why Amylyx Pharmaceuticals Blasted Nearly 79% Higher This Week
Amylyx Pharmaceuticals Announces Pricing of an Upsized $500 Million Underwritten Public Offering of Common Stock
Amylyx Pharmaceuticals Announces Pricing of an Upsized $500 Million Underwritten Public Offering of Common Stock
AMLX Rises as Avexitide Nears 2026-End Filing With Phase III Study Win
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Amylyx Pharmaceuticals Announces $350.0 Million Proposed Public Offering of Common Stock