Press Releases

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 4, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the design of its pivotal Phase 3 LUCIDITY clinical trial for avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist, for the treatment of post-bariatric hypoglycemia (PBH).

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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Nov. 27, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that management will participate in the 7th Annual Evercore ISI HealthCONx Conference . The conference is being conducted in-person in Coral Gables, Florida ,...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 7, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the third quarter ended September 30, 2024.

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 4, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its third quarter 2024 financial results on Thursday, November 7, 2024. Amylyx’ senior management team will host a conference call and audio webcast at 8:00 a.m. ET to discuss the financial results and other company updates.

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 17, 2024-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced positive topline data from the Phase 2 open-label HELIOS clinical trial of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in 12 adults living with Wolfram syndrome.

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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Oct. 15, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the Company will host a virtual webcast on October 17, 2024 at 1:30 p.m. ET with management and Fumihiko Urano , MD, PhD, principal investigator of the HELIOS...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 28, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that management will participate in the following upcoming investor conferences, which are being conducted in-person in New York City : Morgan Stanley 22nd...

- Findings from exploratory analysis of the PEGASUS trial provide preliminary evidence that AMX0035 engages multiple pathological pathways related to neurodegeneration, including tau CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 12, 2024-- Amylyx Pharmaceuticals, Inc....

Expanded 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 Company expects to present updated data from its Phase 2 HELIOS trial of...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 5, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its second quarter 2024 financial results on Thursday, August 8, 2024 . Amylyx’ senior management team will host a conference call and audio webcast at 8:00 a.m....

- New designation follows the U.S. Food and Drug Administration (FDA) Orphan Drug Designation for AMX0035 in Wolfram syndrome granted in 2020 - Topline data for all 12 participants from Phase 2 HELIOS trial studying impact of AMX0035 on endocrine, metabolic, and neurodegenerative aspects of Wolfram...

- Avexitide is a novel, first-in-class GLP-1 receptor antagonist with the potential to treat hyperinsulinemic hypoglycemia - FDA Breakthrough Therapy Designation granted for avexitide for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism - Acquisition builds on Amylyx’ endocrine and...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jul. 9, 2024-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that Amylyx’ management team will host a conference call and webcast tomorrow, Wednesday, July 10, 2024 , at 8:00 a.m....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 4, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that management will participate in a fireside chat presentation at the Goldman Sachs 45th Annual Global Healthcare Conference....

Company plans to engage with FDA based on interim data from the Phase 2 HELIOS clinical trial demonstrating improvements in pancreatic function, glycemic control, and vision in participants with Wolfram syndrome treated with AMX0035; topline data from all 12 participants at Week 24 anticipated in...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 8, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Joshua Cohen and Justin Klee , Co-CEOs of Amylyx, and Camille L. Bedrosian , MD, Chief Medical Officer of Amylyx, will participate in the 2024 Bank of...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 2, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its first quarter 2024 financial results on Thursday, May 9, 2024 . Amylyx’ senior management team will host a conference call and audio webcast at 8:00 a.m....

- I nterim analysis, including eight participants assessed at Week 24, demonstrated improvements in pancreatic function and glycemic control, as measured by C-peptide and other markers of glucose metabolism, rather than worsening typically expected with disease progression - All eight participants...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Apr. 8, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the Company will host a virtual webcast with management and Fumihiko Urano , MD, PhD, Principal Investigator of the HELIOS clinical trial and the Samuel E....

- Based on topline results from the Phase 3 PHOENIX trial of AMX0035 in ALS, Amylyx has started a process with the FDA and Health Canada of voluntarily discontinuing the marketing authorizations   for RELYVRIO/ALBRIOZA - RELYVRIO/ALBRIOZA will no longer be available for new patients as of today;...

- Dr. Zeiher brings more than 20 years of drug development experience in areas with serious unmet treatment needs at companies including Astellas Pharma, Pfizer, Eli Lilly and Company, and Merck CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 14, 2024-- Amylyx Pharmaceuticals, Inc....

- PHOENIX Study Did Not Meet Prespecified Primary or Secondary Endpoints - Data From 664-Participant Study Reinforce That AMX0035 is Generally Safe and Well-Tolerated - Within the Next Eight Weeks, Amylyx Will Continue to Engage With Regulatory Authorities and the ALS Community to Share Topline...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 23, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has granted stock options and restricted stock units (“RSUs”) to Linda Arsenault , the Company’s newly appointed Chief Human Resources Officer....

Reported $380.8 million in net product revenue for the full year 2023, including $108.4 million in the fourth quarter Delivered $49.3 million in net income for the full year 2023, including $4.7 million in the fourth quarter, and ended the year with cash, cash equivalents and short-term investments...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 15, 2024-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its fourth quarter and full year 2023 financial results on Thursday, February 22, 2024 . Amylyx’ senior management team will host a conference call and audio...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 15, 2024-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that two abstracts detailing next steps in the development of the Company’s investigational antisense oligonucleotide (ASO), AMX0114, for the potential...

Preliminary results from HELIOS anticipated in the second half of 2024 CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 8, 2024-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced it has completed enrollment of its Phase 2 HELIOS trial of AMX0035 (sodium phenylbutyrate...