Press Releases

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Dec. 4, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of analyses performed on neuroinflammatory biomarkers using plasma samples from participants with amyotrophic lateral sclerosis (ALS) from the...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Nov. 29, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has granted stock options and restricted stock units (“RSUs”) to Camille L. Bedrosian , MD, the Company’s newly appointed Chief Medical Officer....

- Dr. Bedrosian brings to Amylyx nearly 30 years of leadership in clinical research, development, and advancing pipeline programs into commercialized global products including as CMO at Ultragenyx, Alexion, and ARIAD Pharmaceuticals CAMBRIDGE, Mass. --(BUSINESS WIRE)--Nov....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Nov. 27, 2023-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that several abstracts detailing data on AMX0035 (sodium phenylbutyrate and taurursodiol [PB&TURSO]) and the Company’s investigational antisense...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Nov. 21, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Joshua Cohen and Justin Klee , Co-CEOs of Amylyx, will participate in the 6th Annual Evercore ISI HealthCONx Conference ....

Third quarter 2023 product revenue of $102.7 million ; bringing total product revenue to $272.3 million in the first three full quarters of U.S. launch Strong financial position supported by $20.9 million of net income during the third quarter of 2023 and cash, cash equivalents and short-term...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Nov. 2, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its third quarter 2023 financial results on Thursday, November 9, 2023 . Amylyx’ senior management team will host a conference call and audio webcast at 8:00 a.m....

 - ORION is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the safety, efficacy, and tolerability of AMX0035 in adults with PSP - Study anticipates enrolling approximately 600 participants globally, with trial initiation anticipated by the end of 2023 CAMBRIDGE,...

- PHOENIX   Phase 3 trial topline results on track for mid-2024 and will inform regulatory next steps in the EU - Final decision from the European Commission expected by the end of 2023 CAMBRIDGE, Mass. --(BUSINESS WIRE)--Oct. 13, 2023-- Amylyx Pharmaceuticals, Inc....

Results demonstrated a 10.4 month difference in overall survival and a 52% lower risk of death over the duration of the follow-up period CAMBRIDGE, Mass. --(BUSINESS WIRE)--Oct. 10, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of a...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Oct. 5, 2023-- L’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), the national authority for authorizing medicinal products in France , has granted “accès compassionnel” (compassionate access) to AMX0035 (sodium phenylbutyrate and...

Topics include safety data from the AMX0035 U.S. Expanded Access Program, progress on the development of an ALS diagnostic biomarker test, new in vitro data on AMX0114, and more CAMBRIDGE, Mass. --(BUSINESS WIRE)--Oct. 2, 2023-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Sep. 5, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Joshua Cohen and Justin Klee , Co-CEOs of Amylyx, will participate in the following upcoming investor conferences in September, which are being conducted...

Second quarter 2023 product revenue of $98.2 million ; demand and insurance coverage for RELYVRIO ® in U.S. and ALBRIOZA™ in Canada continued to grow Strong financial position supported by $22.1 million of net income during the second quarter of 2023 and cash, cash equivalents and short-term...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 3, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its second quarter 2023 financial results on Thursday, August 10, 2023 , following the close of the U.S. financial markets....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jul. 12, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the Company will host a virtual webcast with Prof. Dr. Günter Höglinger , Director of the Department of Neurology at LMU Hospital ,...

Amylyx will seek re-examination of its Conditional Marketing Authorisation Application CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 23, 2023-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the...

Amylyx will now work with federal, provincial, and territorial drug plans to ensure public coverage is available to eligible Canadians with ALS CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 15, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 6, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Joshua Cohen and Justin Klee , Co-CEOs of Amylyx, will participate in the Goldman Sachs 44th Annual Global Healthcare Conference....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 30, 2023-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced an update on the ongoing review of its Marketing Authorisation Application (MAA) for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as...

˗ First quarter 2023 product revenue of $71.4 million ; commercial launches of RELYVRIO ® in U.S. and ALBRIOZA™ in Canada for the treatment of ALS continue to progress ˗ Regulatory review ongoing in the EU ˗ Expansion of pipeline with first participant dosed in Phase 2 HELIOS study of AMX0035 in...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 5, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its first quarter 2023 financial results on Thursday, May 11, 2023 , following the close of the U.S. financial markets....

Ms. Nakamura brings over 30 years of leadership in commercializing therapies internationally, including most recently as SVP, Head of Asia at Alnylam Pharmaceuticals Joins Amylyx as a key leader with the goal of bringing AMX0035 to as many people who may benefit around the world as possible...

- Recently published preclinical data demonstrate initial proof-of-concept for the therapeutic development of AMX0035 (sodium phenylbutyrate and taurursodiol) in Wolfram syndrome CAMBRIDGE, Mass. --(BUSINESS WIRE)--Apr. 13, 2023-- Amylyx Pharmaceuticals, Inc....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Apr. 11, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Joshua Cohen and Justin Klee , Co-CEOs of Amylyx, will participate in the 22 nd Annual Needham Virtual Healthcare Conference ....

Full year product revenue of $22.2 million ; commercial launches of RELYVRIO ® in U.S. and ALBRIOZA™ in Canada continue to progress Regulatory review ongoing in the EU Karen Firestone , CEO and co-founder of Aureus Asset Management and prior fund manager at Fidelity Investments , appointed to the...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 8, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Joshua Cohen and Justin Klee , Co-CEOs of Amylyx, will participate in the following upcoming investor conferences, which are being conducted in a virtual...

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 7, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its fourth quarter and full year 2022 financial results on Monday, March 13, 2023 , following the close of the U.S. financial markets....

CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 7, 2023-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX), today announced that Joshua Cohen and Justin Klee , Co-CEOs of Amylyx, will participate in the SVB Securities Global Biopharma Conference . The conference is being conducted in a virtual format, and the...

- Topline results expected in 2024 CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 2, 2023-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the completion of enrollment in PHOENIX , a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035...

- Neopharm gains exclusive rights to commercialize AMX0035 in Israel, Gaza, West Bank, and the Palestinian Authority - Agreement marks Amylyx’ first distribution partnership since AMX0035 regulatory approvals and commercial launches in the U.S. and Canada CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx...