Interim 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 met prespecified responder criteria demonstrating either improvement or stabilization of disease according to both the Patient... Read More

CAMBRIDGE, Mass. / Apr 08, 2024 / Business Wire / 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. Schechter Professor of Medicine in the Division of Endocrinology, Metabolism & Lipid Research at Washington University School of... Read More

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; Patients currently on therapy in the U.S. and Canada who, in consultation with their physician, wish to continue can be transitioned to a... Read More

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. / Mar 14, 2024 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the addition of Bernhardt G. Zeiher, MD, FCCP, FACP, to its Board of Directors (“Board”). Dr.... Read More

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 Data; Amylyx Will Share Plans for RELYVRIO/ALBRIOZA in ALS Which May Include Voluntarily Withdrawing RELYVRIO/ALBRIOZA From the Market At... Read More

CAMBRIDGE, Mass. / Feb 23, 2024 / Business Wire / 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. The Compensation Committee of Amylyx’ Board of Directors approved the grant, effective February 20, 2024, to Ms. Arsenault of non-qualified... Read More

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 of $371.4 million Management to host conference call and webcast today at 8:00 a.m. Eastern Time CAMBRIDGE, Mass. / Feb 22, 2024... Read More

CAMBRIDGE, Mass. / Feb 15, 2024 / Business Wire / 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 webcast at 8:00 a.m. ET to discuss the financial results and other company updates. To access the conference call, please dial +1 (800)... Read More

CAMBRIDGE, Mass. / Feb 15, 2024 / Business Wire / 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 treatment of amyotrophic lateral sclerosis (ALS) and findings from a pharmacokinetic and pharmacodynamic study of AMX0035 (sodium... Read More

Preliminary results from HELIOS anticipated in the second half of 2024 CAMBRIDGE, Mass. / Feb 08, 2024 / Business Wire / 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 [PB] and taurursodiol [TURSO]) for the treatment of Wolfram syndrome (WS), a rare genetic disease that typically results in... Read More

Largest ever PSP clinical trial will evaluate the efficacy and safety of AMX0035 in adults with PSP compared to placebo Trial to enroll approximately 600 participants across the U.S., Canada, Europe, and Japan CAMBRIDGE, Mass. / Dec 22, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the first participant has been dosed in ORION, a randomized, double-blind,... Read More

CAMBRIDGE, Mass. / Dec 04, 2023 / Business Wire / 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 Phase 2 CENTAUR trial. These findings were published in the peer-reviewed medical journal, Journal of Neurology, Neurosurgery and... Read More

CAMBRIDGE, Mass. / Nov 29, 2023 / Business Wire / 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. The Compensation Committee of Amylyx’ Board of Directors approved the grant, effective November 27, 2023, to Dr. Bedrosian of... Read More

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. / Nov 28, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the appointment of Camille L. Bedrosian, MD, as Chief... Read More

CAMBRIDGE, Mass. / Nov 27, 2023 / Business Wire / 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 oligonucleotide, AMX0114, for the potential treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases will be... Read More

CAMBRIDGE, Mass. / Nov 21, 2023 / Business Wire / 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. The conference is being conducted in-person in Miami, Florida and the fireside chat will take place on Tuesday, November 28, 2023, at 2:10pm ET. A live webcast of... Read More

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 investments of $355.0 million at September 30, 2023 Management to host a conference call and webcast today at 8:00 a.m. Eastern Time... Read More

CAMBRIDGE, Mass. / Nov 02, 2023 / Business Wire / 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. ET to discuss the financial results and other company updates. To access the conference call, please dial (833) 816-1395 (U.S.) or... Read More

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, Mass. / Oct 19, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced an... Read More

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. / Oct 13, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)... Read More

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. / Oct 10, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of a post hoc analysis in the peer-reviewed medical journal, Annals of Clinical and Translational Neurology comparing the long term... Read More

CAMBRIDGE, Mass. / Oct 05, 2023 / Business Wire / 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 ursodoxicoltaurine [also known as taurursodiol]) for eligible people living with amyotrophic lateral sclerosis (ALS) following a... Read More

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. / Oct 02, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the acceptance of several abstracts for presentation at the hybrid 2023 Northeast ALS Consortium (NEALS) Annual... Read More

CAMBRIDGE, Mass. / Sep 05, 2023 / Business Wire / 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 in-person: H.C. Wainwright 25th Annual Global Investment Conference: Presentation followed by Q&A on Monday, September 11, 2023, at... Read More

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 investments of $357.3 million at June 30, 2023 Management to host conference call and webcast today at 4:30 p.m. Eastern Time CAMBRIDGE,... Read More

CAMBRIDGE, Mass. / Aug 03, 2023 / Business Wire / 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. Amylyx’ senior management team will host a conference call and audio webcast at 4:30 p.m. ET to discuss the financial results and other company updates. To access the... Read More

CAMBRIDGE, Mass. / Jul 12, 2023 / Business Wire / 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, Ludwig-Maximilians-University (LMU) Munich, Germany, to discuss the treatment landscape for people living with progressive supranuclear palsy (PSP) and the... Read More

Amylyx will seek re-examination of its Conditional Marketing Authorisation Application CAMBRIDGE, Mass. / Jun 23, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the application for conditional marketing authorisation of AMX0035... Read More

Amylyx will now work with federal, provincial, and territorial drug plans to ensure public coverage is available to eligible Canadians with ALS CAMBRIDGE, Mass. / Jun 15, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has completed the negotiation process and entered into a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) for... Read More

CAMBRIDGE, Mass. / Jun 06, 2023 / Business Wire / 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. The conference is being conducted in person in Dana Point, CA, and the fireside chat will take place on Tuesday, June 13, 2023, at 4:40pm PT/7:40pm ET. A... Read More

CAMBRIDGE, Mass. / May 30, 2023 / Business Wire / 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 taurursodiol]) for the treatment of adults with amyotrophic lateral sclerosis (ALS) by the Committee for Medicinal Products for Human... Read More

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 Wolfram syndrome and planned initiation of a pivotal Phase 3 study in progressive supranuclear palsy anticipated this year Management to... Read More

CAMBRIDGE, Mass. / May 05, 2023 / Business Wire / 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. Amylyx’ senior management team will host a conference call and audio webcast at 4:30 p.m. ET to discuss the financial results and other company updates. To access the... Read More

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 CAMBRIDGE, Mass. / Apr 20, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. ( Nasdaq: AMLX) (“Amylyx” or the “Company”) today... Read More

Recently published preclinical data demonstrate initial proof-of-concept for the therapeutic development of AMX0035 (sodium phenylbutyrate and taurursodiol) in Wolfram syndrome CAMBRIDGE, Mass. / Apr 13, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the first participant has been dosed in the HELIOS study, a Phase 2 clinical trial of AMX0035 (sodium... Read More

CAMBRIDGE, Mass. / Apr 11, 2023 / Business Wire / 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. The conference is being conducted in a virtual format, and the presentation will take place on Tuesday, April 18, 2023, at 12:45pm ET. A live webcast of the... Read More

CAMBRIDGE, Mass. / Mar 13, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2022. The Company also announced the appointment of Karen Firestone, Chairman, CEO, and co-founder of Aureus Asset Management and prior fund manager at Fidelity Investments, to the Company’s Board of Directors,... Read More

CAMBRIDGE, Mass. / Mar 08, 2023 / Business Wire / 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 format: Oppenheimer 33rd Annual Healthcare Conference: Fireside chat on Tuesday, March 14, 2023, at 8:40am ET Stifel 2023 CNS Days:... Read More

CAMBRIDGE, Mass. / Feb 07, 2023 / Business Wire / 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 fireside chat will take place on Tuesday, February 14, 2023, at 10:00am ET. A live webcast of the presentation can be accessed under... Read More

Topline results expected in 2024 CAMBRIDGE, Mass. / Feb 02, 2023 / Business Wire / - 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 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) in people living with amyotrophic lateral sclerosis... Read More

Amylyx Pharmaceuticals, Inc. (“Amylyx”) today announced the closing of its previously announced upsized underwritten public offering of 7,697,812 shares of its common stock at a public offering price of $32.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to an additional 1,004,062 shares of common stock in the offering. The gross proceeds to Amylyx from the offering were... Read More

Amylyx Pharmaceuticals, Inc. (“Amylyx”) today announced the pricing of an upsized underwritten public offering of 6,693,750 shares of its common stock at a public offering price of $32.00 per share. All of the shares of common stock are being offered by Amylyx. Amylyx has granted the underwriters a 30-day option to purchase up to an additional 1,004,062 shares of common stock at the public offering price, less underwriting... Read More

Amylyx Pharmaceuticals, Inc. (“Amylyx”) today announced the launch of an underwritten public offering of 6,000,000 shares of common stock pursuant to a registration statement on Form S-1 filed with the U.S. Securities and Exchange Commission (“SEC”). All of the shares of common stock are being offered by Amylyx. Amylyx expects to grant the underwriters a 30-day option to purchase up to an additional 900,000 shares of common... Read More

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved RELYVRIO™ (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS). RELYVRIO (previously known as AMX0035 in the U.S.) significantly slowed the loss of physical function in people living with ALS in a randomized,... Read More

Amylyx Pharmaceuticals, Inc. today announced that the donated clinical data from the placebo arm of the CENTAUR clinical trial that evaluated the safety, efficacy, and survival benefits of AMX0035 in adult participants with amyotrophic lateral sclerosis (ALS) are now available in the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. The PRO-ACT project is led by Alex Sherman at the Neurological Clinical... Read More

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) announced today that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) voted (7 yes votes and 2 no votes) that the available evidence of effectiveness is sufficient to support approval of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the... Read More

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Nasdaq has halted trading of the Company’s common stock. The second meeting of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) is occurring today to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as... Read More

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic... Read More

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the quarter ended June 30, 2022. “The second quarter of 2022 has been another exciting time for Amylyx, marked by our first regulatory approval. ALBRIOZA™ is now commercially available in Canada, signifying an important milestone on our path to helping people living with ALS,” said Justin Klee, Co-CEO of Amylyx. Josh... Read More

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). The second virtual meeting of the PCNSDAC... Read More