Articles from Amylyx Pharmaceuticals, Inc.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the Phase 1 clinical trial of AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for people living with amyotrophic lateral sclerosis (ALS). With the clinical hold lifted, Amylyx is now working to open U.S. sites for screening, enrollment, and dosing.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the pricing of an underwritten public offering of 17,142,857 shares of its common stock at a public offering price of $3.50 per share. All of the shares are being offered by Amylyx. In addition, Amylyx has granted the underwriter a 30-day option to purchase up to an additional 2,571,428 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The gross proceeds to Amylyx from this offering are expected to be approximately $60.0 million, before deducting underwriting discounts and commissions and offering expenses and excluding any exercise of the underwriter’s option to purchase additional shares.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares are being offered by Amylyx. In addition, Amylyx intends to grant the underwriter a 30-day option to purchase additional shares of its common stock in an amount up to 15% of the shares offered in the public offering at the public offering price per share, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the appointment of Dan Monahan as Chief Commercial Officer. Mr. Monahan will also join the Company’s Leadership Team. Mr. Monahan joined Amylyx in January 2024, bringing more than 20 years of commercial leadership experience in the biopharmaceutical industry overseeing sales, marketing, and market access for multiple product lines.

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). LUCIDITY is designed to evaluate the FDA-agreed upon primary outcome of reduction in hypoglycemia events and to have similar inclusion and exclusion criteria to the previous Phase 2 trials of avexitide in PBH. Amylyx expects that the first study participant will be dosed in the first quarter of 2025, followed by expected completion of recruitment in 2025, and anticipates topline data in 2026.

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, and the fireside chat will take place on Wednesday, December 4, 2024, at 11:15 a.m. ET.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the third quarter ended September 30, 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.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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. Wolfram syndrome is a rare, progressive, monogenic disease impacting approximately 3,000 people in the U.S. HELIOS showed improvement in pancreatic function, as measured by C-peptide response after 24 weeks of treatment with AMX0035, the study’s primary efficacy endpoint, in contrast to the expected decrease in pancreatic function with disease progression. Similar overall improvements or stabilization were observed across all secondary endpoints, including hemoglobin A1c (HbA1c), time in target glucose range assessed by continuous glucose monitoring, and visual acuity. Patient- and physician-reported global impressions of change showed disease stability or improvement in all participants, meeting prespecified responder criteria.

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 clinical trial and the Samuel E. Schechter Professor of Medicine in the Division of Endocrinology, Metabolism & Lipid Research at Washington University School of Medicine in St. Louis (WashU Medicine), to discuss topline results from HELIOS, a Phase 2 trial of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) for the investigational treatment of Wolfram syndrome. The live webcast follows the presentation of these data at the International Society for Pediatric and Adolescent Diabetes 50th Annual Congress in Lisbon, Portugal.

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:

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of exploratory analyses on cerebrospinal fluid (CSF) biomarkers from participants with Alzheimer’s disease (AD) from the Phase 2 PEGASUS trial. Data analyses suggest that treatment with AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO]) resulted in consistent changes in AD and neurodegeneration CSF biomarkers in participants with a broad range of disease severity. The results were published in the peer-reviewed medical journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions, a journal of the Alzheimer’s Association.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the second quarter ended June 30, 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. ET to discuss the financial results and other company updates.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced the European Commission (EC), based on a positive opinion issued by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), has granted Orphan Drug Designation for AMX0035, Amylyx’ proprietary, fixed-dose combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO; also known as ursodoxicoltaurine outside of the U.S.) for the treatment of Wolfram syndrome.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced the acquisition of avexitide from Eiger BioPharmaceuticals, Inc. (“Eiger”). Avexitide has been studied for the potential treatment of hyperinsulinemic hypoglycemia to date.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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. ET to discuss the acquisition of avexitide from Eiger BioPharmaceuticals.

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. The conference is being conducted in-person in Miami, Florida, and the fireside chat will take place on Tuesday, June 11, 2024, at 8:00 AM EDT.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the first quarter ended March 31, 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 America Health Care Conference. The conference is being conducted in-person in Las Vegas, Nevada, and the fireside chat will take place on Wednesday, May 15, 2024, at 8:40 a.m. PT/11:40 a.m. ET.

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. ET to discuss the financial results and other company updates.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced interim data from the ongoing Phase 2 HELIOS clinical trial of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults living with Wolfram syndrome, a rare, progressive genetic disease impacting approximately 3,000 people in the U.S. The interim data from eight participants who have completed 24 weeks of treatment demonstrated that AMX0035 had a clinically meaningful effect on key outcomes measuring the progression of diabetes, visual decline, and overall disease burden in adult participants living with Wolfram syndrome.

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 Medicine in St. Louis to discuss interim data from HELIOS, a Phase 2 trial of AMX0035 for the treatment of Wolfram syndrome on April 10, 2024 at 1:30pm ET.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced the Company has started a process with the U.S. Food and Drug Administration (FDA) and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO®/ALBRIOZA™ (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; also known as AMX0035) and remove the product from the market in the U.S. and Canada based on topline results from the Phase 3 PHOENIX trial. 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 stay on treatment can be transitioned to a free drug program.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced the addition of Bernhardt G. Zeiher, MD, FCCP, FACP, to its Board of Directors (“Board”). Dr. Zeiher brings more than 20 years of drug development experience where, in his various roles, he oversaw the approval of 15 new treatments that addressed people’s unmet needs in serious diseases with few to no treatment options. Most recently, he served as Chief Medical Officer (“CMO”) of Astellas Pharma, where he led early- and late-stage drug development, medical and regulatory affairs, pharmacovigilance, and quality assurance.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced topline results from PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; RELYVRIO® in the U.S., ALBRIOZA™ in Canada) in people living with amyotrophic lateral sclerosis (ALS). PHOENIX did not meet its primary endpoint of reaching statistical significance (p=0.667) as measured by change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score at Week 48, nor was there statistical significance seen in secondary endpoints. Amylyx plans to present the data from PHOENIX at an upcoming medical meeting and will publish the results in a medical journal later this year.

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 stock option awards to purchase up to 101,400 shares of the Company’s common stock and 67,600 RSUs under the Amylyx Pharmaceuticals, Inc. 2023 Inducement Plan (“2023 Inducement Plan”). The awards were granted as an inducement material to Ms. Arsenault entering into employment with Amylyx in accordance with Nasdaq Listing Rule 5635(c)(4).

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023.

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.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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 phenylbutyrate [PB] and taurursodiol [TURSO]) in people with ALS will be presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference on March 3-6, 2024 in Orlando, Florida. AMX0035 is marketed by Amylyx as RELYVRIO® and is approved to treat ALS in adults in the U.S. and approved with conditions as ALBRIOZA™ for the treatment of ALS in Canada.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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 neurodegeneration and premature death, which has no known cure. The trial has enrolled 12 adult participants living with WS, and preliminary results are anticipated in the second half of 2024.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced that the first participant has been dosed in ORION, a randomized, double-blind, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO]) for the treatment of progressive supranuclear palsy (PSP). The Phase 3 trial will enroll approximately 600 participants in approximately 100 sites across the United States, Canada, the European Union, the United Kingdom, and Japan, making this the largest PSP clinical trial to date.

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 Psychiatry. During the CENTAUR trial, plasma samples were prospectively collected from trial participants for future biomarker analyses. Post hoc analyses were conducted to look at the impact of AMX0035 on biomarkers shown to correlate with ALS disease progression, including chitinase biomarkers such as YKL-40 (also known as chitinase-3-like protein 1), chitinase 1 (CHIT1), and the systemic inflammatory biomarker C-reactive protein (CRP). The results of these post hoc analyses demonstrated a significant reduction in plasma concentrations of YKL-40 and CRP, but not CHIT1, over 24 weeks, with reductions observed as early as Week 12 in participants from the CENTAUR trial.

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 non-qualified stock option awards to purchase up to 162,500 shares of the Company's common stock and 58,333 RSUs under the Amylyx Pharmaceuticals, Inc. 2023 Inducement Plan (“2023 Inducement Plan”). The awards were granted as an inducement material to Dr. Bedrosian entering into employment with Amylyx in accordance with Nasdaq Listing Rule 5635(c)(4).

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the appointment of Camille L. Bedrosian, MD, as Chief Medical Officer (“CMO”). In this role, Dr. Bedrosian will lead global functions in medical affairs, regulatory, safety and pharmacovigilance, biometrics, clinical development, and clinical operations. Dr. Bedrosian brings nearly 30 years of experience addressing unmet medical needs for people with rare and serious diseases through successful clinical and translational research programs, including as CMO at Ultragenyx Pharmaceutical Inc. (“Ultragenyx”), Alexion Pharmaceuticals, Inc. (“Alexion”), and ARIAD Pharmaceuticals Inc. (“ARIAD”). Amylyx’ current CMO, Patrick Yeramian, MD, MBA, will stay on as an advisor through the end of the year and will then transition into retirement, as announced in December 2022.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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 presented at the 34th International Symposium on ALS/MND. New data using a model for assessing mortality-adjusted progression (MAP) for clinical trials of ALS and encore posters will be presented.

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.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the third quarter ended September 30, 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. ET to discuss the financial results and other company updates.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced an upcoming presentation at Neuro2023 on the design of ORION, a planned global, Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [PB&TURSO]) in progressive supranuclear palsy (PSP). Neuro2023: The PSP and CBD International Research Symposium will take place on October 19-20, 2023, at the Pan Pacific Hotel in London, UK.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its initial negative opinion on the Marketing Authorisation Application (MAA) for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]), under the trade name ALBRIOZA®, for the treatment of amyotrophic lateral sclerosis (ALS) in the European Union (EU). The decision follows the conclusion of the CHMP’s formal re-examination procedure of an initial negative opinion adopted in June 2023.

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 survival of participants in the CENTAUR study versus a historical clinical trial control group. The results of this post hoc analysis, which demonstrated that the median overall survival was 10.4 months longer in the CENTAUR AMX0035 group than in the historical clinical trial control group, are consistent with the data previously presented at the 2023 American Academy of Neurology Annual Meeting.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced the acceptance of several abstracts for presentation at the hybrid 2023 Northeast ALS Consortium (NEALS) Annual Meeting. The data being shared are related to 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. AMX0035 is marketed by Amylyx as RELYVRIO® and is approved to treat ALS in adults in the U.S. and approved with conditions as ALBRIOZA™ for the treatment of ALS in Canada. The in-person component of the NEALS Annual Meeting will take place in Clearwater, Florida October 4-6, 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 following upcoming investor conferences in September, which are being conducted in-person:

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the second quarter ended June 30, 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. 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.

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 Company’s clinical development plans for AMX0035 in PSP on July 26, 2023 at 1:30pm ET.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]), under the trade name ALBRIOZA®, for the treatment of adults with amyotrophic lateral sclerosis (ALS) in the European Union (EU). Today’s update follows the Company’s May 2023 announcement that the CHMP was trending toward a negative opinion.

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 the terms and conditions under which ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) would qualify for reimbursement through federal, provincial, and territorial public drug plans for the treatment of amyotrophic lateral sclerosis (ALS).

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.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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 Use (CHMP) of the European Medicines Agency (EMA). Following an oral explanation held at the May meeting of the CHMP, Amylyx was informed that the CHMP is trending toward a negative opinion on the application for conditional marketing authorisation of AMX0035.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the first quarter ended March 31, 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. 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.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the appointment of Masako Nakamura to General Manager and Head of International Markets - Asia Pacific and Latin America. Ms. Nakamura brings 30 years of commercial, general management, and operational leadership experience in the biopharmaceutical industry with a strong focus on introducing rare disease therapies worldwide across multiple therapeutic areas.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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 phenylbutyrate [PB] and taurursodiol [TURSO]) for the treatment of Wolfram syndrome (WS).

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 22nd 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.

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, effective March 16.

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:

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. 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.

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.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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 (ALS). Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that Joshua Cohen and Justin Klee, Co-CEOs of Amylyx, will participate in the Evercore ISI 5th Annual HealthCONx Conference. The conference is being conducted in a virtual format, and the fireside chat will take place on Tuesday, November 29, 2022 at 3:05 p.m. ET.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the quarter ended September 30, 2022.

Amylyx Pharmaceuticals, Inc. (“Amylyx”) today announced it will report third quarter 2022 financial results on Thursday, November 10, 2022 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.

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 $246.3 million, before deducting underwriting discounts and commissions and estimated offering expenses.

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.

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 stock at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“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, placebo-controlled clinical trial. RELYVRIO can be taken as a monotherapy or with existing approved treatments.

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 Research Institute (NCRI) at Mass General Hospital and is currently sponsored by The ALS Association.

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 treatment of amyotrophic lateral sclerosis (ALS).

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Nasdaq has halted trading of the Company’s common stock.

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 lateral sclerosis (ALS).

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the quarter ended June 30, 2022.

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 to discuss the AMX0035 NDA is scheduled, as published in the Federal Register, for September 7, 2022.

Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) (“Amylyx” or the “Company”) today announced a two-year sponsored research agreement with Sunnybrook Research Institute (SRI) to expedite the identification of novel drug candidates that inhibit Bax and Bak with high potency, specificity and appropriate pharmacokinetic properties for the development as therapeutics for neurodegenerative diseases, specifically in amyotrophic lateral sclerosis (ALS).