Amylyx Pharmaceuticals, Inc. - Common Stock (AMLX)

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.

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WHY: NEW YORK, NY - (NewMediaWire) - April 08, 2024 - Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Amylyx Pharmaceuticals, Inc. (NASDAQAMLX) between November 11, 2022 and November 8, 2023, both dates inclusive (the “Class Period”), of the important April 9, 2024 lead plaintiff deadline.

The Law Offices of Frank R. Cruz reminds investors of the upcoming April 9, 2024 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who acquired Amylyx Pharmaceuticals, Inc. (“Amylyx” or the “Company”) (NASDAQAMLX) securities between November 11, 2022 and November 8, 2023, inclusive (the “Class Period”).