Amylyx Pharmaceuticals, Inc. (AMLX) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of $0.24. This compares to earnings of $0.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -291.67%. A quarter ago, it was expected that this company would post earnings of $0.20 per share when it actually produced earnings of $0.07, delivering a surprise of -65%.Over the last four quarters, the company h ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |----------------------------------------------------------------------------------------------------|------------------------------------------| | | | | For the transition peri ...

Exhibit 99.1 Amylyx Pharmaceuticals Reports First Quarter 2024 Financial Results ˗ 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 fall of 2024 ˗ Interim analysis from the ORION study of AMX0035 in progressive supranuclear palsy continues to be expected in mid-2 ...

Amylyx Pharmaceuticals, Inc. (AMLX) announced that it will remove its amyotrophic lateral sclerosis (ALS) drug Relyvrio (sodium phenylbutyrate and taurursodiol, also known as AMX0035) from the U.S. markets and it has already started a process with the FDA on the same.The drug, approved under the brand name Albrioza in Canada, will also be removed from Canadian markets.While the formal decision to remove the drug from these markets has come recently, the company was contemplating the same following the failu ...

CAMBRIDGE, Mass.--(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. 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 Astell ...

Shares of Amylyx Pharmaceuticals (AMLX) nosedived 82.2% on Mar 8 after management announced topline results from the phase III PHOENIX study evaluating Relyvrio (AMX0035) for the treatment of amyotrophic lateral sclerosis (“ALS”). The study did not meet its primary or secondary endpoints.The PHOENIX study failed to achieve statistical significance in the primary endpoint of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score following 48 weeks of treatment with Relyvrio. ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“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 meas ...

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CAMBRIDGE, Mass.--(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 stock option awards to purchase up to 101,400 shares of the Company’s common stock and 67,600 RSUs ...

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q4 2023 Earnings Call Transcript February 22, 2024 8:00 AM ET Company Participants Lindsey Allen - Head, IR & Communications Justin Klee - Co-CEO Jim Frates - CFO Camille Bedrosian - CMO Josh Cohen - Co-CEO Conference Call Participants Charlie Young - Bank of America Neena Bitritto-Garg - Deutsche Bank Canada Corinne Jenkins - Goldman Sachs Michael DiFiore - Evercore ISI Graig Suvannavejh - Mizuho Madhu Yennawar - Leerink Partners Ananda Ghosh - HC Wainwright Opera ...