Amylyx Pharmaceuticals, Inc.

Aug 20, 2026

Amylyx Pharmaceuticals Announces Pricing of an Upsized $500 Million Underwritten Public Offering of Common Stock

Amylyx Pharmaceuticals has successfully priced an upsized public offering of 14,090,000 shares at $35.50 each, raising $500 million. The company has also provided underwriters with a 30-day option to purchase an additional 2,113,500 shares. This move reflects strong market interest and aims to support the company's growth initiatives.

Aug 18, 2026

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Amylyx Pharmaceuticals Announces $350.0 Million Proposed Public Offering of Common Stock

Amylyx Pharmaceuticals has announced a public offering of $350 million in common stock. The company also plans to give underwriters a 30-day option to buy an additional $52.5 million in shares. This move aims to enhance its financial resources for future initiatives.

Aug 18, 2026

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Amylyx Pharmaceuticals Announces Positive Topline Results from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia

Amylyx Pharmaceuticals announced positive topline results from its Phase 3 LUCIDITY trial, which evaluated avexitide for treating post-bariatric hypoglycemia. The study included 78 participants and was designed as a multicenter, randomized, double-blind, placebo-controlled trial. These results suggest that avexitide may be an effective treatment option for patients experiencing hypoglycemia after Roux-en-Y gastric bypass.

Aug 17, 2026

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Amylyx Pharmaceuticals to Announce Topline Results from its Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia on August 18, 2026

Amylyx Pharmaceuticals is set to announce topline results from its Phase 3 LUCIDITY Clinical Trial of Avexitide, targeting Post-Bariatric Hypoglycemia, on August 18, 2026. The announcement will be followed by a conference call hosted by the senior management team. This trial represents a crucial step in the company's clinical development efforts.

Amylyx Pharmaceuticals Reports Second Quarter 2026 Financial Results

Amylyx Pharmaceuticals has reported its financial results for the second quarter of 2026. The announcement was made from their headquarters in Cambridge, Massachusetts. Details regarding revenue, expenses, and other financial metrics were not provided in the brief report.

Aug 3, 2026

Amylyx Pharmaceuticals to Report Second Quarter 2026 Financial Results on August 6, 2026

Amylyx Pharmaceuticals has announced that it will report its financial results for the second quarter of 2026 on August 6, 2026. This announcement is part of their regular financial reporting schedule. The company is based in Cambridge, Massachusetts, and is focused on developing therapies for neurological diseases.

Jun 23, 2026

Amylyx Pharmaceuticals to Present Data from First-in-Human, Dose-Ranging Phase 1 LUMINA Trial of AMX0114 in ALS at ENCALS 2026

Amylyx Pharmaceuticals is set to present data from the first-in-human, dose-ranging Phase 1 LUMINA trial of AMX0114 in ALS at the upcoming ENCALS 2026 conference. This trial aims to evaluate the safety and efficacy of AMX0114 for patients with Amyotrophic Lateral Sclerosis (ALS). The presentation will provide insights into the trial's findings and implications for future research.

Jun 8, 2026

Amylyx Pharmaceuticals Announces Poster Presentations at ENDO 2026

Amylyx Pharmaceuticals announced two poster presentations at ENDO 2026, focusing on post-bariatric hypoglycemia (PBH) and the LUCIDITY trial of avexitide. The first presentation discusses the burden of PBH on healthcare, while the second outlines participant-centric trial design for avexitide, a GLP-1 receptor antagonist. Avexitide has received Breakthrough Therapy Designation from the FDA.

Amylyx Pharmaceuticals Reports First Quarter 2026 Financial Results • Topline data readout from Phase 3 LUCIDITY clinical trial of avexitide in post-bariatric hypoglycemia on track; anticipated in Q3 2026 •

Amylyx Pharmaceuticals reported its financial results for Q1 2026, highlighting that cash resources should support operations through potential avexitide commercialization and into 2028. The company has completed enrollment in its Phase 3 LUCIDITY trial for avexitide, with topline data expected in Q3 2026. The treatment, aimed at post-bariatric hypoglycemia, has received FDA Breakthrough Therapy Designation, indicating regulatory support. However, the company experienced an increase in both net loss and R&D expenses during the quarter.

May 5, 2026

Amylyx Pharmaceuticals Announces U.S. Expanded Access Program for Adults with Post-Bariatric Hypoglycemia

Amylyx Pharmaceuticals has announced the initiation of a U.S. Expanded Access Program for adults suffering from post-bariatric hypoglycemia. This program aims to provide access to their treatment for patients who may not qualify for clinical trials. The announcement highlights the company's commitment to addressing this condition.

Mar 24, 2026

MARCH 2026 We have an audacious mission to develop novel therapies for diseases with high unmet needs, with a focus on serious and fatal endocrine conditions and neurodegenerative diseases. Maggie, a mom and advocate liv

Amylyx Pharmaceuticals is advancing its novel therapies targeting diseases with high unmet needs, particularly focusing on post-bariatric hypoglycemia and neurodegenerative conditions. Upcoming clinical trials, including the Phase 3 LUCIDITY trial for avexitide, are expected to provide significant data by Q3 2026. The company is collaborating with various experts to ensure efficient development and regulatory strategies. While there is enthusiasm for their pipeline, there are inherent uncertainties and financial risks involved in the clinical processes and overall operational sustainability.

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results

Amylyx Pharmaceuticals reported its financial results for Q4 and full year 2025, highlighting progress in its avexitide program for post-bariatric hypoglycemia (PBH). The company has completed recruitment for its Phase 3 LUCIDITY trial and anticipates topline data in Q3 2026. Additionally, early data from the Phase 1 LUMINA trial of AMX0114 for ALS showed promising safety results. Despite a net loss of $144.7 million for the year, Amylyx maintains a strong cash position extending into 2028.

Feb 26, 2026

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Amylyx Pharmaceuticals to Participate in Upcoming March 2026 Investor Conferences

Amylyx Pharmaceuticals has announced its participation in upcoming investor conferences in March 2026. The company will provide live webcasts of the presentations, which will be available for replay for 90 days. Amylyx is dedicated to developing therapies for diseases with significant unmet needs, showcasing its commitment to innovation and community service.

Feb 24, 2026

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Amylyx Pharmaceuticals to Report Fourth Quarter and Full Year 2025 Financial Results on March 3, 2026

Amylyx Pharmaceuticals will announce its fourth quarter and full year 2025 financial results on March 3, 2026. The company's senior management will host a conference call at 8:00 a.m. ET to discuss these results and provide additional updates. Interested parties can access the call via phone or through a live audio webcast.

Feb 4, 2026

2021 Sparked a Banner Year for Biotech IPOs. Where Are They Now?

The article discusses the surge in biotech IPOs during 2021, driven by pandemic-related investments, and the subsequent challenges faced by many of these companies. While some have thrived, others have struggled or gone bankrupt, revealing a gap between financial momentum and biological maturity. The current market is described as a recalibration, with later-stage companies now better positioned for public offerings.

Jan 8, 2026

JANUARY 2026 We have an audacious mission to develop novel therapies for diseases with high unmet needs, with a focus on serious and fatal neurodegenerative diseases and endocrine conditions. Maggie, a mom and advocate l

Amylyx is intensifying its mission to develop innovative therapies targeting severe neurodegenerative diseases and endocrine conditions, notably focusing on post-bariatric hypoglycemia (PBH). Key clinical trials are underway, including the Phase 3 LUCIDITY trial for avexitide, with initial data expected in Q3 2026. The company is also pursuing new treatments for conditions such as Wolfram syndrome and ALS. However, these forward-looking initiatives face inherent risks linked to regulatory approvals and the outcomes of clinical studies.

Dec 8, 2025

Amylyx Pharmaceuticals Announces New Safety and Tolerability Cohort 1 Data of AMX0114 in ALS from First-in-Human LUMINA Trial

Amylyx Pharmaceuticals has announced positive early safety and tolerability data for AMX0114 from the Phase 1 LUMINA trial, presented at the 36th International Symposium on ALS/MND. The drug was well-tolerated among the first cohort of participants, with no serious adverse events reported. Enrollment for the second cohort is expected to start soon, indicating progress in addressing ALS.

Amylyx Pharmaceuticals Reports Third Quarter 2025 Financial Results • Completion of recruitment for pivotal Phase 3 LUCIDITY trial of avexitide expected in Q1 2026, with topline data anticipated in Q3 2026 &#x2022

Amylyx Pharmaceuticals has announced its financial results for Q3 2025 and updates on its key clinical trials. The company expects to complete recruitment for the pivotal Phase 3 LUCIDITY trial of avexitide by Q1 2026, with topline data anticipated by Q3 2026. Amylyx reported a net loss of $34.4 million for the quarter but has secured a cash runway expected to extend into 2028, facilitating further development of its investigational therapies. Additionally, encouraging early data from other ongoing trials were highlighted, including the Phase 1 LUMINA trial for AMX0114 in ALS and AMX0035 in Wolfram syndrome.

Aug 7, 2025

Amylyx Pharmaceuticals Reports Second Quarter 2025 Financial Results • Completion of recruitment for pivotal Phase 3 LUCIDITY trial of avexitide in PBH expected in 2025, with topline data anticipated in first half

Amylyx Pharmaceuticals reported its second quarter 2025 financial results, revealing a net loss of $41.4 million. The company is on track to complete recruitment for its pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia (PBH) by 2025, with topline data expected in the first half of 2026. Additionally, Amylyx highlighted the recent FDA Fast Track designation for its ALS treatment AMX0114, and the promising long-term outcomes from related clinical trials. The company's cash position remains strong with $180.8 million available through the end of 2026.

Amylyx Pharmaceuticals Reports First Quarter 2025 Financial Results • Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA breakthrough therapy designation, un

Amylyx Pharmaceuticals announced its financial results for Q1 2025, showcasing progress in clinical trials, particularly with avexitide for post-bariatric hypoglycemia. The pivotal Phase 3 LUCIDITY trial is currently underway, with completion of enrollment expected in 2025. Additionally, significant data from the Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome is set to be presented shortly. Despite a net loss of $35.9 million this quarter, the company's financial stability is bolstered by a cash position that supports operations through 2026.

Mar 4, 2025

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results • Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist, in post-bariatric hypoglycemi

Amylyx Pharmaceuticals has reported its financial results for Q4 and the full year 2024, detailing the progress of its clinical trials and financial strategies. The company has initiated a pivotal Phase 3 trial for avexitide aimed at treating post-bariatric hypoglycemia, with topline data expected by mid-2026. Additionally, Amylyx completed a $65.5 million public offering, extending its cash runway to the end of 2026. However, the company faced a substantial net loss during 2024, impacting its financial position despite the successful financing efforts.

Amylyx Pharmaceuticals Reports Third Quarter 2024 Financial Results • On track to initiate a Phase 3 program for Company's lead asset avexitide, a GLP-1 receptor antagonist with FDA Breakthrough Therapy and Orphan

Amylyx Pharmaceuticals announced its third quarter financial results, highlighting the planned initiation of a Phase 3 program for avexitide in post-bariatric hypoglycemia in early 2025. The company reported positive results from the Phase 2 HELIOS clinical trial of AMX0035, showing significant improvements in Wolfram syndrome patients. Despite a low net product revenue of $0.4 million, Amylyx maintains a robust cash position expected to carry through to 2026, bolstering its capacity to advance its clinical pipeline. Upcoming milestones include further data from ongoing trials and the launch of a new ALS study in Canada.

Aug 8, 2024

Amylyx Pharmaceuticals Reports Second Quarter 2024 Financial Results • Expanded pipeline with avexitide, a Phase 3-ready GLP-1 receptor antagonist with FDA Breakthrough Therapy and Orphan Drug Designations; Phase

Amylyx Pharmaceuticals reported its financial results for Q2 2024, highlighting the expansion of its pipeline with avexitide, a Phase 3-ready GLP-1 receptor antagonist. The company plans to initiate a Phase 3 trial for avexitide targeting post-bariatric hypoglycemia in Q1 2025, with an expected data readout in 2026. Despite a reported net product revenue decline to $(1.0) million, the company maintains a strong cash position of $309.8 million, which is anticipated to support its operations into 2026. Additionally, Amylyx plans to present data from its Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome at the ISPAD Conference in October 2024.

May 9, 2024

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,

Amylyx Pharmaceuticals reported its first quarter 2024 financial results, highlighting positive interim data from the Phase 2 HELIOS clinical trial for AMX0035, which showed improvements for patients with Wolfram syndrome. The company plans to engage with the FDA based on this data. However, it also announced the voluntary discontinuation of its product RELYVRIO/ALBRIOZA after negative Phase 3 trial results, affecting their financials with significant write-downs. Looking ahead, Amylyx intends to initiate a clinical trial for another treatment, AMX0114, for ALS later in 2024.

Apr 4, 2024

Amylyx Pharmaceuticals Announces Formal Intention to Remove RELYVRIO /ALBRIOZA from the Market; Provides Updates on Access to Therapy, Pipeline, Corporate Restructuring, and Strategy - Based on topline results from the P

Amylyx Pharmaceuticals has announced its intention to voluntarily discontinue the marketing authorizations for its drug RELYVRIO/ALBRIOZA following topline results from the Phase 3 PHOENIX trial for ALS. This decision, effective immediately, will prevent new patients from starting the therapy while providing an option for current patients to transition to a free drug program. The company is also restructuring by reducing its workforce by 70% to focus resources on other key development programs, specifically AMX0035 and AMX0114. Despite these difficulties, Amylyx plans to continue advancing its pipeline in neurodegenerative diseases and will present interim data from other studies in the coming months.

Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS - PHOENIX Study Did Not Meet Prespecified Primary or Secondary Endpoints - Data From 664-Participant Study Reinforce Th

Amylyx Pharmaceuticals disclosed that its global Phase 3 PHOENIX trial for AMX0035 in ALS failed to meet its primary and secondary endpoints, raising disappointing concerns regarding the drug's efficacy. Despite the negative trial results, the company reported that AMX0035 remains generally safe for its users. Consequently, Amylyx plans to engage with regulatory authorities and the ALS community on next steps, which may involve pausing promotion of the drug while maintaining its availability for ALS patients. Future studies of AMX0035 for other indications like Wolfram syndrome and PSP will also proceed as planned.

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results • Reported $380.8 million in net product revenue for the full year 2023, including $108.4 million in the fourth quarter • D

Amylyx Pharmaceuticals has reported strong financial results for the fourth quarter and full year 2023, demonstrating significant revenue growth with $380.8 million in total net product revenue. The company highlighted the success of RELYVRIO, its innovative ALS treatment, which has been shown to slow disease progression. They also reiterated their commitment to advancing their pipeline, particularly with upcoming data from Phase 3 and Phase 2 trials. Despite the positive revenue trajectory, Amylyx faces rising operational costs associated with increased R&D and administrative expenses.

Amylyx Pharmaceuticals Reports Third Quarter 2023 Financial Results ˗ 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.

Amylyx Pharmaceuticals reported strong financial results for the third quarter of 2023, with product revenue reaching $102.7 million and a total of $272.3 million since the U.S. launch. The company is encouraged by the adoption of its ALS treatment, RELYVRIO, and anticipates topline data from its Phase 3 PHOENIX trial in Q2 2024. However, it faces challenges such as a negative opinion from the CHMP regarding AMX0035's marketing approval in the EU. The overall financial health remains strong with a net income of $20.9 million reported for the quarter.

Aug 10, 2023

Amylyx Pharmaceuticals Reports Second Quarter 2023 Financial Results ˗ Second quarter 2023 product revenue of $98.2 million; demand and insurance coverage for RELYVRIO in U.S. and ALBRIOZA in Canada continued to gr

Amylyx Pharmaceuticals announced its financial results for the second quarter of 2023, reporting product revenue of $98.2 million and a net income of $22.1 million. The company highlighted steady progress in the commercial launches of its therapies RELYVRIO and ALBRIOZA, alongside expanding public reimbursement in Canada. Additionally, Amylyx plans to initiate a pivotal Phase 3 trial of AMX0035 for progressive supranuclear palsy. However, the company is also faced with a negative initial opinion from the European Medicines Agency regarding AMX0035, which is undergoing re-examination.

Jul 26, 2023

Progressive Supranuclear Palsy (PSP) Investor and Analyst Conference Call

During the conference call held on July 26, 2023, Amylyx presented updates on AMX0035, a potential treatment for Progressive Supranuclear Palsy (PSP). The Phase 3 ORION clinical trial aims to assess AMX0035's efficacy, which has shown promise in preclinical studies. Experts emphasized the interconnected nature of neurodegenerative diseases and the need for multi-pathway therapies like AMX0035. However, the company acknowledged the risks and uncertainties associated with the ongoing development.

Amylyx Pharmaceuticals Receives CHMP Negative Opinion on its Conditional Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union Amylyx will seek re-examination of its Conditional M

Amylyx Pharmaceuticals has received a negative opinion from the CHMP regarding its application for conditional marketing authorization of AMX0035 for ALS treatment in the EU. Despite this setback, the company plans to request a formal re-examination of the application, highlighting confidence in their trial data. The CENTAUR trial met its primary endpoints, showing both functional benefits and improved survival rates. The company is also progressing with a Phase 3 study, with topline results expected in mid-2024.

May 11, 2023

Amylyx Pharmaceuticals Reports First Quarter 2023 Financial Results ˗ 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 con

Amylyx Pharmaceuticals reported its first quarter 2023 financial results, indicating a product revenue of $71.4 million, a significant increase from the previous quarter. The commercial launches of its ALS treatments, RELYVRIO in the U.S. and ALBRIOZA in Canada, are progressing positively, with expectations of broad access from payors. The company is also expanding its pipeline with plans for new studies in Wolfram syndrome and progressive supranuclear palsy. Regulatory reviews are ongoing in the EU regarding AMX0035, with expected decisions later this year.

Mar 13, 2023

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results • Full year product revenue of $22.2 million; commercial launches of RELYVRIO in U.S. and ALBRIOZA in Canada continue to progress

Amylyx Pharmaceuticals announced its financial results for 2022, revealing product revenue of $22.2 million driven by the launches of RELYVRIO in the U.S. and ALBRIOZA in Canada. The company is actively engaging with the EU for the review of its Marketing Authorisation Application for AMX0035, which aims to support ALS patients. Amidst these advancements, Amylyx faces notable financial challenges and a significant net loss reported for the year. The recent appointment of Karen Firestone to the Board of Directors intends to bolster strategic direction as the company continues to navigate its growth.

Nov 10, 2022

Amylyx Pharmaceuticals Reports Third Quarter 2022 Financial Results ˗ RELYVRIO (sodium phenylbutyrate and taurursodiol) approved for the treatment of ALS in adults and now commercially available in the U.S., repres

Amylyx Pharmaceuticals Reports Third Quarter 2022 Financial Results RELYVRIO (sodium phenylbutyrate and taurursodiol) approved for the treatment of ALS in adults and now commercially available in the U.S., representing second product launch for Amylyx worldwide Commercial launc

Sep 29, 2022

Amylyx Pharmaceuticals Announces FDA Approval of RELYVRIO for the Treatment of ALS RELYVRIO (previously known as AMX0035 in the U.S.) is an oral, fixed-dose combination therapy for the treatment of adults with ALS RELYVR

Amylyx Pharmaceuticals Announces FDA Approval of RELYVRIO for the Treatment of CAMBRIDGE, Mass. September 29, 2022 Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) ( Amylyx or the Company ) today announced that the U.S. Food and Drug Administration (FDA) has approved RELYVRIO (sodiu

Aug 11, 2022

Amylyx Pharmaceuticals Reports Second Quarter 2022 Financial Results - ALBRIOZA (also known as AMX0035) now commercially available in Canada, representing first product launch for Amylyx - FDA Advisory Committee meeting

Amylyx Pharmaceuticals Reports Second Quarter 2022 Financial Results - ALBRIOZA (also known as AMX0035) now commercially available in Canada, representing first product launch for Amylyx - FDA Advisory Committee meeting to review new drug application for AMX0035 for the treat

Jul 5, 2022

Amylyx Pharmaceuticals Announces FDA Plan to Reconvene Advisory Committee to Review AMX0035 NDA for the Treatment of ALS on

Amylyx Pharmaceuticals Announces FDA Plan to Reconvene Advisory Committee to Review AMX0035 NDA for the Treatment of ALS on September 7, 2022 CAMBRIDGE, Mass. July 5, 2022 Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) ( Amylyx or the Company ) today announced that the U.S. Food

Jun 13, 2022

Amylyx Pharmaceuticals Announces Health Canada Approval of ALBRIOZA for the Treatment of ALS Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ALS approved in

Amylyx Pharmaceuticals Announces Health Canada Approval of ALBRIOZA for the Mass. June 13, 2022 Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) ( Amylyx or the Company ) today announced that Health Canada has approved ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine), with co

Jun 3, 2022

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Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS New PDUFA goal date scheduled for

Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS CAMBRIDGE, Mass. June 3, 2022 Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) ( Amylyx or the Company ) today announced that the U.S. Food and Drug Administration (FDA) has ext

May 12, 2022