Amylyx Pharmaceuticals, Inc. (AMLX)
NASDAQHealth CareBiotechnologySnapshot 2026-09-04
NASDAQHealth CareBiotechnologySnapshot 2026-09-04
QuarterlyIQ Insights · AMLX
Material updates from SEC filings (8-K, 10-Q, 10-K) ranked by impact, with no firehose noise.
Entry into a Material Definitive Agreement. On August 19, 2026, Amylyx Pharmaceuticals, Inc. (“Amylyx” or the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC, Morgan Stanley & Co. LLC, Guggenheim Securities, LLC, and LifeSci Capital LLC, as representatives of the several underwriters named therein (the “Underwriters”), relating to the issuance and sale of an aggregate of 14,090,000 shares (the “Firm Shares”) of the Company’s common st…
Other Events On August 18, 2026, the Company announced positive topline results from LUCIDITY, a 78-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide, an investigational, first-in-class glucagon-like peptide-1 (“GLP-1”) receptor antagonist, in participants with post-bariatric hypoglycemia (“PBH”) following Roux-en-Y gastric bypass (“RYGB”) surgery. LUCIDITY met the Food and Drug Administration (the “FD…
Results of Operations and Financial Condition. On August 6, 2026, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Form 8-K”). The information provided in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (th…
Results of Operations and Financial Condition. On May 7, 2026, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Form 8-K”). The information provided in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the…
Results of Operations and Financial Condition. On March 3, 2026, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and fiscal year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Form 8-K”). The information provided in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1…
of this Current Report on Form 8-K and in Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing by the Company, under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. F…
Other Events On January 8, 2026, Amylyx Pharmaceuticals, Inc. (the “Company”) announced the selection of AMX0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia and other rare diseases. AMX0318 was identified through a research collaboration with Gubra A/S (“Gubra”), a company specializing in peptide-based drug discovery and preclinical contract research services. Under the terms of the research collaboration, Gubr…
Results of Operations and Financial Condition. On November 6, 2025, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2025. A copy of the press release is furnished as Exhibit 99.1 hereto. The information provided in this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subjec…
Entry into a Material Definitive Agreement. On September 9, 2025, Amylyx Pharmaceuticals, Inc. (“Amylyx” or the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (the “Underwriters”), relating to the issuance and sale of an aggregate of 17,500,000 shares (the “Firm Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stoc…
Results of Operations and Financial Condition. On August 7, 2025, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended June 30, 2025. A copy of the press release is furnished as Exhibit 99.1 hereto. The information provided in this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to th…
Results of Operations and Financial Condition. On May 8, 2025, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 2025. A copy of the press release is furnished as Exhibit 99.1 hereto. The information provided in this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the…
Results of Operations and Financial Condition. On March 4, 2025, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and fiscal year ended December 31, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information provided in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (…
Entry into a Material Definitive Agreement. On January 10, 2025, Amylyx Pharmaceuticals, Inc. (“Amylyx” or the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC, as representative of the several underwriters named therein (the “Underwriter”), relating to the issuance and sale of an aggregate of 17,142,857 shares (the “Firm Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stock”), at a price to the public of $…
of this Current Report on Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing by the Company, under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. Forward-Looking Statements Statements…
Results of Operations and Financial Condition. On November 7, 2024, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2024. A copy of the press release is furnished as Exhibit 99.1 hereto. The information provided in this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subjec…
Other Events. On October 17, 2024, Amylyx Pharmaceuticals, Inc. (the “Company”) 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 a…
Results of Operations and Financial Condition. On August 8, 2024, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended June 30, 2024. A copy of the press release is furnished as Exhibit 99.1 hereto. The information provided in this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to th…
Completion of Acquisition or Disposition of Assets. As previously disclosed, on June 21, 2024, Amylyx Pharmaceuticals, Inc., a Delaware corporation (“Amylyx” or the “Company”), and Eiger BioPharmaceuticals, Inc., a Delaware corporation (the “Seller”), entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”), pursuant to which the Company agreed to acquire substantially all of the Seller’s rights, title and interests in, to and under those assets and interests used by the Sell…
Entry Into a Material Definitive Agreement On June 21, 2024, Amylyx Pharmaceuticals, Inc., a Delaware corporation (the “Company”), entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Eiger BioPharmaceuticals, Inc., a Delaware corporation (the “Seller”), pursuant to which, subject to the terms and conditions set forth in the Asset Purchase Agreement, the Company agreed to acquire substantially all of the Seller’s rights, title, and interests in, to and under those as…
Results of Operations and Financial Condition. On May 9, 2024, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 2024. A copy of the press release is furnished as Exhibit 99.1 hereto. The information provided in this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the…
Other Events. On April 10, 2024, Amylyx Pharmaceuticals, Inc. (the “Company”) 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…
Costs Associated with Exit or Disposal Activities On April 3, 2024, the board of directors of Amylyx Pharmaceuticals, Inc. (the “Company”) approved a restructuring plan designed to focus the Company’s resources on key clinical and preclinical programs (the “Restructuring Plan”). The Restructuring Plan includes a reduction in force which is expected to reduce the Company’s workforce by approximately 70% and a decrease in external financial commitments outside of its priority areas. The Company…
Other Events. On April 4, 2024, the Company announced it has started a process with the U.S. Food and Drug Administration and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO®/ALBRIOZA ™ 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 th…
Director — Bernhardt Zeiher, MD, FCCP, FACP: Dr. Bernhardt Zeiher was appointed as a Class I director and will serve on the Nominating and Corporate Governance Committee.
Other Events. On March 8, 2024, the Company 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 Amyotrop…
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