Every 8-K that Amylyx Pharmaceuticals (AMLX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow AMLX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full AMLX filings page.
Amylyx Pharmaceuticals, Inc. (AMLX) announced an underwritten public offering of 14,090,000 shares of common stock at $35.50 per share, with underwriters granted a 30-day option to purchase up to an additional 2,113,500 shares at the public price less underwriting discounts and commissions.
Amylyx expects to receive aggregate net proceeds of approximately $471.7 million, or approximately $542.5 million if the option is fully exercised. The company intends to use the net proceeds, together with existing cash, cash equivalents and marketable securities, to fund the potential U.S. commercial launch of avexitide, if approved, including additional manufacturing capacity, and for research and development, working capital and other general corporate purposes. The offering is expected to close on August 21, 2026, subject to customary closing conditions.
Amylyx Pharmaceuticals, Inc. reported positive topline results from the Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia (PBH) after Roux-en-Y gastric bypass. The randomized, double-blind, placebo-controlled study in 78 participants met its FDA-agreed primary endpoint with a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events versus placebo (rate ratio 0.45, 95% CI 0.32–0.63, p=0.000003), and met all secondary endpoints. Avexitide was generally well-tolerated, with no treatment-related serious adverse events and mostly mild or moderate side effects. PBH currently has no approved therapies and affects an estimated ~160,000 people in the U.S. Amylyx plans an NDA submission to the FDA by the end of 2026 and is preparing for a potential commercial launch of avexitide in 2027, supported by orphan drug designation, expected NCE exclusivity, and patent rights through 2037 with potential extensions.
Amylyx Pharmaceuticals reported positive topline Phase 3 LUCIDITY results for avexitide, an investigational first-in-class GLP‑1 receptor antagonist for post-bariatric hypoglycemia (PBH) after Roux-en-Y gastric bypass. The 78-participant, randomized, double-blind, placebo-controlled trial met the FDA-agreed primary endpoint, showing a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events versus placebo through Week 16 (p=0.000003).
LUCIDITY also met all secondary endpoints, with highly statistically significant and clinically meaningful reductions in Level 2 and Level 3 events by both self-monitoring of blood glucose and continuous glucose monitoring. Avexitide 90 mg once daily was generally well tolerated, with mostly mild to moderate adverse events and no serious adverse events related to treatment, and no body-weight changes over 16 weeks. Amylyx plans to submit a New Drug Application by the end of 2026 and is preparing for a potential U.S. commercial launch in 2027, if approved. Avexitide already holds FDA Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug designations across PBH and congenital hyperinsulinism.
Amylyx Pharmaceuticals reported a second quarter 2026 net loss of $43.4 million, or $0.39 per share, compared with a net loss of $41.4 million, or $0.46 per share, a year earlier. Research and development expenses were $23.8 million, down from $27.2 million, while selling, general and administrative expenses rose to $21.9 million from $15.6 million, driven mainly by higher legal costs and commercial initiatives.
Cash, cash equivalents and short-term investments totaled $250.8 million as of June 30, 2026, versus $279.8 million at March 31, 2026, and the company expects its current cash runway to fund operations into 2028.
Operationally, the last participant has completed the final study visit in the pivotal Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia, with topline data anticipated in late August or early September 2026 and a potential U.S. commercial launch in 2027 if approved. Amylyx also advanced an expanded access program for avexitide, continued development of AMX0114 for ALS, progressed AMX0318 toward an IND targeted for 2027, and reported longer-term data for AMX0035 in Wolfram syndrome.
Amylyx Pharmaceuticals, Inc. reported the results of its annual stockholder meeting. Stockholders elected George Mclean Milne Jr., Ph.D. and Paul Fonteyne as Class II directors to serve until the 2029 annual meeting, with each nominee receiving more than 76 million votes for.
Stockholders also ratified Deloitte & Touche LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 102,036,295 votes for and minimal opposition. In a non-binding advisory vote, stockholders approved the compensation of the company’s named executive officers, with 77,534,824 votes for and 13,490,653 against.
Amylyx Pharmaceuticals reported a larger net loss while advancing its endocrine and neurodegenerative pipeline in the first quarter of 2026. The company posted a net loss of $41.3 million, or $0.37 per share, compared with a net loss of $35.9 million, or $0.42 per share, a year earlier.
Research and development expenses rose to $27.6 million, mainly from increased spending on avexitide for post-bariatric hypoglycemia and $4.0 million in milestone payments tied to AMX0318. Cash, cash equivalents, and short-term investments were $279.8 million at March 31, 2026, which the company expects to fund operations into 2028.
Amylyx completed enrollment in its 78-participant Phase 3 LUCIDITY trial of avexitide in PBH and expects topline data in the third quarter of 2026, with a potential commercial launch in 2027 if approved. The company is also progressing the AMX0114 ALS program and preclinical candidate AMX0318.
Amylyx Pharmaceuticals furnished an updated corporate presentation outlining progress across its rare disease pipeline and financial position. The company highlighted completion of enrollment in the Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia, with topline data expected in Q3 2026 and a potential commercial launch in 2027 if approved.
The presentation also noted completion of enrollment in Cohort 2 of the Phase 1 LUMINA trial of AMX0114 for ALS, positive Phase 2 HELIOS results for AMX0035 in Wolfram syndrome, and nomination of AMX0318 as a long-acting GLP-1 receptor antagonist development candidate. As of December 31, 2025, Amylyx reported $317 million in cash, cash equivalents, and short-term investments and approximately 110 million shares outstanding, with a cash runway expected into 2028 through the potential approval and launch of avexitide in 2027.
Amylyx Pharmaceuticals reported a smaller net loss for 2025 while pivoting firmly to late-stage development of avexitide for post-bariatric hypoglycemia (PBH). Net loss for 2025 was $144.7 million, or $1.53 per share, about half the $301.7 million, or $4.43 per share, loss in 2024. Product revenue fell from $87.4 million in 2024 to zero in 2025 as the company redirected resources.
Research and development expenses were $90.4 million in 2025, down from $104.1 million, while selling, general, and administrative expenses dropped sharply to $62.9 million from $114.3 million, reflecting reduced consulting and professional services. Cash, cash equivalents, and marketable securities were $317.0 million at December 31, 2025, up from $176.5 million a year earlier, supporting a stated cash runway into 2028.
Operationally, recruitment for the pivotal Phase 3 LUCIDITY trial of avexitide in PBH is complete, with last participants expected to be randomized and dosed in Q1 2026 and topline data anticipated in Q3 2026, targeting potential U.S. commercialization in 2027 if approved. The company is also advancing AMX0114 for amyotrophic lateral sclerosis in the Phase 1 LUMINA trial, with Cohort 2 enrollment expected to complete in March 2026, and progressing AMX0318 toward a planned investigational new drug filing in 2027.
Amylyx Pharmaceuticals reported that it has selected AMX0318, a long-acting GLP-1 receptor antagonist, as a new development candidate for treating post-bariatric hypoglycemia and other rare diseases. AMX0318 was discovered through a research collaboration with Gubra A/S, which specializes in peptide-based drug discovery and preclinical research.
Under this collaboration, Gubra is eligible to receive more than $50 million in success-based development and commercialization milestone payments, plus mid-single digit royalties on worldwide net sales if AMX0318 progresses successfully. The selection and handover of the development candidate immediately triggers $4 million in milestone payments to Gubra.
Amylyx also updated its corporate presentation for use with investors and analysts, furnishing the new presentation as Exhibit 99.1.
Amylyx Pharmaceuticals (AMLX) reported that it issued a press release announcing financial results for the fiscal quarter ended September 30, 2025. The press release is furnished as Exhibit 99.1 to this report.
The information in this item, including Exhibit 99.1, is being furnished and is not deemed filed for purposes of Section 18 of the Exchange Act, and is not incorporated by reference into other filings except as expressly set forth by specific reference.
Amylyx Pharmaceuticals filed a Current Report (Form 8-K) that includes an underwriting agreement dated September 9, 2025, and counsel materials from Goodwin Procter LLP. The filing discloses that an opinion and consent of Goodwin Procter LLP are included as exhibits, and that the cover page interactive data file is embedded within the Inline XBRL document. The report contains a standard forward-looking statements caution referencing prior SEC reports and urges investors not to rely solely on forward-looking statements. The filing is signed by James M. Frates, Chief Financial Officer, dated September 10, 2025.
Amylyx Pharmaceuticals reported a key setback in its neurology pipeline. The company is discontinuing the ORION program of AMX0035 (sodium phenylbutyrate and taurursodiol) in adults living with progressive supranuclear palsy after the treatment did not show differences compared to placebo on primary or secondary outcomes at Week 24.
As a result, Amylyx will stop the ongoing Phase 2b trial and its open-label extension and will not start the planned Phase 3 portion of the program. The company noted that safety data in this study were consistent with safety data from prior AMX0035 studies, indicating no new safety concerns despite the lack of efficacy in this indication.