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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 Q2 2026 results showing continued investment in its rare-disease pipeline and a net loss driven by research and pre-commercial activities. Operating expenses for the quarter were $45,693 thousand, including research and development of $23,768 thousand and selling, general and administrative costs of $21,925 thousand.
The company ended June 30, 2026 with $250.8 million in cash, cash equivalents and marketable securities and states this should fund operations into 2028. Its lead asset avexitide is in the Phase 3 LUCIDITY trial for post-bariatric hypoglycemia, with last-participant 16-week visits complete and topline data expected in the third quarter of 2026. Additional programs include AMX0035 in Wolfram syndrome, AMX0114 in ALS, and AMX0318 in IND-enabling studies. Amylyx also agreed in principle to settle a securities class action for $6.5 million, with a significant portion funded by insurance proceeds, while related derivative actions remain under negotiation.
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. insider Gina Mazzariello, Chief Legal Officer, reported two open-market sales of common stock. On July 9, 2026, she sold 15,000 shares at a weighted average price of $18.3164 per share, and on July 10, 2026 she sold another 15,000 shares at a weighted average price of $17.6081 per share. The filing states that these sales were effected pursuant to a Rule 10b5-1 trading plan adopted on April 9, 2026. Following the transactions, she holds 179,090 shares of Amylyx Pharmaceuticals common stock directly.
Amylyx Pharmaceuticals director Bernhardt G. Zeiher received a grant of 24,372 stock options. These options give the right to buy 24,372 shares of Amylyx common stock at an exercise price of $14.31 per share and expire on June 3, 2036.
According to the terms, the options vest in full on the earlier of June 4, 2027 or the date of the next annual meeting, as long as the director remains in continuous service with the company through that vesting date. After this grant, the director holds 24,372 derivative securities directly.
Amylyx Pharmaceuticals director Karen Firestone received a grant of stock options covering 24,372 shares of common stock at an exercise price of $14.31 per share. These options vest in full on the earlier of June 4, 2027 or the next annual meeting, provided she remains in continuous service, and bring her directly held option position reported in this filing to 24,372 shares.
Amylyx Pharmaceuticals director Daphne Quimi received a stock option grant covering 24,372 shares of Common Stock. The option has an exercise price of $14.31 per share and expires on June 3, 2036. It vests in full on the earlier of June 4, 2027 or the next annual meeting, subject to her continuous service, and represents her entire reported option position in this filing.
Amylyx Pharmaceuticals director George M. Milne Jr. received a grant of stock options covering 24,372 shares of common stock. The options have an exercise price of $14.31 per share and expire on June 3, 2036. They vest in full on the earlier of June 4, 2027 or the next annual meeting, as long as he continues serving the company.
Amylyx Pharmaceuticals director Paul R. Fonteyne received a grant of stock options covering 24,372 shares of common stock. The options have an exercise price of $14.31 per share and were awarded at no cost to him as compensation.
These options vest in full on the earlier of June 4, 2027 or the date of the next annual meeting, as long as he continues serving the company through that date. After this grant, he holds 24,372 stock options directly.