Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) posted better-than-expected fourth-quarter results on Tuesday, but shares declined more than 3% in premarket trading as investors assessed the company’s regulatory and commercialization outlook.
The biotech reported a quarterly loss of $0.30 per share, narrower than the analyst consensus estimate of a $0.34 loss. Revenue was not disclosed for the quarter. For full-year 2025, Amylyx posted a net loss of $1.53 per share, improving significantly from a loss of $4.43 per share in 2024.
The company also announced that patient recruitment has been completed for its pivotal Phase 3 LUCIDITY trial evaluating avexitide in post-bariatric hypoglycemia (PBH). Management said the final eligible participants are expected to be randomized and dosed this month, with topline data projected for the third quarter of 2026. If the therapy gains approval, Amylyx is targeting a commercial launch in 2027.
“2025 was a year of meaningful advancement for Amylyx’s pivotal avexitide program in post-bariatric hypoglycemia, as well as progress across our broader pipeline,” said Co-CEOs Joshua Cohen and Justin Klee. “With recruitment of LUCIDITY complete, we are on track to complete enrollment this month and continue to expect topline data in Q3 2026.”
Operating expenses declined year over year. Research and development costs fell to $21.2 million in the fourth quarter from $22.9 million a year earlier, reflecting lower spending on AMX0035 development for ALS and PSP, partially offset by increased investment in avexitide trials. Selling, general and administrative expenses decreased to $15.4 million from $17.1 million in the prior-year period.
As of December 31, 2025, Amylyx held $317.0 million in cash, cash equivalents and short-term investments, down from $344.0 million at the end of the third quarter. The company said its current cash position is expected to fund operations into 2028, including preparations for a potential avexitide launch.