Acadia reports Q3 2026 results, Phase 3-enabling data for remlifanserin in Alzheimer's psychosis
Acadia raised full-year DAYBUE sales guidance and reported positive Phase 2 RADIANT results supporting Phase 3 development of remlifanserin in Alzheimer's disease psychosis.
Acadia Pharmaceuticals announced financial results for the third quarter ended September 30, 2026 on November 4, 2026.
The company said topline results from the Phase 2 RADIANT study of remlifanserin in Alzheimer's disease psychosis showed consistent efficacy trends at the 60 mg dose across all four psychosis scales assessed for the full study population, along with a favorable safety and tolerability profile that the company said supports continued and optimized Phase 3 development.1 Additional data will be presented at the Clinical Trials on Alzheimer's Disease conference on November 17, 2026, in Boston.1
Acadia also provided new guidance for its pipeline: it expects two Phase 2 readouts in 2027, with ACP-211 in major depressive disorder expected in the second half of the year and, for the first time, remlifanserin in Lewy body dementia psychosis (LBDP) guided for the fourth quarter.1 The FDA granted Fast Track designation for remlifanserin in the treatment of Lewy body dementia psychosis, citing significant unmet need for new treatment options.1
On intellectual property, Acadia said it received allowance of a new U.S. patent covering weight-banded dosing of trofinetide, extending U.S. patent protection for DAYBUE and DAYBUE STIX by nearly five years, through March 2041.1
In Europe, the company said DAYBU (trofinetide) received approval from the European Commission in August 2026 as a treatment for neurobehavioral symptoms of Rett syndrome in adults and children aged five and older, and that the product launched in Germany in early October 2026, with patients already receiving the commercial product, according to the company.
Acadia also said it completed a Phase 3 study of trofinetide in Rett syndrome in Japan, with results it described as consistent with the earlier LAVENDER Phase 3 study, and that it is seeking a distribution partner ahead of a planned regulatory filing in 2027 and a potential launch in 2028, pending approval.
The company raised 2026 guidance: total revenues are now expected between $1.265 and $1.295 billion, up from a prior range of $1.24 to $1.30 billion, while DAYBUE net product sales guidance rose to $505 to $520 million from $480 to $510 million.1 Cash, cash equivalents and investment securities totaled $976 million at September 30, 2026, compared with $820 million at December 31, 2025.1
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