Acadia Q3 Revenue Rises 22% as DAYBUE Sales Jump 39%

Acadia (ACAD) reported third-quarter 2026 revenue of $342.3 million, up 22% from the adjusted year-earlier figure, as strong DAYBUE growth and higher NUPLAZID volume supported both commercial franchises. The company increased its full-year DAYBUE sales guidance, narrowed its NUPLAZID forecast and reduced its expected 2026 research and development spending.

DAYBUE net product sales rose 39% year over year to $140.1 million from $101.1 million, driven primarily by volume growth in the U.S. Acadia said the STIX formulation contributed through new patient starts and restarts, with more than half of U.S. DAYBUE patients now receiving STIX.

The company also began commercial sales of trofinetide in Germany following European Commission approval under the DAYBU brand. Patients are already receiving treatment, and Acadia plans to submit reimbursement dossiers in additional European countries during 2026. DAYBUE and its related trofinetide formulations are approved in the U.S., Canada, Israel and the European Union for specified Rett syndrome populations.

Acadia also received a new U.S. patent allowance that it said extends DAYBUE protection through March 2041, nearly five years beyond the previous loss-of-exclusivity timeline.

NUPLAZID volume supports growth

NUPLAZID generated third-quarter sales of $202.2 million, a 12% increase from adjusted sales of $179.8 million a year earlier. The presentation attributed the increase primarily to volume, supported by new-brand prescription trends, expanded sales-force engagement with healthcare professionals and direct-to-consumer investment intended to increase awareness of Parkinson’s disease psychosis.

The year-over-year comparisons use non-GAAP adjusted third-quarter 2025 NUPLAZID sales and total revenue. Acadia excluded an unusual, non-recurring adjustment related to a change in its estimate of Inflation Reduction Act rebate accruals. Reported GAAP NUPLAZID sales for the prior-year quarter were $177.5 million.

Research and development expense declined 13% to $76.3 million, while selling, general and administrative expense increased 19% to $159.2 million. Diluted earnings per share were $0.31, compared with $0.42 in the third quarter of 2025. Acadia ended the quarter with $976.4 million in cash and investments.

DAYBUE guidance increased

Acadia now expects 2026 DAYBUE net sales of $505 million to $520 million, compared with its previous range of $480 million to $510 million. The forecast includes contributions from named-patient supply programs outside the U.S.

The company narrowed its NUPLAZID sales guidance to $760 million to $775 million from $760 million to $790 million. Total 2026 revenue is expected to be between $1.265 billion and $1.295 billion, compared with the prior range of $1.24 billion to $1.30 billion.

Acadia lowered its expected R&D expense range to $325 million to $340 million from $355 million to $380 million. SG&A expense is projected at $665 million to $685 million, versus the previous range of $660 million to $700 million. All full-year guidance figures are presented on a GAAP basis.

Remlifanserin advances despite primary endpoint miss

In its pipeline update, Acadia said Phase 2 RADIANT data support continued development of the investigational drug remlifanserin in Alzheimer’s disease psychosis. The 60 mg dose narrowly missed the study’s primary SAPS H+D endpoint, producing a difference of minus 2.2 points versus placebo at week six, with a nominal p-value of 0.0603.

The dose showed nominally significant results on the key secondary CGI-S endpoint and other secondary psychosis measures. Acadia also reported a favorable safety and tolerability profile, with no new safety signals, no observed QT-prolongation signal versus placebo and low rates of serious adverse events and treatment discontinuations.

The company selected the 60 mg dose for two ongoing Phase 3 trials and dropped the 30 mg arm. Protocol changes include refined site selection, expanded use of central raters and modifications to the prespecified statistical plan, while inclusion criteria remain unchanged.

Acadia expects results from the Phase 2 ILLUMERA study of remlifanserin in Lewy body dementia psychosis in the fourth quarter of 2027. Results from the Phase 2 NORLIGHT study of ACP-211 in major depressive disorder are expected in the second half of 2027. Both candidates remain investigational and are not approved by any regulatory authority.

The company’s outlook depends on continued commercialization of DAYBUE and NUPLAZID, regulatory progress for its pipeline and execution of its development programs. Acadia also identified competition, reliance on third-party manufacturers and distributors, commercialization and clinical-development costs, intellectual-property protection and its ability to meet financial guidance among the principal uncertainties facing the business.