ACADIA Pharmaceuticals (NASDAQ:ACAD) reported third-quarter 2026 revenue of $342 million, up 22% from a year earlier on an adjusted basis, as demand for its Rett syndrome treatment DAYBUE and Parkinson’s disease psychosis drug NUPLAZID drove growth.
The company raised its full-year DAYBUE sales outlook and narrowed its NUPLAZID forecast. It also outlined changes to a late-stage study of remlifanserin in Alzheimer’s disease psychosis after the drug narrowly missed the primary endpoint in a phase II trial.
DAYBUE Sales Rise as STIX Adoption Grows
DAYBUE generated record quarterly net sales of $140 million, an increase of 39% year over year. Chief Commercial Officer Tom Garner said almost all of the growth came from volume, with the STIX formulation the predominant contributor.
More than half of U.S. DAYBUE patients were receiving STIX by the end of the quarter. The formulation is attracting new patients and some who had previously stopped treatment, Garner said. He added that more than 80% of patients who had discontinued DAYBUE had yet to retry it as STIX.
Asked whether STIX had improved tolerability, Garner said the company was monitoring the formulations closely and that treatment persistence appeared fairly similar so far. Families have reported that the lower volume of STIX reduces administration time, he said.
ACADIA raised and narrowed its full-year global DAYBUE net sales guidance to $505 million to $520 million. CEO Catherine Owen Adams reiterated the company’s ambition to reach $700 million in DAYBUE sales by the end of 2028.
The European Commission approved DAYBUE during the quarter for neurobehavioral symptoms of Rett syndrome, and ACADIA launched it in Germany in early October. The company plans to submit reimbursement dossiers for other key European markets before year-end.
ACADIA also received a U.S. patent notice of allowance covering the weight-banded dosing regimen used in both DAYBUE formulations. Following issuance and with pediatric exclusivity, the patent is expected to provide U.S. protection through March 2041, nearly five years longer than prior protections. Adams said the company is pursuing the same patent in Europe and expects to revisit its peak-sales outlook for DAYBUE in the first quarter of 2027.
NUPLAZID Growth and Financial Outlook
NUPLAZID net sales reached $202 million, up 12% on an adjusted basis, with 11% attributable to volume growth, according to Garner. The company narrowed its full-year sales guidance for the drug to $760 million to $775 million, citing the timing of benefits from an expanded sales force.
Garner said the field-force investment had more than doubled ACADIA’s reach to over 10,000 physicians. The company expects to realize the full benefit of that expansion through the end of 2026 and into 2027. Management maintained its ambition to reach approximately $1 billion in NUPLAZID net sales by the end of 2028.
Chief Financial Officer Mark Schneyer said ACADIA expects total 2026 revenue of $1.265 billion to $1.295 billion. Third-quarter research and development expenses fell to $76 million from $88 million a year earlier, while selling, general and administrative expenses rose to $159 million from $133 million. Cash stood at $976 million at quarter-end.
During the question-and-answer session, Schneyer said ACADIA remained confident in its position in an appeal involving a NUPLAZID patent, citing the company’s district court win last year. He declined to discuss details ahead of oral arguments.
Remlifanserin Trial Changes and Pipeline Updates
In the phase II portion of the RADIANT study of remlifanserin for Alzheimer’s disease psychosis, the primary endpoint narrowly missed statistical significance, with a p-value of 0.0603. Dr. Sanjeev Pathak, ACADIA’s head of clinical development, said the 60-milligram dose showed activity across four psychosis scales and that a key secondary endpoint achieved nominal statistical significance.
ACADIA plans to drop the 30-milligram dose from the phase III Alzheimer’s program and continue with 60 milligrams. It also plans to refine site selection, expand the use of central raters and modify its statistical plan. Pathak said disease severity would be considered in the statistical modifications, but the company does not plan to change the study’s inclusion or exclusion criteria.
Pathak said the preferred primary endpoint will remain SAPS-H+D, subject to discussions with the Food and Drug Administration in the first quarter of 2027. The company expects to present additional phase II findings at the CTAD conference later this month.
ACADIA expects phase II results for remlifanserin in Lewy body dementia psychosis in the fourth quarter of 2027. That study will continue to evaluate both 30-milligram and 60-milligram doses.
For ACP-211, an experimental oral treatment for major depressive disorder, the company expects phase II results in the second half of 2027. Pathak said the study is intended to assess efficacy, dose response and safety, among other factors.
About ACADIA Pharmaceuticals (NASDAQ:ACAD)
ACADIA Pharmaceuticals Inc is a biopharmaceutical company focused on developing and commercializing medicines for central nervous system and neuropsychiatric disorders. The company’s research programs target conditions with significant unmet medical needs, including neurological and rare neurodevelopmental diseases.
ACADIA’s commercial products include NUPLAZID (pimavanserin), an atypical antipsychotic approved in the United States to treat hallucinations and delusions associated with Parkinson’s disease psychosis.
