Acadia Pharmaceuticals Inc. develops and commercializes therapies for neurological and rare diseases. Its commercial portfolio includes NUPLAZID (pimavanserin) for hallucinations and delusions associated with Parkinson’s disease psychosis and DAYBUE (trofinetide), including DAYBUE STIX, for Rett syndrome.
Company news commonly covers product revenue from NUPLAZID and DAYBUE, formulation and launch updates for trofinetide, clinical and scientific presentations across neurological disorders, pipeline work in Alzheimer’s disease psychosis, Lewy body dementia psychosis and essential tremor, investor-conference participation, and board or research-and-development leadership changes.
Acadia Pharmaceuticals (ACAD) reported oral arguments in the Federal Circuit appeal concerning its NUPLAZID formulation patent, following a favorable district court judgment.
The May 2025 judgment upheld the patent covering the 34 mg capsule formulation. Acadia expects an appeal decision in the first half of 2027, although no ruling timeline is set. The company expects formulation protection through February 2038 if the judgment is upheld; otherwise, it expects protection through October 2030 under the previously upheld composition of matter patent and associated pediatric exclusivity.
Acadia also expects NUPLAZID to face a negotiated price under the Inflation Reduction Act beginning in 2029.
Acadia Pharmaceuticals (ACAD) will present remlifanserin and Alzheimer’s disease psychosis research at the CTAD conference in Boston on November 16–19, 2026.
An oral presentation on November 17 at 9:35 a.m. ET will feature efficacy and safety findings from the Phase 2 portion of the ongoing RADIANT program. A poster on November 18 will examine biomarker differences among patients meeting clinical criteria for Alzheimer’s disease psychosis.
RADIANT is a randomized, double-blind, placebo-controlled Phase 2 and 3 program evaluating remlifanserin for associated hallucinations and delusions. Its Phase 2 portion was designed to evaluate 60 mg and 30 mg once-daily doses against placebo. Participants completing any RADIANT study may enter a long-term open-label extension, in which treatment is known to participants and researchers.
Acadia Pharmaceuticals (Nasdaq: ACAD) reported third-quarter 2026 revenue of $342 million, up 22% against adjusted revenue a year earlier. DAYBUE sales rose 39% to $140 million; NUPLAZID sales rose 12% against adjusted prior-year sales to $202 million. GAAP net income fell to $0.31 per diluted share from $0.42.
Acadia raised 2026 DAYBUE sales guidance to $505–$520 million and narrowed total revenue guidance to $1.265–$1.295 billion. NUPLAZID guidance narrowed to $760–$775 million; R&D guidance fell to $325–$340 million, while SG&A guidance narrowed to $665–$685 million. Cash and investments reached $976 million, versus $820 million at year-end 2025.
DAYBU received European approval and launched in Germany. A new U.S. patent allowance extends DAYBUE protection through March 2041. Acadia plans continued Phase 3 development of remlifanserin and expects two Phase 2 readouts in 2027.
Acadia Pharmaceuticals (ACAD) will participate in a fireside chat at the UBS Global Biopharma Conference on November 17, 2026. The chat is scheduled for 12:40 p.m. Greenwich Mean Time. A live webcast will be available in the investors section of acadia.com, with an archived recording accessible for approximately one month following the presentation.
Acadia Pharmaceuticals (ACAD) will report its third quarter 2026 financial results on November 4, 2026, after U.S. financial markets close. Management will host a conference call and webcast at 4:30 p.m. Eastern Time that day. The webcast will be available through the investors section of acadia.com and archived for approximately 90 days.
Acadia Pharmaceuticals (ACAD) received a U.S. Notice of Allowance for a patent covering weight-banded trofinetide dosing in Rett syndrome.
The U.S. Patent and Trademark Office determined that application No. 17/590,496 meets patentability requirements, but the patent has not yet issued. It is expected to issue after standard administrative steps. Following issuance, and including six months of pediatric exclusivity, the patent is expected to protect trofinetide in the United States through March 28, 2041. An existing Rett syndrome method-of-use patent expires in July 2036.
Acadia Pharmaceuticals (ACAD) reported Phase 2 RADIANT results for remlifanserin in Alzheimer’s disease psychosis on September 24, 2026.
At week 6, hallucination and delusion scores changed by -12.6 from baseline with the 60 mg once-daily dose versus -10.4 with placebo on the primary SAPS-H+D measure. The endpoint narrowly missed statistical significance (p=0.0603). On the key secondary CGI-S-ADP severity measure, scores changed by -1.3 versus -0.9 with placebo, with nominal significance (p=0.0077). The 30 mg dose showed minimal improvement versus placebo across endpoints.
Rates of adverse events, serious adverse events and discontinuations due to adverse events were similar to placebo across both doses. No deaths occurred in the remlifanserin arms. Acadia plans to continue enrollment in two ongoing Phase 3 studies while amending the program to remove the 30 mg arm.
Acadia Pharmaceuticals (Nasdaq: ACAD) announced that the European Commission has granted marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and children aged five years and older. This makes DAYBU the first and only approved treatment for Rett syndrome in the European Union.
The approval is primarily based on the Phase 3 LAVENDER study, which showed statistically significant and clinically meaningful improvements on the RSBQ and CGI-I co-primary endpoints. DAYBU is now authorized for marketing in all 27 EU member states plus Iceland, Liechtenstein, and Norway. Acadia will next begin pricing and reimbursement negotiations with national authorities to potentially make DAYBU available to patients across these countries.
Acadia Pharmaceuticals (Nasdaq: ACAD) reported second quarter 2026 GAAP total revenues of $308 million, up 16% year-over-year and 17% versus non-GAAP adjusted 2Q25. NUPLAZID® GAAP net sales were $183 million (up 9% vs GAAP, 10% vs non-GAAP), and DAYBUE® net sales were $125 million, up 30% year-over-year, driven by strong uptake of DAYBUE STIX.
Net income was $31.5 million, or $0.18 per diluted share, compared to $26.7 million and $0.16 a year ago. Cash, cash equivalents and investment securities rose to $956 million from $820 million at year-end 2025. Acadia raised 2026 total revenue guidance to $1.24–$1.30 billion, increased DAYBUE guidance to $480–$510 million, reaffirmed NUPLAZID guidance of $760–$790 million, and lowered R&D expense guidance to $355–$380 million. The company completed Phase 2 enrollment and started Phase 3 screening for remlifanserin in Alzheimer’s disease psychosis, obtained FDA Fast Track designation, and received a positive CHMP opinion recommending EU approval for DAYBU.
Acadia Pharmaceuticals (Nasdaq: ACAD) will participate in a fireside chat at the Canaccord Genuity 46th Annual Growth Conference on Wednesday, August 12, 2026 at 1:30 p.m. Eastern Time. A live webcast and a one‑month archive will be available in the investors section of acadia.com.