Welcome to our dedicated page for Acadia Pharmaceuticals news (Ticker: ACAD), a resource for investors and traders seeking the latest updates and insights on Acadia Pharmaceuticals stock.
News and updates for Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) focus on its activities in neurological and rare diseases, including commercial performance and clinical development. Company press releases highlight revenue trends from its marketed medicines NUPLAZID for hallucinations and delusions associated with Parkinson’s disease psychosis and DAYBUE for Rett syndrome, as well as guidance ranges for total revenues and net product sales.
Investors following ACAD news can see announcements of quarterly financial results, participation in major healthcare and investor conferences, and business updates presented at events such as the J.P. Morgan Healthcare Conference. These updates often describe how NUPLAZID and DAYBUE are performing commercially and how Acadia views the growth outlook for its neurology and neuro‑rare franchises.
Acadia’s news flow also covers regulatory and clinical milestones. Examples include U.S. Food and Drug Administration approval of DAYBUE STIX, a powder formulation of trofinetide for oral solution for Rett syndrome in adults and pediatric patients 2 years of age and older, approval of DAYBUE oral solution by the Ministry of Health in Israel, and progress toward regulatory opinions and late‑stage studies for trofinetide in other regions. The company issues updates on its pipeline, such as timelines for Phase 2 and Phase 3 trials of remlifanserin (ACP‑204) in Alzheimer’s disease psychosis and Lewy body dementia psychosis, and data presentations on ACP‑711 and NUPLAZID at scientific congresses.
Readers of this ACAD news page can use it to track Acadia’s financial disclosures, regulatory approvals, clinical trial readouts, and strategic commentary from management over time. The news archive provides context on how the company’s commercial portfolio and pipeline in central nervous system and neuro‑rare diseases are evolving.
Acadia Pharmaceuticals (Nasdaq: ACAD) provided business and pipeline updates at the 44th J.P. Morgan Healthcare Conference on January 13, 2026. Management reiterated a 2028 projected combined net sales of ~$1.7 billion (NUPLAZID ~ $1.0B; DAYBUE ~ $0.7B). Key near‑term catalysts include top‑line Phase 2 RADIANT results for remlifanserin expected Aug–Oct 2026 and multiple regulatory milestones for trofinetide (DAYBUE), including FDA approval of DAYBUE STIX (Dec 12, 2025) with limited U.S. availability in Q1 2026 and broader launch in Q2 2026.
Other items: Israel approval for DAYBUE oral solution, EMA CHMP opinion anticipated Q1 2026, Japan Phase 3 trofinetide readout expected Oct 2026–Mar 2027, and plans to initiate five Phase 2/3 studies with four readouts by end of 2027.
Acadia Pharmaceuticals (Nasdaq: ACAD) will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on January 13, 2026. Catherine Owen Adams, Chief Executive Officer, will speak on Tuesday, January 13, 2026 at 9:45 a.m. PT / 12:45 p.m. ET. A live webcast of the presentation will be available on the company website under Investors, with an archived recording accessible for approximately one month after the event.
Acadia’s commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome, and the company is developing mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis.
Acadia Pharmaceuticals (NASDAQ: ACAD) announced FDA approval of DAYBUE STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation for treating Rett syndrome in patients aged 2 years and older.
The approval is supported by a bioequivalence study showing comparable exposure to DAYBUE oral solution and relies on efficacy/safety from the LAVENDER study. DAYBUE STIX will launch on a limited basis in Q1 2026 and more broadly in early Q2 2026. The original oral solution will remain available.
Acadia Pharmaceuticals (Nasdaq: ACAD) will participate in a fireside chat at Citi’s 2025 Global Healthcare Conference on Tuesday, December 2, 2025 at 9:45 a.m. ET. A live webcast will be available on the company website under the Investors section, and an archived recording will be accessible for approximately one month after the presentation.
Acadia highlighted its commercial portfolio, including FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome, and noted mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, plus earlier-stage programs in other neurological and rare diseases.
Acadia Pharmaceuticals (NASDAQ: ACAD) reported Q3 2025 total revenues of $278.6M, up 11% year-over-year, driven by NUPLAZID sales of $177.5M (+12% YoY) and DAYBUE sales of $101.1M (+11% YoY). Net income was $71.8M ($0.42 diluted), versus $32.8M a year ago, reflecting higher pre-tax income and a one-time tax benefit from the One Big Beautiful Bill Act. Cash and investments totaled $847.0M at September 30, 2025. R&D expense rose to $87.8M for the quarter. Full-year 2025 guidance was updated: total revenues $1.070–$1.095B, NUPLAZID $685–$695M, DAYBUE $385–$400M, with R&D and SG&A ranges provided.
Acadia Pharmaceuticals (Nasdaq: ACAD) will participate at two investor conferences in November 2025.
UBS Global Healthcare Conference fireside chat: Monday, November 10, 2025 at 2:00 p.m. ET in Palm Beach Gardens, FL. Jefferies Global Healthcare Conference presentation: Tuesday, November 18, 2025 at 8:30 a.m. GMT in London.
Live webcasts will be accessible on Acadia’s investor website and archived recordings will be available for about one month after each presentation. The company described its commercial portfolio and mid‑ to late‑stage pipeline in neurological and rare disease programs, including treatments for Parkinson’s disease psychosis and Rett syndrome.
Acadia Pharmaceuticals (Nasdaq: ACAD) will report third quarter 2025 financial results on Wednesday, November 5, 2025 after U.S. market close. Management will host a conference call and webcast on November 5, 2025 at 4:30 p.m. Eastern Time.
The webcast will be available on Acadia's investor website and archived there until February 5, 2026. Registration provides dial-in number and unique PIN for the call. Acadia's commercial portfolio includes FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome, and the pipeline includes mid-to-late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis.
Acadia Pharmaceuticals (NASDAQ: ACAD) announced three presentations at the 2025 International Congress of Parkinson's Disease and Movement Disorders® in Honolulu. The presentations include: a late-breaker oral platform presentation on ACP-711 for essential tremor, showing preclinical efficacy and safety data; a poster on the Phase 2 study design of ACP-204 for Lewy body dementia psychosis; and findings from a post-hoc analysis of NUPLAZID® (pimavanserin) in Parkinson's disease psychosis.
NUPLAZID, approved by the FDA in April 2016, is indicated for treating hallucinations and delusions associated with Parkinson's disease psychosis. The drug selectively targets 5-HT2A receptors and carries important safety considerations, including warnings about increased mortality in elderly patients with dementia-related psychosis and QT interval prolongation.
Acadia Pharmaceuticals (Nasdaq: ACAD) announced disappointing results from its Phase 3 COMPASS PWS trial evaluating intranasal carbetocin (ACP-101) for hyperphagia in Prader-Willi syndrome. The trial failed to meet its primary endpoint, showing no statistically significant improvement over placebo on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) at Week 12.
The study, which enrolled 175 patients aged 5-30 years, also showed no separation from placebo on secondary endpoints, though the safety profile remained consistent with previous trials. Despite this setback, Acadia maintains a positive outlook, projecting over $1 billion in net sales for 2025 from two approved products and anticipates seven Phase 2 or 3 study starts through 2026 and four data readouts by 2027.
Acadia Pharmaceuticals (NASDAQ:ACAD) published interim results from the LOTUS study evaluating DAYBUE® (trofinetide) in Rett syndrome patients. The study, involving 227 patients aged 1-60 years, demonstrated significant effectiveness in real-world settings over 12 months.
Key findings showed 71-90% of patients reported behavioral improvements, with notable progress in nonverbal communication (48-71%), alertness (44-70%), and social interaction (33-58%). The study also provided insights into managing gastrointestinal symptoms, with diarrhea incidence varying between 23-50% in weeks 1-12 and 26-38% in months 4-12.
The median dose reached at least 80% of the labeled dose by Week 10, starting from 36% at Week 1. The Quality-of-Life assessment showed a median improvement of 4.6 points over 12 months.
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