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.
Acadia Pharmaceuticals (NASDAQ: ACAD) generates news flow typical of a commercial-stage biopharmaceutical company focused on central nervous system disorders. As a CNS-focused biotech, Acadia's announcements span FDA regulatory decisions, clinical trial results, quarterly earnings reports, and pipeline development updates.
Clinical trial readouts represent significant news events for Acadia, as Phase 2 and Phase 3 study results determine whether drug candidates advance toward potential approval. COMPASS and LOTUS studies exemplify the types of clinical programs that generate data presentations at medical conferences and subsequent news coverage analyzing implications for the company's pipeline.
FDA interactions produce material announcements including new drug application submissions, complete response letters, and approval decisions. For a company concentrated in CNS therapeutics, regulatory milestones carry particular weight given the complexity of developing treatments for neurological and psychiatric conditions.
Quarterly earnings reports reveal commercial product performance, pipeline investment levels, and cash position updates. As Acadia balances commercial revenue against research and development spending, earnings calls provide insight into the sustainability of this business model and management's capital allocation priorities.
Executive appointments and governance changes reflect Acadia's organizational development as it expands commercial and clinical capabilities. R&D Day events and investor presentations offer deeper visibility into scientific strategy and long-term pipeline direction.
Bookmark this page to follow Acadia's clinical development progress, regulatory interactions, and commercial performance in the CNS therapeutics space.
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.
Acadia Pharmaceuticals (NASDAQ: ACAD) announced inducement grants to eighteen new employees under its 2024 Inducement Plan. The grants include non-qualified stock options for 161,676 shares at $25.50 per share and 49,363 restricted stock units (RSUs).
The stock options will vest over four years, with 25% vesting after one year and the remainder monthly over 36 months. The RSUs will vest over four years, with 50% vesting after two years and the remaining 50% in two equal annual installments. All grants are subject to continued employment with Acadia.
Acadia is known for developing the first FDA-approved treatment for Parkinson's disease psychosis and Rett syndrome in the US and Canada. The company continues to focus on neuroscience and neuro-rare diseases, including programs for Prader-Willi syndrome and Alzheimer's disease psychosis.
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