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 has appointed Dr. Doug Williamson as Executive Vice President, Head of Research and Development. Dr. Williamson, succeeding Dr. Srdjan Stankovic, brings over 20 years of neuroscience R&D experience, most recently serving as Chief Medical Officer at Avadel Pharmaceuticals. His leadership is expected to play a crucial role as Acadia prepares for the potential approval of trofinetide for Rett syndrome and advances its clinical programs. This strategic move aims to strengthen Acadia's position in the neuroscience market during a pivotal time.
Acadia Pharmaceuticals announced positive findings from a retrospective analysis published in Drug Safety, indicating a lower mortality risk in Parkinson's disease psychosis (PDP) patients treated with NUPLAZID® (pimavanserin) compared to other atypical antipsychotics. The study, based on Medicare claims data, showed a hazard ratio for all-cause mortality of 0.78 for NUPLAZID. Results were consistent across various patient subgroups, including those in long-term care facilities. NUPLAZID remains the only FDA-approved treatment for PDP, highlighting its significance in managing this challenging condition.
Acadia Pharmaceuticals will present at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 9:00 a.m. PT. The presentation will include a live Q&A session and can be accessed via their website under the investors section. An archived recording will be available for one month post-event. Acadia has over 25 years in healthcare, focusing on breakthroughs in neuroscience, including therapies for Parkinson's disease psychosis and ongoing clinical developments for schizophrenia and Rett syndrome.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) will participate in two investor conferences. The first is the Guggenheim 4th Annual Immunology and Neurology Day on November 14, 2022, in New York, NY. The second is the J.P. Morgan Equity Opportunities Forum on November 15, 2022, in Miami, FL. A live webcast of Acadia's presentation at the Guggenheim conference will be available at www.acadia.com at 9:35 a.m. Eastern Time.
Acadia focuses on neuroscience breakthroughs, including therapies for Parkinson’s disease psychosis and negative symptoms of schizophrenia.
Acadia Pharmaceuticals (Nasdaq: ACAD) reported third-quarter 2022 net sales of $130.7 million for NUPLAZID, representing a 1% decline year-over-year, though driven by 2% sequential demand growth. A Prescription Drug User Fee Act action date is set for March 12, 2023 for trofinetide, aimed at treating Rett syndrome, with the FDA granting priority review. R&D expenses rose to $81.3 million, influenced by milestone payments. Net loss for the quarter expanded to $27.2 million, attributed to increased R&D and compensation expenses. Cash reserves stood at $436.6 million as of September 30, 2022.
Acadia Pharmaceuticals (NASDAQ: ACAD) announced that Dr. Srdjan Stankovic will retire as President at year-end but will continue as an advisor. Dr. Stankovic has been pivotal in advancing Acadia, particularly with the approval of NUPLAZID for Parkinson’s disease psychosis and ongoing drug applications for Rett syndrome and schizophrenia. CEO Steve Davis praised his contributions and the company's exciting R&D portfolio. Acadia remains focused on developing solutions for unmet medical needs in neuroscience.
Acadia Pharmaceuticals will report its third quarter 2022 financial results on November 2, 2022, after markets close. A conference call and webcast will follow at 4:30 p.m. Eastern Time to discuss the financial results and business operations. Acadia has developed the first approved therapy for hallucinations and delusions related to Parkinson's disease psychosis, with ongoing efforts in treating dementia-related psychosis and symptoms in schizophrenia and Rett syndrome. For further details, visit www.acadia.com.
Acadia Pharmaceuticals (ACAD) has appointed Adora Ndu, Pharm.D., J.D., to its Board of Directors. With over 15 years in regulatory affairs and clinical development, Dr. Ndu brings significant expertise to support Acadia's strategic initiatives, particularly as the company prepares to launch its second commercial product, trofinetide, for Rett syndrome. Her prior leadership roles include Chief Regulatory Affairs Officer at BridgeBio and Group VP at BioMarin Pharmaceutical. Dr. Ndu's background in rare diseases complements the existing board, emphasizing a strong focus on central nervous system disorders.
Acadia Pharmaceuticals has launched the Rett Revealed awareness campaign, featuring a photo mosaic by Rett syndrome patient Emily Shifflet. The campaign encourages community participation by submitting meaningful photos until October. Acadia will also light its headquarters purple for Rett syndrome awareness month and support 15 events organized by the International Rett Syndrome Foundation and Rett Syndrome Research Trust. Rett syndrome affects approximately 6,000 to 9,000 patients in the U.S., and there are currently no FDA-approved treatments.
Acadia Pharmaceuticals Inc. has announced that the FDA has accepted its New Drug Application (NDA) for trofinetide aimed at treating Rett syndrome. The FDA granted a priority review and set a Prescription Drug User Fee Act (PDUFA) action date of March 12, 2023. If approved, trofinetide will be the first medication for Rett syndrome, a rare disorder affecting 1 in 10,000 to 15,000 female births globally. The NDA is backed by a Phase 3 study showing significant symptom improvement in patients aged 5-20, highlighting Acadia's commitment to addressing high unmet needs in neuroscience.
FAQ
What is the current stock price of Acadia Pharmaceuticals (ACAD)?
What is the market cap of Acadia Pharmaceuticals (ACAD)?
