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 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 announced a virtual FDA meeting for the review of the supplemental New Drug Application (sNDA) for pimavanserin, aimed at treating hallucinations and delusions in Alzheimer’s disease psychosis. The meeting is set for June 17, 2022, with a target action date of August 4, 2022. CEO Steve Davis emphasized the urgency given the lack of FDA-approved treatments for this condition, which affects around 30% of the 6 million Alzheimer’s patients in the U.S. Pimavanserin is currently approved for Parkinson’s disease psychosis.
Acadia Pharmaceuticals (NASDAQ: ACAD) will announce its first quarter 2022 financial results on May 4, 2022, after U.S. market close. A conference call and webcast will follow at 4:30 p.m. Eastern Time, allowing participants to discuss the financial results and operations. Interested parties can access the call via phone or through Acadia’s website. Acadia focuses on neuroscience advancements, including treatments for Parkinson’s disease psychosis and dementia-related psychosis, along with other central nervous system disorders.
Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) announced top-line results from a Phase 2 clinical trial for ACP-044, intended for acute pain relief post-bunionectomy. The trial's primary endpoint was unmet, showing no statistically significant pain reduction with either ACP-044 regimen versus placebo. However, the 400 mg dose exhibited a numerical trend favoring lower pain scores. No serious adverse events were reported, and ongoing studies for chronic pain management are in progress.
Acadia Pharmaceuticals announced a late-breaking oral presentation at the 2022 American Academy of Neurology Annual Meeting in Seattle, WA, highlighting data from the Phase 3 Lavender trial of trofinetide for Rett syndrome. Scheduled for April 5, this pivotal study aims to address the significant unmet needs of patients. Additionally, an e-poster will review the efficacy of pimavanserin in managing psychosis in Parkinson’s disease. Rett syndrome affects approximately 6,000-9,000 patients in the US, underscoring the importance of these findings.
Acadia Pharmaceuticals, listed on NASDAQ as ACAD, will present at the 1st Annual Needham Virtual Neuroscience Forum on March 16, 2022, at 3:20 p.m. ET. A live webcast of the presentation can be accessed through the company’s website, with an archived version available until April 16, 2022.
Acadia is focused on neuroscience advancements, being known for its therapy for hallucinations in Parkinson’s disease psychosis. The company is also developing treatments for dementia-related psychosis and other neuropsychiatric conditions.
Acadia Pharmaceuticals (NASDAQ: ACAD) announced that the FDA has set a target action date of August 4, 2022 for its resubmitted supplemental New Drug Application for pimavanserin, aimed at treating hallucinations and delusions associated with Alzheimer’s disease psychosis. An FDA Advisory Committee meeting is also planned as part of the review process. With around 30% of Alzheimer's patients experiencing psychosis, the approval could address a critical unmet need in this area, enhancing the lives of patients and caregivers.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) will present at the Cowen 42nd Annual Health Care Conference on March 9, 2022, at 2:50 p.m. Eastern Time. The conference is virtual, and a live webcast will be available on Acadia’s website, with an archived recording accessible until April 9, 2022.
Acadia focuses on breakthroughs in neuroscience, notably developing the first approved therapy for hallucinations and delusions related to Parkinson’s disease psychosis and is targeting psychosis in dementia, schizophrenia, and Rett syndrome.
Acadia Pharmaceuticals (ACAD) reported a 10% increase in full-year 2021 net sales, totaling $484.1 million, driven by strong NUPLAZID prescription growth. The company has resubmitted its sNDA for pimavanserin targeting Alzheimer's disease psychosis and announced positive results from the Phase 3 Lavender trial for trofinetide in Rett syndrome. Despite a net loss of $167.9 million for 2021, improved cash reserves stand at $520.7 million. Acadia's 2022 guidance includes projected NUPLAZID sales of $510 to $560 million.
Acadia Pharmaceuticals (NASDAQ: ACAD) has resubmitted its supplemental New Drug Application (sNDA) for pimavanserin to the FDA, addressing the issues raised in a Complete Response Letter received in April 2021. The sNDA is aimed at gaining approval for pimavanserin to treat hallucinations and delusions associated with Alzheimer's disease psychosis (ADP). The resubmission includes new analyses from the HARMONY and Study-019 clinical trials, which support the proposed indication. Currently, no FDA-approved treatment exists for ADP.
Acadia Pharmaceuticals will report its fourth quarter and full year 2021 financial results on February 28, 2022, after U.S. market close. A conference call to discuss these results is scheduled for 4:30 p.m. Eastern Time on the same day. Participants can access the call via phone or through a live webcast on Acadia's website, where the session will be archived until March 28, 2022. The company has a strong focus on neuroscience and has developed treatments for Parkinson’s disease psychosis and is working on therapies for dementia-related psychosis and schizophrenia.