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Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) is a biopharmaceutical company headquartered in San Diego, California, dedicated to the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders. Established with a commitment to scientific excellence and leadership in CNS research, Acadia's proprietary drug discovery platform has enabled the creation of a robust portfolio targeting conditions such as Parkinson's disease psychosis, Alzheimer's disease psychosis, Rett syndrome, and schizophrenia.
Acadia's pivotal achievements include the development and commercialization of NUPLAZID, the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis, and DAYBUE, the first and only FDA-approved drug for the treatment of Rett syndrome. The company's clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.
Situated in San Diego, one of the largest biotechnology hubs in the United States, Acadia benefits from proximity to over 400 companies and renowned research institutions like the Salk Institute for Biological Studies. This strategic location supports Acadia's mission to bring groundbreaking therapies to patients in need.
Financially, Acadia has shown significant growth, with total revenues reaching $205.8 million for the first quarter of 2024, reflecting a 74% year-over-year increase, largely due to the strong market performance of NUPLAZID and the addition of DAYBUE. The company continues to invest in its pipeline and commercial operations, maintaining a solid cash position with $470.5 million in cash, cash equivalents, and investment securities as of March 31, 2024.
Recent highlights include participation in major healthcare conferences, strategic appointments to enhance leadership in research and development, and ongoing efforts to expand the reach of DAYBUE beyond the U.S. market. Acadia’s unwavering dedication to advancing neuroscience and improving patient outcomes underscores its long-term growth potential and commitment to innovation in the biopharmaceutical landscape.
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.
Acadia Pharmaceuticals (NASDAQ: ACAD) will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, at 1:40 p.m. ET. The event will be held virtually, with a live webcast available on Acadia's website under the investors section. An archived recording will be accessible until March 18, 2022. Acadia focuses on neuroscience breakthroughs, having developed the first approved treatment for Parkinson’s disease psychosis and is advancing therapies for dementia-related psychosis and other CNS disorders.
Acadia Pharmaceuticals and Stoke Therapeutics have formed a collaboration to co-develop RNA-based therapies for severe neurodevelopmental diseases, including SYNGAP1 syndrome and Rett syndrome. Acadia gains exclusive licenses for two additional preclinical programs. Stoke receives a $60 million upfront payment, with potential milestone payments reaching $907 million, along with royalties. The partnership combines Stoke’s TANGO research platform with Acadia’s development expertise, aiming to enhance treatment options for patients with these debilitating conditions.
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