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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 (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.
Acadia Pharmaceuticals (Nasdaq: ACAD) announced its participation in the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 10:30 a.m. Eastern Time. The event will be held virtually, featuring a live audio-only webcast of Acadia's presentation and Q&A session, which can be accessed on their website and will be available for replay until February 11, 2022.
Acadia focuses on advancing neuroscience breakthroughs, including treatments for psychosis related to Parkinson's disease, dementia, schizophrenia, and Rett syndrome.
Acadia Pharmaceuticals has announced plans to resubmit its supplemental New Drug Application (sNDA) for pimavanserin, aimed at treating hallucinations and delusions associated with Alzheimer's disease psychosis, in the first quarter of 2022. The resubmission will include new analyses from two positive Phase 3 studies, ultimately supporting its clinical benefits without worsening cognitive or motor functions in elderly patients. The company has had constructive discussions with the FDA regarding the resubmission process.
Acadia Pharmaceuticals Inc. has promoted Mark Schneyer to Executive Vice President and Chief Financial Officer (CFO), effective immediately. Schneyer, who served as interim CFO since September 2021, will oversee finance, accounting, investor relations, and business development. CEO Steve Davis expressed confidence in Schneyer’s leadership and experience, highlighting his role in strategic growth initiatives and the acquisition of CerSci Therapeutics. Schneyer joined Acadia in 2020 from Pfizer, bringing extensive experience in corporate finance and strategic transactions.
Acadia Pharmaceuticals announced positive results from its pivotal Phase 3 Lavender study of trofinetide for treating Rett syndrome in 187 girls and young women aged 5-20. The study met co-primary endpoints, showing statistically significant improvements in the Rett Syndrome Behaviour Questionnaire (p=0.0175) and Clinical Global Impression of Improvement (p=0.0030). Additionally, trofinetide improved a key secondary endpoint related to communication (p=0.0064). A pre-NDA meeting with the FDA is planned for Q1 2022, with an NDA submission expected mid-year.
Acadia Pharmaceuticals (ACAD) announced the publication of Phase 2 ADVANCE study results in The Lancet Psychiatry, which evaluated pimavanserin as an adjunctive treatment for schizophrenia's negative symptoms. The study demonstrated a significant improvement in negative symptoms from baseline to week 26 compared to placebo (-10.4 vs. -8.5; p=0.043). Pimavanserin was well-tolerated, with completion rates around 86%, and similar adverse event rates between groups. Acadia plans to continue evaluating pimavanserin in its Phase 3 ADVANCE-2 study.
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