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. (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 reported 2Q22 net sales of $134.6 million, reflecting a 17% increase from 2Q21. The company submitted a New Drug Application (NDA) for trofinetide, aiming to be the first FDA-approved treatment for Rett syndrome. It expects revised net sales guidance for NUPLAZID between $510 to $540 million, amended from $510 to $560 million. R&D expenses rose to $75.6 million due to increased development activities. Acadia reported a net loss of $34.0 million for the quarter, with cash reserves at $436.4 million.
Acadia Pharmaceuticals announced it received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for NUPLAZID (pimavanserin) aimed at treating Alzheimer’s disease-related hallucinations and delusions. The FDA stated that while the application showed promise, it requires further trials due to limitations in the interpretability of Study 019 results. The CRL pointed out that observed benefits might be primarily linked to Parkinson's disease dementia patients, rather than Alzheimer's, highlighting the ongoing unmet need in this treatment area.
Acadia Pharmaceuticals (NASDAQ: ACAD) will report its second quarter 2022 financial results on August 8, 2022, after U.S. market close. A conference call and webcast will follow at 4:30 p.m. Eastern Time to discuss these results. This meeting also aims to provide insights into ongoing operations and strategies. As a leader in neuroscience, Acadia focuses on innovative solutions, including therapies for Parkinson's disease psychosis and dementia-related psychosis. For more details visit www.acadia.com.
Acadia Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for trofinetide, aimed at treating Rett syndrome in patients aged two and older. This submission is based on successful results from the pivotal Phase 3 Lavender study, which showed significant improvement in key measures. Trofinetide has received Fast Track Status and Orphan Drug Designation, and if approved, will potentially qualify for a Priority Review Voucher. Currently, there are no FDA-approved treatments for Rett syndrome, affecting 6,000 to 9,000 patients in the U.S.
Acadia Pharmaceuticals (NASDAQ: ACAD) announced that the FDA Psychopharmacologic Drugs Advisory Committee voted 9 to 3 against the efficacy of pimavanserin for treating hallucinations and delusions in Alzheimer’s disease psychosis (ADP). CEO Steve Davis expressed disappointment but noted the company's belief in the drug's substantial efficacy based on multiple clinical studies. The FDA, although not bound by the committee's recommendation, will consider the vote as it reviews the full safety and efficacy data, with a target action date set for August 4, 2022.
Acadia Pharmaceuticals (NASDAQ: ACAD) announced that the FDA Advisory Committee will review the supplemental New Drug Application for NUPLAZID (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. The virtual meeting is scheduled for 8:45 a.m. ET today. Nasdaq has temporarily halted the trading of Acadia’s common stock. Notably, there is currently no FDA-approved treatment for Alzheimer’s disease psychosis, affecting approximately 30% of Alzheimer’s patients. The target action date for this application is August 4, 2022.
Acadia Pharmaceuticals reported 1Q22 net sales of $115.5 million, an 8% increase from 1Q21. The company is maintaining its FY22 net sales guidance of $510 million to $560 million. A pivotal FDA Advisory Committee meeting regarding the resubmission of the sNDA for pimavanserin in treating Alzheimer’s disease psychosis is set for June 17, 2022, with a target action date of August 4, 2022. Research and development expenses rose significantly to $128.9 million, primarily due to a $60 million payment to Stoke Therapeutics. The company reported a net loss of $113.1 million.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) will participate in two upcoming investor conferences. The BofA Securities 2022 Healthcare Conference features a fireside chat on May 10, 2022, at 3:20 p.m. PT in Las Vegas, NV. The RBC Capital Markets Global Healthcare Conference will include a fireside chat on May 18, 2022, at 4:05 p.m. ET in New York, NY. Live webcasts can be accessed on the company’s website, with recordings available for a month post-event.
Acadia focuses on neuroscience breakthroughs, notably for Parkinson's disease psychosis and dementia-related psychosis.
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.
FAQ
What is the current stock price of Acadia Pharmaceuticals (ACAD)?
What is the market cap of Acadia Pharmaceuticals (ACAD)?
What does Acadia Pharmaceuticals Inc. specialize in?
Where is Acadia Pharmaceuticals headquartered?
What are some of Acadia's key products?
What recent financial performance did Acadia report?
What are Acadia's current research focuses?
What recent achievements has Acadia Pharmaceuticals announced?
How does Acadia support the Rett syndrome community?
What is the significance of Acadia's location in San Diego?
How has Acadia's product portfolio grown recently?
What is Acadia’s approach to drug discovery?
