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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 (Nasdaq: ACAD) announced its participation in two upcoming virtual investor conferences. The Jefferies 2021 Virtual Healthcare Conference will feature a fireside chat on June 2, 2021, at 1:30 p.m. ET, followed by the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021, at 2:10 p.m. ET. Live webcasts of both presentations will be available on Acadia's website, with archived recordings accessible for one month post-event. Acadia is focused on neurological solutions, including therapies for Parkinson's disease psychosis and dementia-related psychosis.
Acadia Pharmaceuticals reported Q1 2021 financial results with net sales of NUPLAZID (pimavanserin) at $106.6 million, an 18% increase year-over-year. The company faces challenges, having received a Complete Response Letter from the FDA regarding its sNDA for dementia-related psychosis. R&D expenses decreased to $57 million, while SG&A expenses rose to $111.7 million. Acadia reiterated NUPLAZID net sales guidance of $510-$550 million but revised R&D and SG&A guidance downwards, reflecting strategic adjustments. The company had a net loss of $66.4 million for the quarter.
Acadia Pharmaceuticals (Nasdaq: ACAD) will participate in two upcoming virtual investor conferences. The BofA Securities 2021 Health Care Conference is on May 12, 2021, at 2:45 p.m. ET, followed by the RBC Capital Markets Global Healthcare Conference on May 18, 2021, at 3:05 p.m. ET. Live webcasts will be available on the company's website, with archived recordings accessible for about a month afterward. Acadia focuses on advancing neuroscience solutions for conditions like Parkinson's disease psychosis and dementia-related psychosis.
Acadia Pharmaceuticals (Nasdaq: ACAD) will release its first quarter 2021 financial results on May 5, 2021, after U.S. market close. A conference call to discuss these results will take place at 5:00 p.m. ET the same day. Participants can join by phone or via a live webcast on Acadia's website, with a replay available until May 19, 2021. Acadia is focused on advancing neuroscience solutions, including treatments for Parkinson's disease psychosis and dementia-related psychosis, and is engaged in late-stage development for several mental health conditions.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) has received a Complete Response Letter (CRL) from the FDA for its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) aimed at treating hallucinations and delusions in dementia-related psychosis (DRP). The FDA cited insufficient statistical significance in certain dementia subgroups and a lack of substantial evidence for effectiveness. Acadia intends to request a Type A meeting with the FDA to discuss the CRL and potential approval pathways. No safety concerns were raised in the CRL.
Acadia Pharmaceuticals announced on March 3, 2021, that it received an FDA notification identifying deficiencies in its supplemental New Drug Application (sNDA) review, inhibiting discussions on labeling and post-marketing requirements. The notification lacks specific details on the deficiencies, and the company aims to clarify these issues with the FDA. The FDA had previously set a PDUFA action date of April 3, 2021, for the sNDA review.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) reported strong financial results for Q4 2020, with net sales of NUPLAZID reaching $121 million, a 23% increase from Q4 2019. For the full year, net product sales grew 30% to $441.8 million. However, the company incurred a net loss of $66.8 million for Q4 and $281.6 million for the year. Acadia anticipates net sales of $510-$550 million for NUPLAZID in 2021 but withheld guidance for dementia-related psychosis revenue. Strategic advances include multiple Phase 3 studies and a new FDA label for NUPLAZID.
Acadia Pharmaceuticals has launched MoreThanMemoryLoss.com, an educational website aimed at assisting caregivers and individuals living with dementia. The site offers resources about dementia-related hallucinations and delusions, a common challenge for about 30% of the 8 million people with dementia in the U.S. The initiative was developed with input from caregivers and advocacy groups, featuring guides and personal stories to encourage discussions between caregivers and healthcare providers. This resource aims to address the distressing symptoms of dementia-related psychosis.
Acadia Pharmaceuticals (Nasdaq: ACAD) will participate in two upcoming investor conferences. The 10th Annual SVB Leerink Global Healthcare Conference features a fireside chat on February 26, 2021, at 10:40 a.m. ET. The Cowen 41st Annual Health Care Conference follows with a presentation on March 1, 2021, at 12:20 p.m. ET. Both events will be held virtually, and live webcasts will be available on Acadia's website, followed by archived recordings for about one month. Acadia specializes in neuroscience breakthroughs for conditions like Parkinson’s disease psychosis.
Acadia Pharmaceuticals (Nasdaq: ACAD) will report its fourth quarter and full year 2020 financial results on February 24, 2021, after market close. A conference call to discuss these results will occur the same day at 4:30 p.m. ET, accessible via phone or webcast. Acadia is known for developing the first approved therapy for hallucinations associated with Parkinson’s disease psychosis and is focused on late-stage development for dementia-related psychosis and other CNS disorders. Future projections may be subject to risks inherent in drug development.
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