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.
News and updates for Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) focus on its activities in neurological and rare diseases, including commercial performance and clinical development. Company press releases highlight revenue trends from its marketed medicines NUPLAZID for hallucinations and delusions associated with Parkinson’s disease psychosis and DAYBUE for Rett syndrome, as well as guidance ranges for total revenues and net product sales.
Investors following ACAD news can see announcements of quarterly financial results, participation in major healthcare and investor conferences, and business updates presented at events such as the J.P. Morgan Healthcare Conference. These updates often describe how NUPLAZID and DAYBUE are performing commercially and how Acadia views the growth outlook for its neurology and neuro‑rare franchises.
Acadia’s news flow also covers regulatory and clinical milestones. Examples include U.S. Food and Drug Administration approval of DAYBUE STIX, a powder formulation of trofinetide for oral solution for Rett syndrome in adults and pediatric patients 2 years of age and older, approval of DAYBUE oral solution by the Ministry of Health in Israel, and progress toward regulatory opinions and late‑stage studies for trofinetide in other regions. The company issues updates on its pipeline, such as timelines for Phase 2 and Phase 3 trials of remlifanserin (ACP‑204) in Alzheimer’s disease psychosis and Lewy body dementia psychosis, and data presentations on ACP‑711 and NUPLAZID at scientific congresses.
Readers of this ACAD news page can use it to track Acadia’s financial disclosures, regulatory approvals, clinical trial readouts, and strategic commentary from management over time. The news archive provides context on how the company’s commercial portfolio and pipeline in central nervous system and neuro‑rare diseases are evolving.
Acadia Pharmaceuticals (Nasdaq: ACAD) will release its second quarter 2021 financial results on August 4, 2021, after market close. A conference call is scheduled for the same day at 4:30 p.m. Eastern Time to discuss these results. Participants can access the call via dial-in numbers or through a live webcast available on Acadia's website. The company continues to focus on neuroscience breakthroughs, particularly in developing therapies for conditions such as dementia-related psychosis and schizophrenia, while also noting the risks associated with drug development.
Acadia Pharmaceuticals (Nasdaq: ACAD) announced three scientific presentations on dementia-related psychosis at the Alzheimer’s Association International Conference 2021, occurring July 26-30 in Denver and virtually.
The presentations include two studies on pimavanserin used alongside antidementia medications, focusing on safety outcomes and pharmacokinetic profiles. A third study will introduce a novel screening tool for psychosis in dementia.
These findings aim to enhance understanding and treatment strategies for patients with neurodegenerative conditions.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) has published new data from an open-label extension study regarding the efficacy of NUPLAZID for treating hallucinations and delusions in patients with Parkinson’s disease psychosis (PDP). The study revealed sustained efficacy for patients previously on a 34 mg dose of NUPLAZID from Weeks 6 to 10. Approximately 50% of Parkinson’s patients may experience these troubling symptoms, which can significantly impact quality of life. The findings reinforce NUPLAZID's position as a critical first-line therapy for PDP.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced the publication of open-label extension (OLE) data showing sustained efficacy of NUPLAZID (34 mg) for treating hallucinations and delusions in Parkinson's disease psychosis (PDP). Patients previously on lower doses demonstrated improvement after switching to NUPLAZID. The OLE study involved 459 patients, of which 424 were assessed, revealing significant symptom improvements. Adverse events were reported by 46.8% of patients, mostly mild, with some serious cases. This data reinforces NUPLAZID's role as a first-line therapy for PDP.
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.
FAQ
What is the current stock price of Acadia Pharmaceuticals (ACAD)?
What is the market cap of Acadia Pharmaceuticals (ACAD)?
