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 (NASDAQ: ACAD) generates news flow typical of a commercial-stage biopharmaceutical company focused on central nervous system disorders. As a CNS-focused biotech, Acadia's announcements span FDA regulatory decisions, clinical trial results, quarterly earnings reports, and pipeline development updates.
Clinical trial readouts represent significant news events for Acadia, as Phase 2 and Phase 3 study results determine whether drug candidates advance toward potential approval. COMPASS and LOTUS studies exemplify the types of clinical programs that generate data presentations at medical conferences and subsequent news coverage analyzing implications for the company's pipeline.
FDA interactions produce material announcements including new drug application submissions, complete response letters, and approval decisions. For a company concentrated in CNS therapeutics, regulatory milestones carry particular weight given the complexity of developing treatments for neurological and psychiatric conditions.
Quarterly earnings reports reveal commercial product performance, pipeline investment levels, and cash position updates. As Acadia balances commercial revenue against research and development spending, earnings calls provide insight into the sustainability of this business model and management's capital allocation priorities.
Executive appointments and governance changes reflect Acadia's organizational development as it expands commercial and clinical capabilities. R&D Day events and investor presentations offer deeper visibility into scientific strategy and long-term pipeline direction.
Bookmark this page to follow Acadia's clinical development progress, regulatory interactions, and commercial performance in the CNS therapeutics space.
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.
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.
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