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 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.