Acadia Pharmaceuticals Inc Stock Price, News & Analysis

Acadia Pharmaceuticals (ACAD) has appointed Adora Ndu, Pharm.D., J.D., to its Board of Directors. With over 15 years in regulatory affairs and clinical development, Dr. Ndu brings significant expertise to support Acadia's strategic initiatives, particularly as the company prepares to launch its second commercial product, trofinetide, for Rett syndrome. Her prior leadership roles include Chief Regulatory Affairs Officer at BridgeBio and Group VP at BioMarin Pharmaceutical. Dr. Ndu's background in rare diseases complements the existing board, emphasizing a strong focus on central nervous system disorders.

Acadia Pharmaceuticals has launched the Rett Revealed awareness campaign, featuring a photo mosaic by Rett syndrome patient Emily Shifflet. The campaign encourages community participation by submitting meaningful photos until October. Acadia will also light its headquarters purple for Rett syndrome awareness month and support 15 events organized by the International Rett Syndrome Foundation and Rett Syndrome Research Trust. Rett syndrome affects approximately 6,000 to 9,000 patients in the U.S., and there are currently no FDA-approved treatments.

Acadia Pharmaceuticals Inc. has announced that the FDA has accepted its New Drug Application (NDA) for trofinetide aimed at treating Rett syndrome. The FDA granted a priority review and set a Prescription Drug User Fee Act (PDUFA) action date of March 12, 2023. If approved, trofinetide will be the first medication for Rett syndrome, a rare disorder affecting 1 in 10,000 to 15,000 female births globally. The NDA is backed by a Phase 3 study showing significant symptom improvement in patients aged 5-20, highlighting Acadia's commitment to addressing high unmet needs in neuroscience.

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) will participate in several upcoming investor conferences in September 2022. Key events include the Citi’s 17th Annual BioPharma Conference on September 8 at 1:00 p.m. ET in Boston, the Morgan Stanley 20th Annual Global Healthcare Conference on September 13 at 11:10 a.m. ET in New York, and the Cowen 2nd Annual Novel Mechanisms in Neuropsychiatry Virtual Summit on September 19 at 2:10 p.m. ET. Live webcasts will be accessible on Acadia’s website, with recordings available for one month post-event.

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.