Acadia Pharmaceuticals Inc. - ACAD STOCK NEWS

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.

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.