Acadia Pharmaceuticals Inc Stock Price, News & Analysis

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.

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) announced top-line results from a Phase 2 clinical trial for ACP-044, intended for acute pain relief post-bunionectomy. The trial's primary endpoint was unmet, showing no statistically significant pain reduction with either ACP-044 regimen versus placebo. However, the 400 mg dose exhibited a numerical trend favoring lower pain scores. No serious adverse events were reported, and ongoing studies for chronic pain management are in progress.

Acadia Pharmaceuticals announced a late-breaking oral presentation at the 2022 American Academy of Neurology Annual Meeting in Seattle, WA, highlighting data from the Phase 3 Lavender trial of trofinetide for Rett syndrome. Scheduled for April 5, this pivotal study aims to address the significant unmet needs of patients. Additionally, an e-poster will review the efficacy of pimavanserin in managing psychosis in Parkinson’s disease. Rett syndrome affects approximately 6,000-9,000 patients in the US, underscoring the importance of these findings.