Acadia Pharma call on regulatory update on dementia-psychosis med

 - Conference call and webcast to be held today at 5:00 p.m. Eastern Time

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Company received a notification from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company’s supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

The notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. The Company plans to work with the FDA to learn the nature of the deficiencies and seek to resolve them. In July 2020, the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2021 for completion of its review of the sNDA.

Conference Call and Webcast Information

Acadia management will discuss today’s announcement via conference call and webcast at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4153316). A telephone replay of the conference call may be accessed through March 15, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4153316). The conference call also will be webcast live on Acadia’s website, www.acadia-pharm.com under the investors section and will be archived there through April 8, 2021.

https://finance.yahoo.com/news/acadia-pharmaceuticals-provides-regulatory-supplemental-210500999.html