UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
Acadia Pharmaceuticals Inc. (the “Company”) announced on December 20, 2021 that it plans to resubmit its supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia focused on Alzheimer’s disease psychosis (ADP). Resubmission of the sNDA to the U.S. Food and Drug Administration (FDA) is planned for the first quarter of 2022. The resubmission is intended to demonstrate pimavanserin’s clinically meaningful benefit in ADP patients, without worsening of cognition or motor function in this elderly population. The resubmission will include data from two positive, placebo-controlled studies that prospectively met their primary endpoints: the pivotal Phase 3 HARMONY study and the -019 study. Additional analyses from HARMONY and -019 will also be provided that validate the primary conclusions from each study and address the concerns raised in the FDA’s complete response letter.
A copy of ACADIA’s press release issued December 20, 2021 is furnished herewith as Exhibit 99.1. A copy of the presentation for the related conference call is furnished herewith as Exhibit 99.2.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 |
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| 99.2 | Regulatory Update on sNDA for Pimavanserin | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Acadia Pharmaceuticals Inc. | ||||||||
| Dated: December 20, 2021 | By: | /s/ Austin D. Kim |
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| Austin D. Kim | ||||||||
| Executive Vice President, General Counsel & Secretary | ||||||||