Item 7.01 Regulation FD Disclosure.

On April 5, 2021, Acadia Pharmaceuticals Inc. (the "Company") issued a press release announcing the receipt of a complete response letter from the U.S. Food and Drug Administration (the "FDA") regarding the Company's supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis and held a conference call. A copy of the Company's press release dated April 5, 2021 is attached as Exhibit 99.1 and is incorporated herein by reference. A copy of the material presented during the Company's conference call is attached as Exhibit 99.2 and is incorporated herein by reference. The information in this Item 7.01 and Exhibits 99.1 and 99.2 is being furnished to the Securities and Exchange Commission (the "Commission") and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing.




Item 8.01 Other Events.

On April 5, 2021, the Company issued a press release announcing the receipt of a complete response letter from the FDA regarding the Company's supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis and held a conference call. A copy of the Company's press release dated April 5, 2021 is attached as Exhibit 99.1 and is incorporated herein by reference. A copy of the material presented during the Company's conference call is attached as Exhibit 99.2 and is incorporated herein by reference. The information in this Item 8.01 and Exhibits 99.1 and 99.2 is being furnished to the Commission and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.




(d) Exhibits.



Exhibit
Number       Description

99.1           Press Release dated April 5, 2021

99.2           Regulatory Update on DRP sNDA dated April 5, 2021

104          Cover Page Interactive Data File (embedded within the Inline XBRL
             document).

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses