ACADIA PHARMACEUTICALS INC false 0001070494 0001070494 2021-04-05 2021-04-05

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 5, 2021

Acadia Pharmaceuticals Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware |  | 000-50768 |  | 06-1376651
(State or Other Jurisdiction of Incorporation) |  | (Commission File Number) |  | (IRS Employer Identification No.)

12830 El Camino Real, Suite 400 San Diego, California |  | 92130
(Address of Principal Executive Offices) |  | (Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 558-2871

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. of Form 8-K):

☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities | registered pursuant to Section 12(b) of the Act:

Title of each class |  | Trading Symbol(s) |  | Name of each exchange on which registered
Common Stock, par value $0.0001 per share |  | ACAD |  | The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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).

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: April 5, 2021 |  |  |  | By: |  | /s/ Austin D. Kim
|  |  |  |  |  | Austin D. Kim
|  |  |  |  |  | Executive Vice President, General Counsel & Secretary