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): August 19, 2019 (August 16, 2019)
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| | |
001-34186 | | 03-0491827 |
(Commission File No.) | | (IRS Employer Identification No.) |
2200 Pennsylvania Avenue NW
Suite 300E
Washington, DC 20037
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (202) 734-3400
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | 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 | | Name of each exchange on which registered |
Common Stock, par value $0.001 | | VNDA | | The Nasdaq Stock Market LLC (The Nasdaq Global Market) |
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. ☐
On October 16, 2018, Vanda Pharmaceuticals Inc. (the “Company”) submitted to the U.S. Food and Drug Administration (the “FDA”) a supplemental New Drug Application (the “sNDA”) under Section 505(b) of the Federal Food, Drug and Cosmetic Act for HETLIOZ® (tasimelteon) capsule, 20 mg, for the treatment of jet lag disorder. On December 19, 2018, the Company received a letter from the FDA notifying the Company that the FDA assigned a Prescription Drug User Fee Act (“PDUFA”) target date for completion of its review by August 16, 2019.
As previously disclosed, on July 19, 2019, the Company received a letter from the FDA (the “Letter”) stating that, as part of its ongoing review of the sNDA, the FDA had identified deficiencies that precluded the discussion of labeling and postmarketing requirements/commitments at that time. The Letter did not specify the deficiencies identified by the FDA.
On August 16, 2019, the Company received a complete response letter (the “CRL”) from the FDA regarding the sNDA and on August 19, 2016, the Company issued a press release regarding the CRL. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
| Item 9.01. | Financial Statements and Exhibits. |
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.
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Dated: August 19, 2019 | | | | VANDA PHARMACEUTICALS INC. |
| | | | | | | |
| | | | By: | | /s/ Timothy Williams |
| | | | Name: | | Timothy Williams |
| | | | Title: | | Senior Vice President, General Counsel and Secretary |
