Vanda gets FDA refusal on HETLIOZ jet lag sNDA

Rhea-AI Filing Summary

Vanda Pharmaceuticals reports that the U.S. Food and Drug Administration has completed an expedited re-review of its supplemental New Drug Application for HETLIOZ as a treatment for jet lag disorder and concluded the application cannot be approved in its current form. This re-review was conducted under a previously announced collaborative framework between Vanda and the FDA, with a target date of January 7, 2026. The decision represents a setback for Vanda’s efforts to add jet lag disorder as a new indication for HETLIOZ. Vanda issued a press release on January 8, 2026, and has attached the full text as an exhibit.

Positive

• None.

Negative

• FDA concluded Vanda’s HETLIOZ sNDA for jet lag disorder cannot be approved in its current form after expedited re-review.

Insights

Biopharma regulatory analyst

FDA declined to approve Vanda’s HETLIOZ jet lag sNDA after re-review.

Vanda Pharmaceuticals describes an FDA decision that its supplemental New Drug Application for HETLIOZ to treat jet lag disorder "cannot be approved in its current form" following an expedited re-review. This follows an earlier collaborative framework where the FDA agreed to complete that re-review by January 7, 2026, so the decision effectively closes out that process without approval for the proposed indication.

For Vanda, this outcome is a clear regulatory setback for expanding HETLIOZ beyond its existing uses into jet lag disorder. The disclosure notes that the company issued a press release on January 8, 2026, and attached it as an exhibit, which suggests further detail on the company’s response and next steps may be contained there. The actual commercial and pipeline impact will depend on any future regulatory strategy Vanda may pursue, which is not described in this excerpt.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the FDA decide about Vanda (VNDA) HETLIOZ jet lag application?

The FDA informed Vanda that, after an expedited re-review, the supplemental New Drug Application for HETLIOZ to treat jet lag disorder cannot be approved in its current form.

What prior agreement did Vanda (VNDA) have with the FDA on the HETLIOZ sNDA?

Vanda had reached a collaborative framework under which the FDA agreed to conduct an expedited re-review of the HETLIOZ jet lag supplemental New Drug Application by January 7, 2026.

When did Vanda (VNDA) receive the FDA’s HETLIOZ sNDA decision?

Vanda received a letter from the FDA on January 7, 2026 stating that the HETLIOZ jet lag supplemental New Drug Application cannot be approved in its current form.

Did Vanda (VNDA) issue a press release about the FDA’s HETLIOZ decision?

Yes. Vanda issued a press release on January 8, 2026 regarding the FDA’s conclusion, and the full text is attached as Exhibit 99.1.

Which product in Vanda’s pipeline is affected by this 8-K disclosure?

The disclosure relates to HETLIOZ, specifically Vanda’s supplemental New Drug Application seeking approval for the treatment of jet lag disorder.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 01/08/2026 - 07:09 AM Learn about SEC filing dates

0001347178FALSE00013471782026-01-072026-01-07

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): January 7, 2026

VANDA PHARMACEUTICALS INC.

(Exact name of Registrant as specified in its charter)

Delaware

001-34186

03-0491827

(State or other jurisdiction of incorporation)

(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(s)			Name of each exchange on which registered
Common Stock, par value $0.001 per share			VNDA			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.  ¨

Item 8.01. Other Events.

As previously disclosed, on October 1, 2025, Vanda Pharmaceuticals Inc. (“Vanda”) announced that it had reached a collaborative framework with the U.S. Food and Drug Administration (the “FDA”) pursuant to which, among other things, the FDA had agreed to conduct an expedited re-review of Vanda’s supplemental New Drug Application (the “sNDA”) for HETLIOZ® for the treatment of jet lag disorder by January 7, 2026. On January 7, 2026, Vanda received a letter from the FDA stating that, following this re-review, it had concluded that the sNDA cannot be approved in its current form. On January 8, 2026, Vanda issued a press release regarding the FDA’s conclusion.

The full text of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d)Exhibits

Exhibit No.						Description
99.1						Press release of Vanda Pharmaceuticals Inc. dated January 8, 2026.
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.

Dated:

January 8, 2026

VANDA PHARMACEUTICALS INC.

By:

/s/ Timothy Williams

Name:

Timothy Williams

Title:

Senior Vice President, General Counsel and Secretary