FDA declines Vanda (NASDAQ: VNDA) HETLIOZ sNDA for jet lag treatment

Rhea-AI Filing Summary

Vanda Pharmaceuticals reports that the U.S. Food and Drug Administration has declined to approve its supplemental New Drug Application (sNDA) for HETLIOZ to treat jet lag disorder in its current form. This follows a previously agreed collaborative framework under which the FDA conducted an expedited re-review of the application by January 7, 2026.

On that date, Vanda received an FDA letter stating that the sNDA cannot be approved as submitted. Vanda disclosed that it issued a press release on January 8, 2026 discussing the FDA’s conclusion, and that release is furnished as an exhibit to this report.

Positive

• None.

Negative

• FDA concluded HETLIOZ jet lag sNDA cannot be approved in its current form, representing a material setback for this planned indication after an expedited re-review process.

Insights

Biopharma regulatory analyst

FDA refusal to approve Vanda’s HETLIOZ jet lag sNDA is a clear regulatory setback.

The key development is that the FDA, after an expedited re-review agreed under a prior collaborative framework, concluded on January 7, 2026 that Vanda’s sNDA for HETLIOZ in jet lag disorder "cannot be approved in its current form." This means the proposed labeling expansion for jet lag is not moving forward as submitted.

Because the application followed a specific, expedited process with an agreed review date, the negative outcome is more significant than an ordinary delay. The company does not describe next steps here, such as resubmission or additional studies, so future direction for this indication will have to come from later disclosures or interactions with the agency.

Investors focused on HETLIOZ’s potential in jet lag disorder may view this as a material adverse event for that program, as it removes the immediate path to approval that was being re-reviewed under the collaborative framework.

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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

FAQ

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

The FDA informed Vanda on January 7, 2026 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 regarding the HETLIOZ jet lag filing?

Vanda previously announced that it had reached a collaborative framework with the FDA under which the agency agreed to conduct an expedited re-review of the HETLIOZ jet lag sNDA by January 7, 2026.

Which HETLIOZ indication is affected for Vanda (VNDA)?

The decision affects Vanda’s supplemental New Drug Application for HETLIOZ for the treatment of jet lag disorder, which the FDA has now declined to approve in its current form.

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

Yes. Vanda states that on January 8, 2026 it issued a press release regarding the FDA’s conclusion, and that release is attached as Exhibit 99.1 and incorporated by reference.

Does this 8-K describe Vanda (VNDA) next steps after the FDA’s refusal?

The report focuses on disclosing that the FDA found the HETLIOZ jet lag sNDA cannot be approved in its current form and refers readers to the attached press release; it does not detail further plans in this document.

What form did Vanda (VNDA) use to report the HETLIOZ jet lag FDA outcome?

Vanda reported the FDA’s conclusion on a Form 8-K, which is used to disclose significant current events to shareholders and the market.