# EDGAR Filing Document

**Accession Number:** 0001347178
**File Stem:** 0001628280-25-043489
**Filing Date:** 2025-10
**Character Count:** 11265
**Document Hash:** a156b57df3e43c9589e7f6878265440f
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001628280-25-043489.hdr.sgml**: 20251001

**ACCESSION NUMBER**: 0001628280-25-043489

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251001

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251001

**DATE AS OF CHANGE**: 20251001

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Vanda Pharmaceuticals Inc.
- **CENTRAL INDEX KEY:** 0001347178
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 030491827
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-34186
- **FILM NUMBER:** 251365484

**BUSINESS ADDRESS:**
- **STREET 1:** 2200 PENNSYLVANIA AVE NW
- **STREET 2:** SUITE 300E
- **CITY:** WASHINGTON
- **STATE:** DC
- **ZIP:** 20037
- **BUSINESS PHONE:** 202-734-3400

**MAIL ADDRESS:**
- **STREET 1:** 2200 PENNSYLVANIA AVE NW
- **STREET 2:** SUITE 300E
- **CITY:** WASHINGTON
- **STATE:** DC
- **ZIP:** 20037

?xml version='1.0' encoding='ASCII'? vnda-20251001

**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): October 1, 2025** 

**VANDA PHARMACEUTICALS INC.**

**(Exact name of Registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| **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:

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| | | |
|:---|:---|:---|
| **<u>Title of each class</u>** | **<u>Trading Symbol(s)</u>** | **<u>Name of each exchange on which registered</u>** |
| **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. ◻

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| | |
|:---|:---|
| **Item 8.01.** | **Other Events.** |

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On October 1, 2025, Vanda Pharmaceuticals Inc. ("Vanda") issued a press release announcing that it had reached a collaborative framework with the U.S. Food and Drug Administration for the resolution of certain disputes regarding Vanda's drugs, HETLIOZ<sup>®</sup> (tasimelteon) and tradipitant.

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

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| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.** |

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&nbsp;&nbsp;&nbsp;&nbsp;(d)Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | <u>[Press release of Vanda Pharmaceuticals Inc. dated October 1, 2025.](vnda8-k1012025exhibit991.htm)</u> |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

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**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: | October 1, 2025 | VANDA PHARMACEUTICALS INC. | VANDA PHARMACEUTICALS INC. |
|  |  | By: | /s/ Timothy Williams |
|  |  | Name: | Timothy Williams |
|  |  | Title: | Senior Vice President, General Counsel and Secretary |

---

## Exhibit 99.1

**Exhibit 99.1**

![vandaq32019earningsca_imaga.jpg](vandaq32019earningsca_imaga.jpg)

**Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration**

WASHINGTON, Oct. 1, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has agreed on a collaborative framework with the U.S. Food and Drug Administration (FDA) for the resolution of certain disputes regarding HETLIOZ<sup>®</sup> (tasimelteon) and tradipitant.

Key features of the agreement include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The FDA will conduct an expedited re-review of the partial clinical hold preventing long term clinical studies of tradipitant for the treatment of motion sickness by November 26, 2025. The FDA will continue its review of Vanda's New Drug Application (NDA) for this indication, with the existing Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The FDA will conduct an expedited re-review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ<sup>®</sup> for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder. During the re-review, Vanda and the FDA will seek a temporary pause of the Part 12 proceedings that result from the D.C. Circuit's recent decision in *Vanda Pharmaceuticals v. FDA*, No. 24-1049 (D.C. Cir.).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The FDA and Vanda will seek a temporary pause of the ongoing administrative proceedings before the FDA Commissioner for Vanda's NDA for tradipitant for the treatment of gastroparesis, until January 7, 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Vanda and the FDA have sought a pause in Vanda's lawsuit challenging the FDA's practice of taking up to 12 months—rather than the statutory 180 days—to decide new drug applications, *Vanda Pharms. Inc. v. FDA*, Nos. 24-cv-351 and 25-cv-536 (D.D.C.).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Vanda will dismiss its lawsuit challenging the FDA's partial clinical hold preventing long term studies of tradipitant for the treatment of motion sickness, *Linn v. FDA*, No. 2:25-cv-32 (M.D. Fla.).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Vanda will dismiss its lawsuit regarding Vanda's request to provide information to prescribers and patients regarding the efficacy of HETLIOZ<sup>®</sup> in jet lag disorder, *Vanda Pharms. Inc. v. FDA*, No. 4:25-cv-1648 (S.D. Tex.).

**About Vanda Pharmaceuticals Inc.**

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.

**CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS**

Various statements in this press release, including, but not limited to statements regarding the actions that the FDA is expected to take, and the timing thereof, with respect to the NDA for tradipitant for the treatment of motion sickness and the sNDA for HETLIOZ<sup>®</sup> for the treatment of jet lag disorder, and the actions that Vanda and the FDA are expected to take with respect to certain of their ongoing administrative proceedings and litigation, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to conduct expedited re-reviews of the partial clinical hold on tradipitant for the treatment of motion sickness by November 26, 2025 and the sNDA for HETLIOZ<sup>®</sup> for the treatment of jet lag disorder by January 7, 2026, the FDA's ability to complete its review of the NDA for tradipitant for the treatment of motion sickness by the existing PDUFA target action date of December 30, 2025, and the results of the FDA's review of the NDA for tradipitant for the treatment of gastroparesis. Therefore, no assurance can be given that the results or developments anticipated

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by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

**<u>Corporate Contact:</u>**

Kevin Moran

Senior Vice President, Chief Financial Officer and Treasurer

Vanda Pharmaceuticals Inc.

202-734-3400

pr@vandapharma.com

Jim Golden / Jack Kelleher / Dan Moore

Collected Strategies

VANDA-CS@collectedstrategies.com

SOURCE Vanda Pharmaceuticals Inc.

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