# EDGAR Filing Document

**Accession Number:** 0001347178
**File Stem:** 0001628280-25-055393
**Filing Date:** 2025-12
**Character Count:** 10441
**Document Hash:** f5e263b4c24654aeddb456ecee11701c
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001628280-25-055393.hdr.sgml**: 20251204

**ACCESSION NUMBER**: 0001628280-25-055393

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251204

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251204

**DATE AS OF CHANGE**: 20251204

**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:** 251550269

**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-20251204

**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): December 4, 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 December 4, 2025, Vanda Pharmaceuticals Inc. ("Vanda") issued a press release announcing that the U.S. Food and Drug Administration has lifted the partial clinical hold on Vanda's drug, tradipitant, for the treatment of motion sickness.

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 December 4, 2025.](vnda8-k1242025exhibit991.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: | December 4, 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_imag.jpg](vandaq32019earningsca_imag.jpg)

**FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness**

WASHINGTON, Dec. 4, 2025 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on protocol VP-VLY-686-3403, which until today limited the protocol to a maximum of 90 doses of tradipitant.

The lift followed Vanda's formal dispute resolution request and an expedited re-review conducted by CDER leadership under the collaborative framework established between Vanda and the FDA in October 2025.

The FDA agreed with Vanda's position that motion sickness is an acute, self-limiting physiologic response rather than a chronic or chronic-intermittent condition. The Agency therefore concluded that the use of tradipitant in motion sickness represents an acute, event-driven therapy, eliminating the need for an additional six-month dog toxicity study and rendering the partial clinical hold unnecessary.

This decision allows Vanda to extend clinical studies of tradipitant in motion sickness. Separately, the ongoing review of the pending, fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track, with a PDUFA target action date of December 30, 2025, positioning tradipitant as potentially the first new pharmacologic treatment for motion sickness in over 40 years.

"The swift and favorable resolution of this issue highlights the effectiveness of our collaborative framework with the FDA," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "We thank the Agency for its thorough and expedited scientific review and look forward to continued constructive dialogue."

**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.

**About Tradipitant**

Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for a variety of indications, including gastroparesis, motion sickness, and the prevention of nausea and vomiting induced by GLP-1 receptor agonists.

**CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS**

Various statements in this press release, including, but not limited to statements regarding Vanda's further clinical development plans for tradipitant, Vanda's pursuit of FDA approval of tradipitant for the prevention of vomiting induced by motion, the potential commercialization of tradipitant for such indication, and Vanda's future interactions with the FDA 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 complete its review of the NDA for tradipitant for the prevention of vomiting induced by motion by December 30, 2025, the FDA's assessment of the evidence supporting the safety and efficacy of tradipitant for the prevention of vomiting induced by motion, and the ability of the FDA and Vanda to continue to work together collaboratively. Therefore, no assurance can be given that the results or developments anticipated 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

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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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