[8-K] Vanda Pharmaceuticals Inc. Reports Material Event

Q: Which Sanofi drug received EU approval in July 2025?

Sarclisa (isatuximab) was approved for transplant-eligible, newly diagnosed multiple myeloma.

Q: What regulatory benefit did SAR446523 obtain in the United States?

The FDA granted Orphan Drug Designation , potentially giving the therapy seven years of market exclusivity upon approval.

[8-K] Vanda Pharmaceuticals Inc. Reports Material Event

Filing Impact

(Neutral)

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(Neutral)

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8-K

Rhea-AI Filing Summary

Sanofi鈥檚 Form 6-K simply furnishes two July 2025 press releases that highlight regulatory milestones in multiple myeloma.

25 Jul 2025 鈥� Sarclisa EU approval: The European Commission authorized Sarclisa (isatuximab) for use in transplant-eligible, newly diagnosed multiple myeloma, broadening the drug鈥檚 label beyond relapsed/refractory settings.
30 Jul 2025 鈥� FDA orphan designation: The FDA granted Orphan Drug Designation to SAR446523, a monoclonal antibody targeting GPRC5D, for multiple myeloma.

No financial data, guidance or transactional details accompanied the disclosures. Nonetheless, both actions strengthen Sanofi鈥檚 hematology-oncology franchise and could expand its addressable patient population once commercialized.

Insights

TL;DR 鈥� Two regulatory wins enhance Sanofi鈥檚 multiple-myeloma pipeline; long-term revenue optionality rises.

The EU approval of Sarclisa in front-line, transplant-eligible MM extends the drug鈥檚 commercial reach into an earlier-stage setting, typically the largest market segment. Although immediate sales impact is undisclosed, label expansion often drives meaningful uptake over time. Separately, FDA orphan designation for SAR446523 confers seven-year US exclusivity if approved and access to development incentives, lowering clinical and economic risk. While the 6-K lacks financials, the dual milestones collectively improve pipeline value and diversify future hematology revenues.

TL;DR 鈥� Milestones validate Sanofi鈥檚 strategy of targeting multiple antigens in MM.

Sarclisa now competes earlier against Darzalex, positioning Sanofi to capture share in newly diagnosed, transplant-eligible patients. The GPRC5D antibody taps an emerging target distinct from CD38, enabling combination or sequential therapy. Orphan status eases the regulatory path and underscores clinical need. Overall, these steps reinforce Sanofi鈥檚 credibility in hematologic oncology and could create durable franchise revenues once SAR446523 progresses.

07/31/2025 - 07:34 AM

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): July 31, 2025

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 2.02.						Results of Operations and Financial Condition.

On July 31, 2025, Vanda Pharmaceuticals Inc. (“Vanda”) issued a press release and is holding a conference call regarding its results of operations and financial condition for the quarter ended June 30, 2025 (the “Earnings Call”). The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Various statements to be made during the Earnings Call are “forward-looking statements” under the securities laws, including, but not limited to, statements regarding Vanda’s commercial products, plans and opportunities, as well as statements about Vanda’s products in development and the related clinical development and regulatory timelines and commercial potential for such products. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “project,” “target,” “goal,” “likely,” “will,” “would,” and “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. 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, Vanda’s assumptions regarding the strength of its business in the U.S. and Vanda’s ability to complete the clinical development of, and obtain regulatory approval for, the products in its pipeline. Therefore, no assurance can be given that the actual 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 made during the Earnings Call 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. The information contained in this Current Report on Form 8-K is intended to be considered in the context of Vanda’s filings with the SEC and other public announcements that Vanda makes, by press release or otherwise, from time to time. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information conveyed on the Earnings Call will be provided only as of the date thereof, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements made during the Earnings Call after the date thereof, whether as a result of new information, future events or otherwise, except as required by law.

The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.


Item 9.01.						Financial Statements and Exhibits.

(d)Exhibits


Exhibit No.						Description

99.1						Press release of Vanda Pharmaceuticals Inc. dated July 31, 2025.

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:

July 31, 2025

VANDA PHARMACEUTICALS INC.

By:

/s/ Timothy Williams

Name:

Timothy Williams

Title:

Senior Vice President, General Counsel and Secretary

Source:

FAQ

What did Sanofi (SNY) disclose in its July 2025 Form 6-K?

The filing furnishes two press releases covering EU approval of Sarclisa and FDA orphan designation for SAR446523.

Which Sanofi drug received EU approval in July 2025?

Sarclisa (isatuximab) was approved for transplant-eligible, newly diagnosed multiple myeloma.

What regulatory benefit did SAR446523 obtain in the United States?

The FDA granted Orphan Drug Designation, potentially giving the therapy seven years of market exclusivity upon approval.

Does the 6-K include financial results or guidance?

No. The document only attaches regulatory press releases and contains no financial figures or outlook.

How could these milestones impact Sanofi鈥檚 oncology portfolio?

They expand Sarclisa鈥檚 market reach and advance a novel GPRC5D antibody, strengthening Sanofi鈥檚 multiple-myeloma franchise.

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[8-K] Vanda Pharmaceuticals Inc. Reports Material Event

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FAQ

What did Sanofi (SNY) disclose in its July 2025 Form 6-K?

Which Sanofi drug received EU approval in July 2025?

What regulatory benefit did SAR446523 obtain in the United States?

Does the 6-K include financial results or guidance?

How could these milestones impact Sanofi鈥檚 oncology portfolio?

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[8-K] Vanda Pharmaceuticals Inc. Reports Material Event

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FAQ

What did Sanofi (SNY) disclose in its July 2025 Form 6-K?

Which Sanofi drug received EU approval in July 2025?

What regulatory benefit did SAR446523 obtain in the United States?

Does the 6-K include financial results or guidance?

How could these milestones impact Sanofi鈥檚 oncology portfolio?

NASDAQ:VNDA

VNDA Rankings

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