Roivant posts positive Phase 3 VALOR results

Roivant Sciences Ltd. reported that its subsidiary Priovant Therapeutics achieved positive results in the Phase 3 VALOR study of brepocitinib in dermatomyositis, a serious autoimmune muscle disease.

Rhea-AI Filing Summary

Roivant Sciences Ltd. reported that its subsidiary Priovant Therapeutics achieved positive results in the Phase 3 VALOR study of brepocitinib in dermatomyositis, a serious autoimmune muscle disease. The company released a detailed press release and an investor presentation describing these Phase 3 results.

Roivant also scheduled a conference call and webcast at 8:00 a.m. E.D.T. on September 17, 2025 to discuss the VALOR data, and posted the related presentation on the investor relations section of its website. These materials are furnished as exhibits to the report, giving investors additional information on the study outcome.

Positive

• Positive Phase 3 VALOR results for brepocitinib in dermatomyositis at Priovant Therapeutics represent a major late-stage clinical milestone for Roivant Sciences.

Negative

• None.

Insights

Biopharmaceutical clinical and regulatory analyst

Positive Phase 3 VALOR results strengthen Roivant's dermatomyositis program.

Roivant Sciences, via its subsidiary Priovant Therapeutics, reported positive Phase 3 VALOR data for brepocitinib in dermatomyositis. A successful Phase 3 trial is a key late-stage milestone in drug development and can support future regulatory interactions, depending on detailed efficacy and safety outcomes described in the press release and presentation.

The company supplemented the news with a press release and an investor presentation, and organized a conference call on September 17, 2025 at 8:00 a.m. E.D.T. to discuss the results. The actual impact for Roivant will depend on the strength of the VALOR dataset, how regulators view the totality of evidence, and any additional disclosures the company makes in subsequent filings or communications.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

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 Roivant Sciences (ROIV) announce in this 8-K filing?

Roivant Sciences announced that its subsidiary Priovant Therapeutics reported positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis.

Which drug and indication are involved in Roivant Sciences' Phase 3 VALOR study?

The Phase 3 VALOR study evaluated brepocitinib in patients with dermatomyositis, an autoimmune disease affecting muscles and skin.

Where can investors find more details on Roivant Sciences' VALOR Phase 3 results?

Details are provided in a press release filed as Exhibit 99.1 and an investor presentation filed as Exhibit 99.2, with the presentation also posted on Roivant’s investor relations website.

Did Roivant Sciences host a call to discuss the VALOR Phase 3 results?

Yes. Roivant scheduled a conference call and webcast to discuss the VALOR Phase 3 results at 8:00 a.m. E.D.T. on September 17, 2025.

Are the VALOR results and exhibits considered filed for liability purposes?

No. The information under Item 7.01, including Exhibits 99.1 and 99.2, is furnished, not filed, and is not subject to liability under Section 18 of the Exchange Act or Sections 11 and 12(a)(2) of the Securities Act.

Is Roivant Sciences incorporating the VALOR presentation into its other SEC filings?

The company states that the information in Item 7.01 and Exhibits 99.1 and 99.2 shall not be deemed incorporated by reference into any other SEC filing.

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Accepted by SEC EDGAR 09/17/2025 - 07:45 AM Learn about SEC filing dates

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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): September 17, 2025

Roivant Sciences Ltd.

(Exact name of registrant as specified in its charter)

Bermuda	001-40782	98-1173944
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

7th Floor

50 Broadway

London SW1H 0DB

United Kingdom

(Address of principal executive offices, and Zip Code)

+44 207 400-3347

Registrant’s Telephone Number, Including Area Code

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 Shares, $0.0000000341740141 per share		ROIV		The Nasdaq Global Select 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 7.01 Regulation FD Disclosure.

On September 17, 2025, Roivant Sciences Ltd. (the “Company”) issued a press release announcing positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis at its subsidiary Priovant Therapeutics. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing with the U.S. Securities Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 8.01 Other Events.

On September 17, 2025, the Company posted a presentation regarding the results from the Phase 3 VALOR study on the “Events & Presentations” page of its investor relations website at https://investor.roivant.com and will host a conference call and webcast to discuss the results at 8:00 a.m. E.D.T. on September 17, 2025. A copy of the presentation to be used by the Company during the conference call is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The contents of the Company’s website referenced in this Current Report on Form 8-K are not incorporated into this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description of Exhibit
99.1		Press Release, dated September 17, 2025.
99.2		Presentation, dated September 17, 2025.
104		Cover Page Interactive Data File (embedded with 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.

ROIVANT SCIENCES LTD.
By:	/s/ Keyur Parekh
Name: Keyur Parekh
Title: Authorized Signatory
Dated: September 17, 2025