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
 
Press Release, dated September 17, 2025.
 
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