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): March 3, 2026
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
1 Pennsylvania Plaza
Floor 54
New York, NY 10119
United States1
Viaduktstrasse 8
4051 Basel
Switzerland1
(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. ☐
| 1 | Addresses of wholly-owned subsidiaries of the Registrant. |
| Item 7.01. | Regulation FD Disclosure |
On March 3, 2026, Roivant Sciences Ltd. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has accepted the New Drug Application (“NDA”) for brepocitinib for the treatment of dermatomyositis filed by the Company’s subsidiary, Priovant Therapeutics, and has granted the NDA Priority Review. 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 and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
| Item 9.01. | Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit No. | Description of Exhibit | |
| Press Release, dated March 3, 2026. | ||
| 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: March 3, 2026 | ||