Common Shares, $0.0000000341740141 per share
- Symbol
- ROIV
- Exchange
- NASDAQ
- Classification
- COMMON
Current Report · Items 7.01, 9.01 · 8-K
Roivant Sciences Ltd.
ROIVNASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On October 21, 2026, Roivant Sciences Ltd. (the “Company”) issued a press release announcing positive results from the Phase 3 CLARITY program evaluating brepocitinib in non-infectious uveitis (“NIU”) conducted by its subsidiary, Priovant Therapeutics, Inc. (“Priovant”).…
Company context
Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.
Current securities
Registered securities in this filing
Roivant Sciences Ltd. · 8-K · Filed 2026-10-21
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On October 21, 2026, Roivant Sciences Ltd. (the “Company”) issued a press release announcing positive results from the Phase 3 CLARITY program evaluating brepocitinib in
non-infectious uveitis (“NIU”) conducted by its subsidiary, Priovant Therapeutics, Inc. (“Priovant”). 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 SEC made
by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Filed exhibits (1)
Exhibit 99.1 Roivant and Priovant Announce Positive Results in CLARITY-1 and CLARITY-2 Phase 3 Trials for Brepocitinib in Non-Infectious Uveitis (NIU) Brepocitinib 45 mg once-daily achieved statistically significant benefit compared to placebo on the primary and all key secondary endpoints for each of CLARITY-1 and CLARITY-2, the two identical Phase 3 trials comprising the CLARITY program in NIU Median time to treatment failure for brepocitinib patients was greater than 48 weeks in both studies, compared with ~12 weeks on placebo in each study (p<0.0001 in both studies), including 40 weeks of steroid-free treatment, setting a new bar for time to failure and steroid-sparing benefit in NIU Pooled across the CLARITY studies, 62% of patients on brepocitinib achieved steroid-free quiescence at Week 48, compared with 20% on placebo (p<0.0001), with similar results in each study Of patients that entered the CLARITY studies (pooled) with macular edema, 42% of eyes on brepocitinib achieved resolution of macular edema at Week 48, compared with 4.8% on placebo (p<0.0001), with similar results in each study The magnitude and breadth of benefit observed across every ranked…
Open exhibit ↗