Roivant Sciences Ltd. filed a Form 8-K on August 27, 2026, disclosing that the U.S. Food and Drug Administration approved the New Drug Application for LISRAYA (brepocitinib) for the treatment of adults with dermatomyositis.

Key Highlights

  • FDA approval granted: The U.S. Food and Drug Administration approved the New Drug Application for LISRAYA (brepocitinib) for adults with dermatomyositis.
  • Subsidiary applicant: The NDA was submitted by Priovant Therapeutics, Inc., a subsidiary of Roivant Sciences Ltd.
  • Announcement date: Roivant issued a press release on August 27, 2026, announcing the approval.
  • Disclosure method: The press release was furnished under Regulation FD as Exhibit 99.1 and incorporated by reference into the filing.
  • Exchange listing: Roivant Sciences Ltd. common shares trade on NASDAQ:ROIV.

Roivant Sciences Discloses FDA Approval of LISRAYA (Brepocitinib) for Dermatomyositis

According to the filing, Roivant Sciences Ltd. (NASDAQ:ROIV) reported that the U.S. Food and Drug Administration approved the New Drug Application for LISRAYA, the brand name for brepocitinib, for use in adults diagnosed with dermatomyositis. The approval was announced by the company via a press release dated August 27, 2026, which was attached to the filing as Exhibit 99.1.

The filing states that the NDA was submitted by Priovant Therapeutics, Inc., identified in the disclosure as a subsidiary of Roivant Sciences Ltd. The company disclosed the development under Item 7.01, Regulation FD Disclosure. As noted in the filing, the information furnished under Item 7.01, including Exhibit 99.1, "shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934" and is not subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933.

The Form 8-K was signed by Keyur Parekh, identified as Authorized Signatory, on behalf of Roivant Sciences Ltd., a Bermuda-incorporated company with principal executive offices at 7th Floor, 50 Broadway, London, SW1H 0DB, United Kingdom. Common shares of Roivant Sciences are registered on The Nasdaq Global Select Market under the trading symbol ROIV, with a par value of $0.0000000341740141 per share, as stated on the filing's cover page.

What Was Disclosed

Roivant Sciences Ltd. disclosed in an August 27, 2026 Form 8-K that the FDA approved the New Drug Application for LISRAYA (brepocitinib), submitted by subsidiary Priovant Therapeutics, Inc., for the treatment of adults with dermatomyositis.