01—Abstract
Summary
Summary of the 8-K filed August 27, 2026. Cited figures are marked; the original filing is the authoritative source.
Roivant Sciences Ltd. (Nasdaq: ROIV) announced in an 8-K filed August 27, 2026 that the U.S. Food and Drug Administration has approved LISRAYA™ (brepocitinib) 30 mg, a once-daily pill, for the treatment of adults with dermatomyositis (DM).
The New Drug Application was submitted by the company's subsidiary, Priovant Therapeutics, Inc. The press release states the drug is available immediately in the U.S. through a limited specialty pharmacy distribution network, and that eligible patients may pay as little as $0a per month through the LISRAYA My Compass Support program. The filing cites results from the Phase 3 VALOR trial, which the company describes as the largest DM trial ever conducted. Per the release, 55% of LISRAYA-treated patients achieved moderate or better improvement on the myositis Total Improvement Score and minimal or no steroid use by the end of the 52-week study, compared with 30% on placebo.
Among patients taking at least 7.5 mg/day of oral corticosteroids at baseline, 62%b tapered to 2.5 mg/day or less, compared with 38% on placebo. The label carries a boxed warning covering serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. The company also stated that its late-stage programs in non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris continue, and that it will host an investor conference call at 8:00 a.m.
ET on August 28, 2026. The press release is furnished under Item 7.01 and is not deemed filed for purposes of Section 18 of the Exchange Act.
02—Key points
Key Highlights
- FDA approved LISRAYA™ (brepocitinib) 30 mg, a once-daily pill, for adults with dermatomyositis; the product is available immediately in the U.S.
- The approval was granted following Priority Review and Orphan Drug Designation, and the application was submitted by subsidiary Priovant Therapeutics, Inc.
- In the Phase 3 VALOR trial, 55% of LISRAYA patients achieved moderate or better Total Improvement Score improvement and minimal or no steroid use by week 52, versus 30% on placebo.
- Among patients on at least 7.5 mg/day prednisone-equivalent at baseline, 62% tapered to 2.5 mg/day or less on LISRAYA versus 38% on placebo; 45% discontinued corticosteroids entirely versus 29% on placebo.
- The label includes a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.
- Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.
- Roivant will hold an investor call at 8:00 a.m. ET on August 28, 2026 to discuss the update.
03—Questions
Frequently Asked Questions
What did the FDA approve?
The FDA approved LISRAYA™ (brepocitinib) 30 mg for the treatment of adults with dermatomyositis (DM). It is taken as a once-daily pill, and the company describes it as a first-in-class TYK2/JAK1 inhibitor and the first and only targeted therapy approved for dermatomyositis.
What clinical data support the approval?
The approval followed the Phase 3 VALOR trial, which the company describes as the largest DM trial ever conducted. Primary results were published in the New England Journal of Medicine in March 2026, and additional skin-specific secondary endpoints were published in JAMA Dermatology in August 2026. Benefits on the primary endpoint were seen as early as Week 4 and sustained through the 52-week study.
What are the main safety concerns?
The label carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis. Other warnings include hypersensitivity, gastrointestinal perforation, hypoglycemia in patients with diabetes, laboratory abnormalities, and embryofetal toxicity. The most common adverse reactions were upper respiratory tract infection, headache, fatigue and urinary tract infection.
How will patients access LISRAYA and what will it cost?
LISRAYA is available immediately in the U.S. through a limited distribution network of specialty pharmacies. Prescriptions can be submitted at lisrayahcp.com/enroll. Through the LISRAYA My Compass Support program, which offers insurance and financial assistance help, eligible patients may pay as little as $0 per month.
What are the company's other pipeline priorities?
According to the press release, Roivant continues to advance late-stage programs for brepocitinib in non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris. The release also lists IMVT-1402, an FcRn-targeting antibody, and mosliciguat, an inhaled sGC activator, as other pipeline assets.
04—Continue