Immunovant, a majority-owned Roivant subsidiary, reported on September 23, 2026 that a 57-patient randomized, double-blind, placebo-controlled proof-of-concept trial of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus did not reach statistical significance on percent change in CLASI-A score at week 12. The company reported numerical trends favoring the drug and an association between deeper IgG reductions and clinical response, but said the results did not meet its internal bar and it will stop development in the indication. Trials of the FcRn inhibitor continue in Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, CIDP, and Sjögren's disease.
Roivant Sciences (NASDAQ: ROIV) subsidiary Priovant Therapeutics announced FDA approval of Lisraya (brepocitinib 30 mg once daily, a first-in-class TYK2/JAK1 dual selective inhibitor) on Thursday August 27, 2026 for adults with dermatomyositis (DM), an autoimmune inflammatory myopathy with skin involvement and few effective targeted therapies. Approval was based on the 52-week Phase 3 VALOR trial (241 patients, the longest and largest interventional DM study), where 55% of Lisraya patients achieved moderate-or-better improvement on the Total Improvement Score with minimal-or-no steroid use versus 30% on placebo. VALOR results were published in NEJM in March 2026 with dermatology secondary endpoints in JAMA Dermatology in August 2026. List price is $35,000 for a 30-day supply, with a $0/month patient support program for eligible patients. Brepocitinib was originally discovered by Pfizer and licensed to Priovant. Not a peptide; the approval matters here because dermatomyositis is one of several autoimmune indications where peptide immunomodulators (thymalfasin, thymosin alpha-1 analogs) had been discussed in earlier decades before being displaced by targeted small-molecule and biologic approaches.
Alongside the FDA approval announcement Thursday August 27, 2026, Roivant Sciences (NASDAQ: ROIV) filed an 8-K disclosure and hosted a conference call Friday August 28, 2026 confirming that Priovant Therapeutics has fielded a dermatology-and-rheumatology-focused sales force, contracted with major specialty pharmacy distributors, and secured initial payer coverage sufficient to begin U.S. commercial launch on August 28. Priovant is a Pfizer-Roivant joint venture (Roivant 75%, Pfizer 25%) that was created in 2022 specifically to advance brepocitinib in dermatomyositis, cutaneous lupus, and non-infectious uveitis. Beyond Lisraya, Priovant's brepocitinib program continues in Phase 3 for cutaneous lupus (VALIANT) with topline data expected in H1 2027 and in Phase 2 for non-infectious uveitis. The launch is a signal event for the Roivant 'Vant' model, in which spin-out subsidiaries develop and commercialize discrete assets while remaining consolidated within the parent. Not a peptide; included because the JAK/TYK2 inhibitor category continues to displace older peptide-based immunomodulation approaches in autoimmune disease.