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Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026 and Provides Business Update
IMVT-1402 showed clinically meaningful response rates of 72.7% ACR20, 54.5% ACR50 and 35.8% ACR70 at Week 16 in the open label period of its trial in difficult-to-treat rheumatoid arthritis (D2T RA); Immunovant will provide further updates on this program in the second half of calendar year 2026 Brepocitinib granted Breakthrough Therapy Designation for the treatment of cutaneous sarcoidosis (CS) based on positive Phase 2 data; potentially registrational trial of brepocitinib in lichen planopilar
About this update from Roivant Sciences Ltd.
BASEL, Switzerland and LONDON and NEW YORK, May 20, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the fourth quarter and fiscal year ended March 31, 2026, and provided a business update. “The positive Period 1 data from the IMVT-1402 trial in D2T RA demonstrate exciting potential for a new, differentiated mechanism to treat RA patients who have failed multiple prior therapies,” said Matt Gline, CEO of Roivant. “Receiving Breakthrough Therapy Designation from the FDA for brepocitinib in cutaneous sarcoidosis underscores the potentially meaningful opportunity that program could represent for patients in need. I am looking forward to building on this momentum in the second half of 2026, with brepocitinib expected to launch in DM by the end of September, and a number of upcoming clinical readouts, including data in NIU, CLE and PH-ILD, and further updates from the D2T RA trial later this year.” Preliminary Results from IMVT-1402 Trial in D2T RA The trial evaluating IMVT-1402 in participants with D2T RA who have failed two or more prior mechanisms of advanced therapies (including biologic and targeted synthetic DMARDs) is currently ongoing. A total of 170 participants have been enrolled in the initial 16-week open label period (Period 1) of the study evaluating weekly subcutaneous (SC) dosing of IMVT-1402 600 mg. Participants achieving a response at Week 14 and Week 16 in Period 1 per the American College of Rheumatology response criteria 20 (ACR20) will be randomized in a 1:1:1 ratio to receive blinded treatment in Period 2 with either IMVT-1402 600 mg, IMVT-1402 300 mg or placebo, weekly SC for 12 weeks. The primary endpoint will assess the proportion of such participants who maintain the ACR20 response at Week 28. ACR20 response is defined as a ≥ 20% improvement from baseline in tender joint count and swollen joint count and a ≥ 20% improvement from baseline in at least 3 of 5 additional clinical parameters. Similarly, ACR50 and ACR70 responses are a calculation of 50% or 70% improvement, respectively, in the number of swollen and tender joints and 3 of 5 assessment parameters. At the completion of Period 1, 165 of the 170 patients were evaluable for ACR20 response. Of these patients, 86.7% (143/165) had failed two prior mechanisms of advanced therapies, and the mean time since diagnosis was 12.8 years. Baseli...
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