IMVT Immunovant

brepocitinib · NCT05437263 registry update

status: ACTIVE_NOT_RECRUITING → COMPLETED; completion: 2026-07 → 2026-09-09

Roivant announces FDA approval of LISRAYA (brepocitinib) for dermatomyositis

FDA approved brepocitinib (LISRAYA) 30 mg once daily for adults with dermatomyositis, making it the first targeted therapy approved for this indication. The approval is effective immediately and the drug is now available in the U.S. through specialty pharmacies. The approval follows the Phase 3 VALOR trial, which demonstrated robust efficacy across multiple disease measures and substantial steroid-sparing benefits.

Roivant Sciences Ltd. · FDA approves Lisraya (brepocitinib)

FDA lists Lisraya (brepocitinib) as novel drug approval #35 of 2026 on 2026-08-27: To treat dermatomyositis in adults

Roivant: brepocitinib granted Breakthrough Therapy Designation for cutaneous sarcoidosis

The FDA granted brepocitinib Breakthrough Therapy Designation for cutaneous sarcoidosis based on positive Phase 2 BEACON study data. This designation provides a potentially expedited regulatory path for the asset in this indication. A Phase 3 program in CS is planned to start in the second half of calendar year 2026.

Roivant expands brepocitinib program with new LPP Phase 2b/3 trial

Roivant initiated a seamless Phase 2b/3 trial of brepocitinib in lichen planopilaris (LPP), marking the fourth late-stage indication for the asset. The first subjects were enrolled in March 2026. Separately, Immunovant’s two Phase 3 studies of batoclimab in thyroid eye disease failed to meet their primary endpoint.

Priovant: FDA accepts NDA for brepocitinib in dermatomyositis, Priority Review

FDA has accepted the NDA for brepocitinib in dermatomyositis and granted Priority Review. The agency set a PDUFA target action date in Q3 2026, with launch expected end of September 2026. The filing is supported by the positive Phase 3 VALOR trial, the first 52-week placebo-controlled study in dermatomyositis.

Roivant: brepocitinib Phase 2 BEACON met primary endpoint in cutaneous sarcoidosis

Positive Phase 2 topline data show brepocitinib 45 mg produced statistically significant, clinically meaningful improvement in cutaneous sarcoidosis activity versus placebo. Priovant plans to advance the program into a Phase 3 pivotal study in 2026, making cutaneous sarcoidosis the third indication with a pivotal program for brepocitinib.

Roivant accelerates brepocitinib and IMVT-1402 timelines at 2025 Investor Day

Roivant updated timing guidance for four key programs, accelerating brepocitinib NDA filing in DM to early 2026, NIU Phase 3 topline to H2 2026, CS proof-of-concept topline to H1 2026, and IMVT-1402 D2T RA topline to 2026. The company also announced a $550 million Immunovant financing extending cash runway to IMVT-1402 launch in Graves' disease.