Priovant Therapeutics, a majority-owned subsidiary of Roivant Sciences (NASDAQ:ROIV), provided a significant update on its late-stage immunology pipeline on Thursday, April 2, 2026.
The company is aggressively expanding the clinical footprint of brepocitinib, a potent dual JAK1/TYK2 inhibitor, into orphan diseases with high unmet needs and no currently approved FDA therapies.
In a move to address a major gap in dermatological care, Priovant has launched a seamless Phase 2b/3 trial of brepocitinib in lichen planopilaris (LPP).
The study enrolled its first subjects in March 2026.
LPP is a rare, inflammatory autoimmune condition that causes permanent scarring hair loss and is estimated to affect approximately 100,000 adults in the United States.
By utilizing a seamless trial design, the company aims to accelerate the transition from dose-finding to registrational data, potentially shortening the path to a New Drug Application (NDA).
Simultaneously, the company reached a critical regulatory milestone for its most advanced program.
The FDA has granted Priority Review to the NDA for brepocitinib in dermatomyositis (DM).
The agency has assigned a PDUFA target action date in the third quarter of 2026, positioning the therapy to potentially become the first oral treatment approved for this debilitating multi-system inflammatory disease.
Beyond LPP and DM, brepocitinib is being evaluated across a broad spectrum of high-unmet-need indications.
Topline data from the Phase 3 trial in non-infectious uveitis (NIU) is expected in the second half of 2026, alongside the planned initiation of a Phase 3 study in cutaneous sarcoidosis (CS).