Brepocitinib

Immunovant’s batoclimab failed in two late-stage trials in thyroid eye disease (TED). It already said it probably wasn’t going to advance the drug further in a similar condition called Graves’ disease. The company said Thursday it would discuss batoclimab’s future with its partner, the South Korean drugmaker HanAll Biopharma. The Phase 3 trials, called GO-1 and GO-2, were designed to show that batoclimab could improve a TED symptom called proptosis, where the patient’s eyes bulge from their sockets. Patients were given a 680 mg injection of the drug every week for three months, followed by half that dose for the same period. At the six-month mark, the proptosis improvement endpoint was not met. Immunovant did say that batoclimab recipients had more of an improvement on the proptosis measure after the study’s high-dose period than they did after the subsequent low-dose period, suggesting a dose response. The company’s shares $IMVT were down by as much as 11% in premarket trading Thursday. Immunovant said in September that it was focusing its Graves’ disease efforts on a next-generation candidate with the same mechanism as batoclimab, known as IMVT-1402. A year ago, it also said it was dropping batoclimab in the autoimmune disorder myasthenia gravis, again in favor of IMVT-1402. Both candidates aim to block the neonatal Fc receptor, which should reduce circulating levels of pathogenic IgG autoantibodies and combat IgG-mediated diseases like TED and Graves. IMVT-1402 is in Phase 2 trials in Graves’ disease, which Immunovant said are potentially registrational. Investors will get the chance to see whether this product works better than its predecessor when the first data from those trials emerge next year. Meanwhile, another company under Roivant’s “vant” umbrella, Priovant, said Thursday it had started a Phase 2b/3 trial of a drug called brepocitinib, which could support the drug’s approval in the scalp condition lichen planopilaris (LPP). In LPP, hair follicles are destroyed and replaced with scar tissue, causing itching or burning sensations and permanent hair loss. The disorder can also increase the risk of other autoimmune diseases and skin cancers. It mostly affects people aged 40 to 60 and is more common in women than men, and Priovant said roughly 100,000 US adults have LPP. There are no approved treatments. Brepocitinib is a dual JAK1/TYK2 inhibitor. It is due an approval decision in the third quarter of this year for the inflammatory condition dermatomyositis. Priovant said it could launch in in September. The drug is also being researched in non-infectious uveitis and cutaneous sarcoidosis. Editor’s note: This article was updated to include Immunovant’s share price change.

Lichen planopilaris (LPP) is a highly morbid inflammatory scalp disorder that causes generally irreversible scarring hair loss, often accompanied by profound pain, itch, and burning sensations; no FDA-approved therapies exist for LPP, highlighting a critical unmet therapeutic need LPP marks the fourth indication in brepocitinib’s expanding late-stage development program Multiple lines of evidence, including strong mechanistic rationale and clinically meaningful results in an investigator-initiated placebo-controlled study of brepocitinib in LPP, support rapid development of brepocitinib in this indication A seamless Phase 2b/3 potentially registrational trial of brepocitinib in LPP enrolled its first subjects in March 2026 Immunovant’s Phase 3 studies of batoclimab in thyroid eye disease (TED) each failed to meet their primary endpoint; safety results were consistent with previous findings Patients in the TED studies demonstrated greater levels of proptosis improvement from baseline after the initial 12-week high-dose period than after the following 12-week low-dose period, supporting the benefit of deeper IgG suppression. The hyperthyroid patients in the TED studies showed similar response rates of thyroid hormone normalization to those seen in the batoclimab Phase 2 study in Graves’ disease Immunovant remains focused on rapid advancement of IMVT-1402 in multiple indications Roivant will host an investor call to discuss these updates today, April 2, 2026, at 8:00 a.m. ET BASEL, Switzerland and LONDON and NEW YORK, April 02, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced a new Phase 2b/3 clinical program for brepocitinib in lichen planopilaris (LPP), a highly morbid inflammatory scalp disorder affecting approximately 100,000 adults in the United States, and reported the topline results from Immunovant’s two Phase 3 (GO) clinical studies evaluating batoclimab as an investigational treatment for adults with active, moderate-to-severe thyroid eye disease (TED). Brepocitinib in LPP LPP inflammation targets the stem cell-rich bulge region of the hair follicle (the permanent portion responsible for hair growth), resulting in generally irreversible hair loss and permanent scarring. LPP is also associated with other burdensome symptoms, including pain, burning, itching, and scaling and an increased risk of comorbidities such as other autoimmune diseases and skin cancers. There are currently no FDA-approved therapies to treat LPP. “Lichen planopilaris (LPP) is what my colleagues and I refer to as a ‘trichologic emergency,’” said Dr. Kristen Lo Sicco, Chief of the Skin and Cancer Unit at NYU Langone Health, Board Member of the Scarring Alopecia Foundation, and Associate Professor of Dermatology at the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine. “Absent early diagnosis and aggressive intervention, patients experience rapid hair loss that is generally irreversible, leaves permanent scarring, and is often accompanied by erythema, scaling, pain, itching and burning sensations. Untreated LPP also leads to increased risk of skin cancers and other comorbidities. Efficacious FDA-approved treatments are urgently needed.” Priovant recently began enrolling subjects in a seamless Phase 2b/3 study of brepocitinib in LPP, with the first subjects enrolled in March 2026. This program marks Priovant’s fourth indication in late-stage clinical development, alongside dermatomyositis (DM), non-infectious uveitis (NIU) and cutaneous sarcoidosis (CS). The U.S. Food and Drug Administration (FDA) recently granted Priority Review to brepocitinib’s New Drug Application (NDA) for DM and assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of calendar year 2026. Topline Phase 3 data in NIU and Phase 3 study initiation in CS are expected in the second half of calendar year 2026. “Expanding brepocitinib into lichen planopilaris continues our strategy of developing brepocitinib in highly morbid orphan conditions with limited treatment options and distinctive mechanistic benefits of dual JAK1/TYK2 inhibition,” said Ben Zimmer, Priovant CEO. “Moreover, as we look ahead to our expected product launch in DM in September, we see LPP as a strategic fit into a multi-indication rheum-derm rare disease franchise anchored by DM, with overlapping prescriber bases and thought leaders.” Immunovant Phase 3 Studies in TED Based on the pre-specified statistical analysis plan, the studies failed to meet their primary endpoint of ≥2mm proptosis responder rate at Week 24, following 12 weeks of high-dose and 12 weeks of low-dose batoclimab treatment. Safety results were consistent with previous findings, and no new safety signals were identified. Patients in the TED studies had greater levels of proptosis improvement from baseline after the initial 12-week high-dose period than after the following 12-week low-dose period, supporting the benefit of deeper IgG suppression. The subset of hyperthyroid patients in the TED studies showed similar response rates of thyroid hormone normalization to those seen in the batoclimab Phase 2 study in Graves’ disease. Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402, an investigational FcRn blocker, across multiple autoimmune diseases with significant unmet need, with Graves’ disease as a key strategic priority. Recent Phase 2 proof-of-concept data highlighted FcRn blockade as a potentially disease-modifying approach in Graves’ disease. Topline data from the potentially registrational studies of IMVT-1402 in Graves’ disease are expected in calendar year 2027. Immunovant intends to review future plans for the development of batoclimab with its partner HanAll Biopharma Co., Ltd. (HanAll) and to provide an update on the program, in conjunction with HanAll, at a future date. Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, April 2, 2026, to discuss these updates. To access the conference call by phone, please register online using this registration link . The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at The archived webcast will be available on Roivant’s website after the conference call. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of JAK1 and TYK2 in development for the treatment of dermatomyositis, non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit Roivant Forward-Looking Statements This press release contains forward-looking statements. 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