Core Insights - Immunovant, Inc. (IMVT) shares increased by 10.8% following the announcement of six-month off-treatment results from a proof-of-concept study for batoclimab in patients with uncontrolled Graves' disease (GD) [1][4] - The study demonstrated that approximately 80% of patients maintained normalized thyroid hormone levels during the follow-up period, indicating strong durability of response [3][4] Study Details - The proof-of-concept study involved patients with active GD who had elevated thyroid hormone levels despite antithyroid drug (ATD) therapy. The primary endpoint was the normalization or reduction of thyroid hormone levels without increasing ATD dosage at week 24 [2] - Among the responders, about half achieved ATD-free remission, while 30% required only minimal ATD doses of 2.5 mg/day [6] Implications and Future Plans - The findings suggest that FcRn blockade may provide a promising therapeutic approach for GD, with potential for disease modification as several patients achieved durable remission after treatment withdrawal [7] - Immunovant plans to leverage the batoclimab data to expedite the development of its lead candidate, IMVT-1402, which is also aimed at treating GD [8] - The company has initiated two global studies for IMVT-1402, evaluating a 600 mg dose for up to 52 weeks, with top-line results expected in 2027 [9]

The biotech looks as if it has a promising treatment for an autoimmune disorder.Wednesday might have been a Hump Day of a slog to some investors, but not for those holding shares of Immunovant (IMVT 10.82%). On some rather encouraging news from the laboratory, the clinical-stage biotech's shares gained almost 11% in value, easily topping the 0.5% rise of the benchmark S&P 500 (^GSPC 0.51%).Proven resultsThat afternoon, Immunovant shared data from a proof-of-concept study of its batoclimab. This is an invest ...

First-ever potentially disease-modifying therapy for uncontrolled Graves’ disease patientsOf 21 patients who entered the six-month off-treatment follow-up period, ~80% (17/21) demonstrated response, resulting in normal thyroid function (T3 and T4 less than the upper limit of normal) at the end of the six-month follow-up periodOf the 17 responders to therapy, ~50% (8/17) achieved anti-thyroid drug (ATD) free remission at six months following end of batoclimab treatmentTwo potentially registrational trials fo ...

First-ever potentially disease-modifying therapy for uncontrolled Graves’ disease patientsOf 21 patients who entered the six-month off-treatment follow-up period, ~80% (17/21) demonstrated response, resulting in normal thyroid function (T3 and T4 less than the upper limit of normal) at the end of the six-month follow-up periodOf the 17 responders to therapy, ~50% (8/17) achieved anti-thyroid drug (ATD) free remission at six months following end of batoclimab treatmentTwo potentially registrational trials fo ...

Core Insights - Immunovant, Inc. reported a first-quarter fiscal 2026 adjusted net loss of $0.60 per share, which is narrower than the Zacks Consensus Estimate of a loss of $0.69 and matches the loss from the same quarter last year [1][4] Financial Performance - Research and development expenses reached $101.2 million, reflecting a 34% increase from the previous year, driven by clinical study activities for IMVT-1402 and higher personnel costs, partially offset by reduced costs in batoclimab studies [2] - General and administrative expenses were $26 million, up 38% year over year, primarily due to increased personnel-related expenses [3] - As of June 30, 2025, the company had a cash balance of $598.9 million, down from $714 million as of March 31, 2025, with expectations to fund clinical activities through 2027 [3] Pipeline Developments - IMVT-1402 is the lead drug candidate, being studied for six indications, with key data readouts expected through 2027 [4][6] - The company plans to initiate clinical studies for IMVT-1402 in a total of 10 indications by March 31, 2026, leveraging existing data from batoclimab studies for financial efficiencies [5] - During the first quarter of fiscal 2026, Immunovant initiated a second potentially registrational study of IMVT-1402 for Graves' disease and a study for Sjögren's disease [7] Upcoming Milestones - In 2026, the company plans to share open-label data from its difficult-to-treat rheumatoid arthritis study and top-line results from the cutaneous lupus erythematosus proof-of-concept study [7] - Top-line results from potentially registrational studies in difficult-to-treat rheumatoid arthritis, Graves' disease, and myasthenia gravis are expected in 2027 [7] Additional Candidates - Immunovant is also evaluating batoclimab in mid-late-stage studies for Graves' disease and thyroid eye disease, with new proof-of-concept data expected to be reported in September 2025 [8][10]

Business Highlights - Roivant completed a $1.5 billion share repurchase program in June 2025, repurchasing approximately 149 million shares at an average price of $10.09, reducing the share count by over 15%[23] - The company expanded its pipeline by initiating 6 potentially registrational studies and 3 proof-of-concept (POC) studies[23] - Roivant increased shareholder exposure to clinical and litigation catalysts over the next 36 months[23] Brepocitinib Program - Topline data from the Phase 3 VALOR study of brepocitinib in dermatomyositis (DM) is expected in the second half of 2025[20, 27] - The VALOR study enrolled 241 adults with active DM, with 38% from the US, 32% from the EU, and 30% from the rest of the world[35] - Approximately 40% of subjects taking oral corticosteroids (OCS) at baseline in the VALOR study were able to eliminate OCS entirely by the end of the study[45] LNP Litigation - Summary judgment phase is ongoing in the US Moderna case, with a jury trial scheduled for March 2026[18, 27, 52] - Ongoing progress is expected in the Pfizer/BioNTech case following the Markman hearing, with a decision potentially in 2025[18, 27, 52] Financial Update - Research and development (R&D) expense was $153 million, with an adjusted R&D expense of $141 million (non-GAAP)[58] - General and administrative (G&A) expense was $134 million, with an adjusted G&A expense of $63 million (non-GAAP)[58] - Roivant had $4.5 billion in cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2025[58]

NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for the quarter ended June 30, 2025. Recent Highlights and Upcoming Milestones: In June 2025, Immunovant initiated a second potentially registrational trial evaluating IMVT-1402 in GD and a potentially registrational trial evaluating IMVT-1402 in SjD. All clinical develop ...

BASEL, Switzerland and LONDON and NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the first quarter ended June 30, 2025, and provided a business update. "I am proud of our continued execution in this quarter, including clinical progress across our programs and the completion of our initial $1.5 billion share repurchase program," said Matt Gline, CEO of Roivant. "I am very excited for the year ahead of us – including the near-term readout of our DM ...

Company Overview - Roivant is a biopharmaceutical company focused on improving patient lives by accelerating the development and commercialization of important medicines [3] - The company's pipeline includes several product candidates such as IMVT-1402, batoclimab, brepocitinib, and mosliciguat, targeting various autoimmune and pulmonary conditions [3] Upcoming Events - Roivant will host a live conference call and webcast on August 11, 2025, at 8:00 a.m. ET to report its financial results for the first quarter ended June 30, 2025, and provide a business update [1] Access Information - Interested parties can access the conference call by registering online, with details available on Roivant's investor website [2]

Core Viewpoint - Roivant and Priovant Therapeutics are hosting a live investor video conference to discuss brepocitinib and its potential impact on patients with dermatomyositis [1] Company Overview - Priovant Therapeutics focuses on developing novel therapies for autoimmune diseases with high morbidity and limited treatment options, with brepocitinib as its lead asset [3] - Brepocitinib is a dual selective inhibitor of TYK2 and JAK1, designed to suppress key cytokines linked to autoimmunity through a single oral therapy [3] - Roivant is a biopharmaceutical company that accelerates the development and commercialization of important medicines, with a diverse pipeline including brepocitinib and other therapies targeting autoimmune conditions [4] Product Development - Brepocitinib has been dosed in over 1,400 subjects and has shown positive results in seven Phase 2 studies, currently being evaluated in Phase 3 trials for dermatomyositis and non-infectious uveitis, and Phase 2 for cutaneous sarcoidosis [3]