"Obtaining orphan drug designation for mosliciguat in Japan validates the significant unmet need that exists for people living with PH-ILD, a progressive and life-threatening cardiopulmonary condition with poor prognosis and limited or no treatment options," said Drew Fromkin, Chief Executive Officer of Pulmovant. "We appreciate the MHLW's recognition of this challenge for PH-ILD patients and look forward to continued collaboration with Japanese regulators as we advance mosliciguat through the next stages o ...

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]

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]

Core Insights - Roivant reported financial results for the fourth quarter and fiscal year ended March 31, 2025, highlighting significant progress in its clinical pipeline and financial position [1][34] - The company is focused on advancing its late-stage clinical programs, particularly brepocitinib and IMVT-1402, with several upcoming milestones expected in 2025 and 2026 [2][8] Financial Summary - As of March 31, 2025, Roivant had cash, cash equivalents, restricted cash, and marketable securities totaling approximately $4.9 billion, supporting its cash runway into profitability [9][14] - Research and development (R&D) expenses for the fourth quarter increased by $37.7 million to $145.2 million compared to the same period in 2024, driven by program-specific costs and personnel-related expenses [10][11] - For the fiscal year ended March 31, 2025, R&D expenses rose by $110.5 million to $550.4 million, primarily due to increases in program-specific costs and personnel-related expenses [12][13] - General and administrative (G&A) expenses for the fourth quarter increased by $39.0 million to $147.1 million, largely due to share-based compensation expenses [17][19] - The company reported a loss from continuing operations of $252.4 million for the fourth quarter, compared to a loss of $95.0 million in the same quarter of the previous year [22] Clinical Developments - Roivant's brepocitinib program is progressing well, with rapid enrollment in a Phase 3 study for non-infectious uveitis and a proof-of-concept trial for cutaneous sarcoidosis [5][6] - Immunovant announced positive results from its batoclimab studies, with significant improvements in Myasthenia Gravis Activities of Daily Living scores and responder rates in chronic inflammatory demyelinating polyneuropathy [4][6] - The company is actively enrolling potentially registrational trials for IMVT-1402 in multiple indications, including Graves' disease and Sjögren's disease, expected to start in summer 2025 [5][7] Share Repurchase and Equity - Roivant repurchased $1.3 billion of its shares as of March 31, 2025, reducing outstanding shares by 14% from the previous year [14][21] - The company reported a net loss attributable to Roivant of $206.5 million for the fourth quarter, compared to a net loss of $151.1 million in the same quarter of the previous year [28]

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 and batoclimab for autoimmune indications, brepocitinib for various inflammatory conditions, and mosliciguat for pulmonary hypertension [3] Upcoming Events - Roivant will host a live conference call and webcast on May 29, 2025, at 8:00 a.m. ET to report its financial results for the fourth quarter and fiscal year ended March 31, 2025, and to 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]