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Roivant Named on Fortune Media and Great Place To Work's 2025 Best Workplaces in BioPharma List
Globenewswire· 2025-09-11 20:30
Group 1 - Roivant has been recognized as one of the 2025 Fortune Best Workplaces in BioPharma, ranking 28th in the small & medium category, marking its first appearance on this prestigious list [1][3] - The award is based on survey responses from nearly 40,000 employees at Great Place To Work Certified companies in the biotechnology and pharmaceutical industry, reflecting a comprehensive picture of workplace experiences [2][4] - The selection process involved over 1.3 million survey responses from employees across the U.S., with rankings derived from 60 employee experience questions within the Great Place To Work Trust Index™ Survey [5] Group 2 - The recognition highlights Roivant's commitment to fostering an empowering, high-performance, and talent-oriented culture, as stated by the CEO [3] - The Best Workplaces in BioPharma list is highly competitive, with companies evaluated on their ability to provide positive outcomes for employees across various demographic identifiers [4][5] - Roivant is a biopharmaceutical company focused on accelerating the development and commercialization of impactful medicines, with a diverse pipeline targeting various medical conditions [10][11]
Roivant Sciences Ltd. (ROIV) Wins Orphan Drug Status in Japan for Mosliciguat
Yahoo Finance· 2025-09-11 15:11
Core Insights - Roivant Sciences Ltd. is highlighted as a promising investment opportunity in the healthcare sector, particularly in the biopharmaceutical space [1][4] Company Overview - Roivant Sciences Ltd. (NASDAQ:ROIV) is a clinical-stage biopharmaceutical company that accelerates the development of medicines through its subsidiaries, known as "Vants" [2] - The company focuses on in-licensing drug candidates from larger pharmaceutical firms and advancing them toward commercialization [2] Pipeline and Recent Developments - The current pipeline includes mosliciguat for pulmonary hypertension, brepocitinib for inflammatory diseases, and IMVT-1402 targeting autoimmune conditions [2] - A significant milestone for Roivant is the advancement of mosliciguat, which has received orphan drug designation in Japan, providing regulatory benefits and potential market exclusivity [3] - The Pulmovant subsidiary is positioned to address an underserved market in pulmonary hypertension with limited treatment options [3] Strategic Focus and Market Position - Roivant's brepocitinib program is progressing toward critical Phase 3 data readouts, which is fostering optimism among investors and analysts [4] - The company's strategic focus on rare and immune-mediated diseases enhances its attractiveness as a high-potential biotech investment [4]
Pulmovant Receives Orphan Drug Designation in Japan for Mosliciguat for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Newsfilter· 2025-09-04 11:00
Core Insights - Pulmovant has received orphan drug designation for mosliciguat from Japan's Ministry of Health, Labour and Welfare, highlighting the significant unmet medical need for patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) [1][2] - Mosliciguat is a novel, once-daily, inhaled soluble guanylate cyclase (sGC) activator currently in Phase 2 clinical trials, aiming to provide a targeted treatment option for PH-ILD [1][3] Company Overview - Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases and is a subsidiary of Roivant [7] - The company’s lead candidate, mosliciguat, is designed to be a first-in-class inhaled treatment for PH-ILD, with a differentiated mechanism of action [7][5] Clinical Development - Mosliciguat is currently being evaluated in the Phase 2 PHocus clinical study, which is a randomized, double-blind, placebo-controlled trial involving approximately 120 adult patients [3][6] - The Phase 1b ATMOS study demonstrated that inhaled mosliciguat was well tolerated and resulted in a mean peak reduction in pulmonary vascular resistance (PVR) of up to 38% [5] Market Context - PH-ILD is a progressive and life-threatening condition affecting up to 200,000 patients in the U.S. and Europe, with limited or no approved treatment options available [4] - The orphan drug designation provides Pulmovant with regulatory benefits, including priority consultation and up to 10 years of market exclusivity post-approval [2][6]
Roivant Sciences(ROIV) - 2026 Q1 - Earnings Call Presentation
2025-08-11 12:00
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]
Roivant Reports Financial Results for the First Quarter Ended June 30, 2025, and Provides Business Update
Globenewswire· 2025-08-11 11:00
Core Insights - Roivant reported financial results for Q1 ended June 30, 2025, highlighting clinical progress and a completed $1.5 billion share repurchase program [1][2] - The company is preparing for the potential launch of brepocitinib, which targets high unmet medical needs [2][4] Recent Developments - The VALOR Phase 3 study for brepocitinib in dermatomyositis is on track for topline data readout in H2 2025, with the last patient visit completed in July [4][5] - Rapid enrollment is ongoing for brepocitinib in non-infectious uveitis and cutaneous sarcoidosis, with readouts expected in H1 2027 and H2 2026, respectively [4][5] - Immunovant initiated two potentially registrational studies for IMVT-1402 in Graves' disease and Sjögren's disease in June 2025 [5] Financial Summary - As of June 30, 2025, Roivant had consolidated cash, cash equivalents, restricted cash, and marketable securities totaling approximately $4.5 billion [6][8] - Research and development expenses increased by $32.4 million to $152.9 million compared to the same period in 2024, driven by program-specific costs and personnel-related expenses [9][10] - General and administrative expenses rose by $34.1 million to $134.0 million, primarily due to increased share-based compensation [12][14] Share Repurchase Program - Roivant completed its initial $1.5 billion share repurchase program, including $208 million in repurchases for the quarter, reducing outstanding shares by over 15% from March 31, 2024 [4][6] - A new $500 million share repurchase program was approved by the board in June 2025 [6] Upcoming Milestones - Topline data from the ongoing Phase 3 trial of brepocitinib in dermatomyositis is expected in H2 2025 [13] - Remission data from the batoclimab proof-of-concept study in Graves' disease will be reported at the American Thyroid Association Annual Meeting in September 2025 [13]
Roivant to Report Financial Results for the First Quarter Ended June 30, 2025, and Provide Business Update on Monday, August 11, 2025
Globenewswire· 2025-07-28 20:05
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]
Roivant and Priovant to Host Investor Video Conference at 1:00 PM ET on Tuesday, June 17 on Brepocitinib and the Unmet Medical Need in Dermatomyositis
Globenewswire· 2025-06-09 20:05
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]
Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025, and Provides Business Update
Globenewswire· 2025-05-29 11:00
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]
Roivant to Report Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025 and Provide Business Update on Thursday, May 29, 2025
Globenewswire· 2025-05-15 20:10
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]