Welcome to our dedicated page for Roivant Sciences news (Ticker: ROIV), a resource for investors and traders seeking the latest updates and insights on Roivant Sciences stock.
Roivant Sciences (ROIV) is a commercial-stage biopharmaceutical company pioneering accelerated drug development through its innovative 'vant' subsidiary model. This dedicated news hub provides investors and industry stakeholders with timely updates on clinical milestones, regulatory developments, and strategic partnerships.
Our curated collection of ROIV press releases and verified news articles serves as a comprehensive resource for tracking the company's progress in immunology, dermatology, and autoimmune therapeutics. Users will find updates spanning clinical trial results, FDA communications, licensing agreements, and operational developments across Roivant's network of specialized subsidiaries.
The page features essential updates including new drug applications, partnership announcements with academic institutions, and pipeline expansion into novel therapeutic areas. All content is organized chronologically to help users monitor the company's execution of its unique drug development strategy.
Bookmark this page for direct access to primary source materials from Roivant Sciences, including SEC filings and peer-reviewed research collaborations. Check regularly for updates on how the company's agile approach continues to reshape biopharmaceutical innovation.
Immunovant (IMVT) announced significant leadership changes and expansion of its IMVT-1402 development program. Eric Venker, M.D., currently President and COO of Roivant, has been appointed as Immunovant's CEO, replacing Pete Salzmann who retired from his role as CEO and Director. Additionally, Tiago Girao was appointed as CFO, succeeding Renee Barnett.
The company revealed two new indications for IMVT-1402: Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE). An IND has been cleared for a potentially registrational program in SjD, with studies expected to begin in summer 2025. A proof-of-concept study has been initiated in CLE, marking the drug's sixth indication.
The company confirms its current cash balance will support operations through the expected Graves' Disease readout in 2027. These changes are part of a broader strategic transition with Roivant increasing its operational involvement and strategic oversight of Immunovant.
Immunovant (IMVT) has announced positive results from two key clinical studies. The Phase 3 study of batoclimab in Myasthenia Gravis (MG) met its primary endpoint, showing significant improvements in MG-ADL scores: a 5.6-point improvement in the higher dose arm (74% IgG reduction) and a 4.7-point improvement in the lower dose arm (64% IgG reduction).
The initial results from Period 1 of the Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 2b study demonstrated an average improvement of 1.8 in adjusted INCAT disability scores across batoclimab arms. Notably, an 84% responder rate was observed in patients achieving over 70% IgG reduction.
Both studies confirmed that deeper IgG reductions correlated with better clinical outcomes. The company plans to initiate pivotal studies for their lead asset IMVT-1402 in both MG and CIDP indications.
Roivant has scheduled an important investor webcast for Wednesday, March 19, 2025, at 8:00 AM ET to discuss important clinical trial results. The presentation will focus on two key areas:
- Results from the Phase 3 study of batoclimab in Myasthenia Gravis (MG)
- Initial findings from the Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The webcast will feature presentations from Pete Salzmann, CEO of Immunovant, and Matt Gline, CEO of Roivant. Investors can register for the event through the company's website, and the presentation will be archived for future viewing under the 'Events & Presentations' section at investor.roivant.com/news-events/events.
Roivant (ROIV) reported financial results for Q3 2024 with consolidated cash, equivalents, restricted cash, and marketable securities of $5.2 billion. The company announced expansion of brepocitinib development into cutaneous sarcoidosis, with Phase 2 study initiation expected in Q2 2025.
Key financial metrics include R&D expenses increasing to $141.6 million from $108.1 million year-over-year, and G&A expenses rising to $141.5 million from $128.2 million. The company reported a loss from continuing operations of $208.9 million, compared to income of $5.1 billion in the same period last year.
Notable developments include Immunovant's $450 million private placement, bringing Roivant's ownership to 57%, and the initiation of pivotal trials for IMVT-1402 in Graves' disease and rheumatoid arthritis. Multiple clinical milestones are expected in 2025, including batoclimab results in myasthenia gravis and CIDP by March 31, 2025.
Zest Health has secured $13 million in seed funding to address unnecessary pharmaceutical spending in dermatology care. The company focuses on treating inflammatory skin diseases through a value-based virtual care platform. With approximately 40 million Americans affected by eczema and psoriasis facing long wait times, Zest aims to reduce reliance on expensive biologics, which currently drive over $40B in annual US spend and are growing at 15% annually.
The company's virtual platform delivers personalized care, combining prescription medications, over-the-counter solutions, and lifestyle interventions. Key performance metrics include: 80% of patients showing disease improvement based on BSA and DLQI measures, 90% patient preference rate compared to prior care, and an NPS of 83. The funding, provided by Roivant Health, will support scaling partnerships with health plans and employers.
Roivant (ROIV) has scheduled a conference call and webcast for Monday, February 10, 2025, at 8:00 a.m. ET to discuss its financial results for the third quarter ended December 31, 2024, along with a business update. Interested participants can register for the phone conference through an online registration link. The presentation materials and webcast access will be available in the Investors section of Roivant's website under 'Events & Presentations'. Following the live event, an archived version of the webcast will be accessible on the company's website.
Kinevant Sciences announced that its Phase 2 RESOLVE-Lung study of namilumab failed to demonstrate treatment benefits in patients with chronic active pulmonary sarcoidosis. The study evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered monthly via subcutaneous injection. The treatment failed to meet both its primary endpoint regarding Rescue Events and secondary endpoints, including changes in forced vital capacity, corticosteroid tapering success, and patient-reported outcomes. Following these results, Kinevant will discontinue further development of namilumab for sarcoidosis treatment but commits to publishing the study results to support future research.
Roivant Sciences announced that its Phase 2 RESOLVE-Lung study of namilumab in chronic active pulmonary sarcoidosis failed to meet its primary and secondary endpoints. The study evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered monthly via subcutaneous injection. The primary endpoint measuring the proportion of subjects with a Rescue Event during the double-blind period was not met. Secondary endpoints, including changes in forced vital capacity, corticosteroid tapering success, and patient-reported outcomes, also showed no treatment benefit. As a result, Kinevant Sciences will discontinue further development of namilumab for sarcoidosis treatment.
Roivant Sciences reported Q2 2024 financial results and business updates. Key highlights include positive 52-week data from brepocitinib Phase 2 NEPTUNE study in non-infectious uveitis, FDA clearance of five IND applications for IMVT-1402, and the introduction of mosliciguat for pulmonary hypertension. The company closed Dermavant's sale to Organon for $184M cash, with potential additional milestone payments. Financial results show consolidated cash and marketable securities of $5.4B, R&D expenses of $143.1M (up from $114.8M YoY), and a net loss from continuing operations of $236.8M. The company continued share repurchases with $106M for the quarter.
Roivant (ROIV) has announced it will host a conference call and webcast on Tuesday, November 12, 2024, at 8:00 a.m. ET to discuss its financial results for the second quarter ended September 30, 2024, along with a business update. Interested participants can register online for the phone conference, and presentation materials will be accessible through the Investors section of Roivant's website. The webcast recording will be available for later viewing on the company's website.
