隶属于 Roivant Sciences
Immunovant, Inc. is a clinical-stage biopharmaceutical company, which focuses on enabling normal lives for patients with autoimmune diseases. It is developing a novel, fully human monoclonal antibody IMVT-1401 that selectively binds to and inhibits the neonatal fragment crystallizable receptor. The company was founded in 2018 and is headquartered in New York, NY.
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2018
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- Sling Therapeutics raised a $123 million Series C led by Forbion to fund a late-stage trial of its oral thyroid eye disease drug linsitinib. - The global Phase 3 'Orbit' study will enroll about 130 adults with moderate-to-severe active TED, dosed at 150 mg or placebo twice daily for 24 weeks. - An earlier late-stage trial showed a statistically significant 52% response rate at 24 weeks with no drug-related hearing loss or tinnitus reported. - If approved, linsitinib would be the first oral therapy for TED, offering an alternative to injected IGF-1R antibodies Tepezza and Lumvoa.
- Immunovant's FcRn blocker batoclimab failed to meet primary efficacy endpoints in two Phase 3 trials (GO-1 and GO-2) for thyroid eye disease, despite showing some improvement in eye bulging symptoms. - The drug demonstrated efficacy during the initial 12-week high-dose stage but missed targets in the subsequent 12-week low-dose phase, supporting the need for deeper IgG suppression according to the company. - Immunovant shares declined approximately 6% following the announcement, though the modest impact reflects the company's shifted focus toward its next-generation FcRn blocker IMVT-1402. - The company will review future plans for batoclimab with development partner HanAll Biopharma, while prioritizing IMVT-1402 which offers similar IgG reduction without affecting albumin and LDL cholesterol levels.
- Roivant announces accelerated timelines for four key programs, with brepocitinib NDA filing in dermatomyositis expected in early 2026 and commercial launch anticipated in early 2027. - The company's Phase 3 trial for brepocitinib in non-infectious uveitis reached full enrollment ahead of schedule, with topline data now expected in the second half of 2026. - Immunovant secured approximately $550 million in financing to extend cash runway to the launch of IMVT-1402 in Graves' disease, while the difficult-to-treat rheumatoid arthritis trial timeline was accelerated. - Roivant projects 3+ launches, 4+ NDA/BLA filings, and 8+ pivotal study readouts over the next three years as it enters a transformational phase of growth.
- Novartis reported positive Phase III VAYHIT2 trial results showing ianalumab plus eltrombopag prolonged immune thrombocytopenia disease control by 45% compared to placebo. - The combination therapy achieved a median time to treatment failure of 13.0 months, 2.8 times longer than the 4.7 months observed with placebo plus eltrombopag. - Multiple pharmaceutical companies are advancing ITP treatments through clinical trials, with over 30 companies developing 30+ pipeline therapies for this autoimmune bleeding disorder. - Recent clinical trial initiations include studies by Incyte, argenx, and Eli Lilly evaluating novel therapeutic approaches for primary immune thrombocytopenia.
- Immunovant's batoclimab demonstrated sustained efficacy in uncontrolled Graves' disease patients, with 80% maintaining normal thyroid function six months after completing treatment. - Of the responding patients, 50% achieved complete remission without anti-thyroid drugs, suggesting potential disease-modifying effects of FcRn blockade therapy. - Two registrational trials for IMVT-1402 are currently enrolling patients, with topline results expected in 2027 for this potentially first-in-class treatment approach. - The proof-of-concept study results will be presented at the 2025 American Thyroid Association meeting, marking a potential paradigm shift in Graves' disease treatment.
- The FDA approved nipocalimab (Imaavy) in May 2025 as the first therapy targeting the underlying cause of generalized myasthenia gravis in patients aged 12 and older with specific antibodies. - Over 20 companies are developing 22+ novel myasthenia gravis therapies, including promising candidates like Descartes-08, Telitacicept, and batoclimab showing sustained efficacy in Phase 2b and Phase 3 trials. - Recent clinical developments include Cartesian Therapeutics reporting 12-month sustained improvement with Descartes-08 and RemeGen sharing positive Phase 3 results for Telitacicept at the 2025 AAN Annual Meeting.
- Merida Biosciences has secured $121 million in Series A financing co-led by Bain Capital Life Sciences, BVF Partners, and Third Rock Ventures to develop therapeutics targeting pathogenic antibodies in autoimmune diseases. - The company's proprietary platform aims to develop Fc-based biologics that selectively eliminate harmful antibodies while sparing healthy immune components, with lead programs focusing on Graves' disease, food allergies, and primary membranous nephropathy. - Former Apellis Pharmaceuticals COO Adam Townsend will lead Merida as CEO, positioning the company's approach as potentially offering more targeted alternatives to current treatments without broad immunosuppression.
- Immunovant has decided not to pursue regulatory approval for its rare disease treatment despite achieving positive results in Phase 3 clinical trials. - The decision represents a significant strategic shift for the company, potentially impacting patients awaiting new therapeutic options for this rare condition. - Industry analysts speculate the move may be related to competitive market dynamics or unexpected safety signals that emerged during late-stage development.
- Immunovant's batoclimab demonstrated statistically significant improvement in myasthenia gravis symptoms in Phase III trial, with high-dose patients showing a 5.6-point improvement on the MG-ADL scale versus 3.6 points for placebo. - Despite positive clinical outcomes, Immunovant announced it will not pursue regulatory approval for batoclimab in myasthenia gravis or chronic inflammatory demyelinating polyneuropathy due to competitive market pressures. - The company is pivoting resources to its next-generation anti-FcRn antibody IMVT-1402, with pivotal trials expected to begin imminently for both myasthenia gravis and CIDP indications.
- Immunovant is poised to release crucial Phase 3 trial results for batoclimab in generalized myasthenia gravis by March end, with analysts maintaining a Buy rating and $50 price target. - The company's strategic approach focuses on demonstrating superior efficacy of high-dose batoclimab compared to other FcRn inhibitors, targeting significant improvements in MG-ADL and QMG scores. - Development of next-generation IMVT-1402 shows promise in addressing batoclimab's effects on albumin and LDL levels, positioning Immunovant for potential market leadership.
