Welcome to our dedicated page for Immunovant news (Ticker: IMVT), a resource for investors and traders seeking the latest updates and insights on Immunovant stock.
Immunovant, Inc. (Nasdaq: IMVT) is a clinical-stage biopharmaceutical firm focused on developing monoclonal antibodies for the treatment of autoimmune diseases. The company is dedicated to enabling normal lives for patients with these conditions. Their primary product candidate, IMVT-1401, is a fully human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor (FcRn). IMVT-1401 is currently in Phase IIa clinical trials for treating myasthenia gravis and thyroid eye disease, with additional trials for warm autoimmune hemolytic anemia underway.
Immunovant is also developing batoclimab and IMVT-1402, which target the same FcRn receptor to modulate the immune response. The company has recently announced promising initial Phase 1 data for IMVT-1402, showing significant IgG reduction with minimal changes in serum albumin and LDL cholesterol, pointing towards a potential best-in-class profile. With a robust pipeline and strategic partnerships, including being a subsidiary of Roivant Sciences Ltd., Immunovant is well-positioned in the biopharmaceutical sector.
Recent financial highlights underline the company's growth, with significant net proceeds from public offerings and private placements. For the fiscal quarter ended September 30, 2023, research and development expenses were $48.0 million, primarily due to the development of IMVT-1402.
In corporate updates, Immunovant recently completed a public offering and concurrent private placement, raising approximately $467 million. The company continues to expand its clinical trials and has announced plans to initiate several potentially registrational programs for IMVT-1402 by March 31, 2025. With ongoing advancements in their clinical programs and financial strength, Immunovant, Inc. stands at the forefront of innovative treatments for autoimmune diseases.
Immunovant (IMVT) reported key developments and financial results for Q2 2024. The company secured five IND clearances for its lead asset IMVT-1402 across various therapeutic areas. Plans include initiating 4-5 potentially registrational trials by March 2025, including programs in Graves' disease and difficult-to-treat rheumatoid arthritis. Financial highlights show cash position of $472.9M, with R&D expenses increasing to $97.3M from $48.0M YoY. Net loss widened to $109.1M ($0.74 per share) compared to $58.7M ($0.45 per share) in the prior year period.
Immunovant announced that data from their Phase 2a trial of batoclimab in Graves' disease will be presented at the 2024 American Thyroid Association Annual Meeting in Chicago. The late-breaking oral presentation will showcase new data on both thyroid-specific and extrathyroidal manifestations of Graves' disease. The presentation titled 'Efficacy and Safety of the FcRn Inhibitor, Batoclimab, in Graves' Thyroidal and Extrathyroidal Disease: a Proof-of-concept Study' will be delivered by Dr. George Kahaly on November 1, 2024.
Ankyra has appointed Dr. Julia G. Butchko and Ms. Tara Withington as independent board members, effective September 25, 2024. This brings the total board composition to seven directors. Dr. Butchko, with 25 years of industry experience, most recently served as Chief Development Officer at Immunovant (NASDAQ: IMVT). Ms. Withington has over 40 years of executive experience in the nonprofit sector and is currently a principal and Vice President with Executive Director, Incorporated (EDI).
Ankyra's lead asset, ANK-101, an anchored IL-12, has entered phase I clinical trials earlier this year. Over 10 patients with advanced solid cancers have been treated at multiple study sites in the United States and Canada (NCT:06171750).
Immunovant (Nasdaq: IMVT) reported positive results from its Phase 2a trial of batoclimab in Graves' Disease. Key findings include:
1. 76% response rate with high-dose batoclimab at week 12
2. 56% ATD-Free response rate at week 12
3. Strong correlation between IgG lowering and clinical outcomes
The company also announced FDA clearance for an IMVT-1402 pivotal trial in Graves' Disease, expected to start by year-end. Market research indicates 25-30% of Graves' Disease patients are uncontrolled on antithyroid drugs annually, representing a significant commercial opportunity. Immunovant believes these results validate the unmet medical need and demonstrate strong response rates in this population.
Immunovant (Nasdaq: IMVT) has announced an investor webcast scheduled for September 9, 2024, at 8:00 a.m. ET to provide updates on its Graves' Disease (GD) program. The presentation will cover:
- New epidemiologic data on the potential addressable market
- Additional results from the Phase 2 study of batoclimab
- An overview of the IMVT-1402 development program in GD
Investors can register for the event through a provided link, and a live webcast will be available on Immunovant's website. A replay of the event and presentation will be accessible immediately after the webcast concludes.
Immunovant (IMVT) reported progress in its clinical programs and financial results for Q1 FY2025 ended June 30, 2024. Key highlights include:
1. Completed enrollment in batoclimab pivotal Myasthenia Gravis (MG) trial
2. On track to initiate IMVT-1402 registrational program by March 31, 2025
3. Three IND applications for IMVT-1402 expected to be active by December 31, 2024
4. Cash position of $560 million as of June 30, 2024
5. R&D expenses increased to $75.5 million from $50.6 million YoY
6. Net loss of $87.2 million ($0.60 per share) compared to $73.9 million ($0.57 per share) YoY
The company aims to initiate 4-5 registrational programs for IMVT-1402 by March 2025 and clinical trials in 10 indications by March 2026.
Immunovant (Nasdaq: IMVT) reported corporate updates and financial results for the fourth quarter and fiscal year ended March 31, 2024.
The company plans to initiate 4-5 potentially registrational studies for its lead asset IMVT-1402 in various therapeutic areas by March 31, 2025. Topline data from the batoclimab Myasthenia Gravis study is expected in the same timeframe.
R&D expenses for Q4 increased to $66.1M, and net loss widened to $75.3M. For the fiscal year, R&D expenses rose to $212.9M, and net loss was $259.3M.
IMVT's cash position was approximately $635M as of March 31, 2024. They hold a new U.S. patent extending until June 2043.
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