Immunovant Inc Stock Price, News & Analysis

Immunovant (IMVT) has announced positive results from its clinical trials for batoclimab in two autoimmune conditions. The Phase 3 study in Myasthenia Gravis (MG) achieved its primary endpoint, demonstrating 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).

In the Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 2b study's Period 1, patients showed a mean improvement of 1.8 in adjusted INCAT disability scores. 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 has active INDs for both conditions and plans to initiate pivotal studies for their lead asset IMVT-1402 in these indications.

Immunovant (Nasdaq: IMVT) has announced an upcoming investor webcast scheduled for Wednesday, March 19, 2025, at 8:00 AM ET. The presentation will focus on revealing results from two significant clinical trials: the Phase 3 study of batoclimab in Myasthenia Gravis (MG) and initial findings from the Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

The webcast will feature presentations from Pete Salzmann, M.D., MBA, Immunovant's Chief Executive Officer, alongside Matt Gline, Chief Executive Officer of Roivant. Interested participants can access the live webcast through registration, and it will also be available in the News & Events section of Immunovant's website. A replay option will be provided immediately after the event.

Immunovant (NASDAQ: IMVT) reported financial results for Q3 2024, highlighting significant progress in its clinical programs. The company has received clearance for six IND applications and initiated pivotal studies for IMVT-1402 in Graves' disease and difficult-to-treat rheumatoid arthritis using a 2.25ml autoinjector.

Key financial metrics include a pro forma cash balance of approximately $825 million as of December 31, 2024, including $450 million from a recent private placement. Q3 net loss increased to $111.1 million ($0.76 per share) compared to $51.4 million ($0.36 per share) in the previous year. R&D expenses rose to $94.5 million from $48.3 million year-over-year.

The company expects to release top-line results from the batoclimab trial in myasthenia gravis and initial results from the CIDP trial by March 31, 2025, with additional Graves' disease data expected in summer 2025.

Immunovant (Nasdaq: IMVT), a clinical-stage immunology company, announced a $450 million private placement. The company will sell 22,500,000 shares of common stock at $20.00 per share to three institutional accredited investors in a private investment in public equity (PIPE). The transaction is expected to close around January 15, 2025, subject to customary conditions.

The proceeds will be used to advance Immunovant's development pipeline, working capital, and other corporate purposes. Dr. Pete Salzmann, CEO of Immunovant, stated that the additional capital will support the development of their lead asset, IMVT-1402.

The shares sold in the PIPE are not registered under the Securities Act of 1933 and cannot be offered or sold in the U.S. without an exemption. However, Immunovant has agreed to register the resale of these shares with the SEC.

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.