Immunovant(IMVT)

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Immunovant: Continued FcRn Targeting With IMVT-1402 Pivotal Study
Seeking Alpha· 2024-12-27 15:50
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...
Immunovant's Q2 Loss Wider Than Expected, Pipeline in Focus
ZACKS· 2024-11-08 16:41
Core Viewpoint - Immunovant, Inc. reported a wider net loss for Q2 fiscal 2025 than expected, with no approved products and no revenue generation [1] Financial Performance - The net loss for Q2 fiscal 2025 was 74 cents per share, exceeding the Zacks Consensus Estimate of a loss of 61 cents and wider than the previous year's loss of 45 cents per share [1] - Research and development (R&D) expenses reached $97.3 million, a 103% increase from the same quarter last year, driven by preparations for future clinical studies and increased personnel-related expenses [2] - General and administrative expenses were $18.5 million, up 33% year-over-year, primarily due to higher personnel-related expenses and legal fees [3] - As of September 30, 2024, the cash balance was $472.9 million, down from $560 million as of June 30, 2023 [3] Pipeline Developments - Immunovant is focusing on IMVT-1402, a next-generation FcRn inhibitor, as its lead asset, with plans to initiate four to five registrational programs over the next fiscal year [4][5] - The company aims to start studies in a total of 10 indications for IMVT-1402 over the next two fiscal years, leveraging existing data from batoclimab studies for financial efficiencies [5] - Late-stage studies for IMVT-1402 will include indications such as Graves' disease, Myasthenia Gravis, and Chronic Inflammatory Demyelinating Polyneuropathy [6] - Immunovant is also evaluating batoclimab in ongoing mid-late-stage studies for various autoimmune indications [7] Upcoming Milestones - Positive data from a mid-stage study on batoclimab for Graves' disease was announced, with plans to initiate a pivotal study for IMVT-1402 by the end of 2024 [8] - Top-line results from the Myasthenia Gravis study of batoclimab are expected by the end of the fiscal year on March 31, 2025 [8] - The company may transition its batoclimab CIDP study to a registrational program with IMVT-1402, with top-line data from the phase IIb study expected by March 31, 2025 [9] - Top-line data from the late-stage thyroid eye disease study of batoclimab is scheduled for the second half of 2025 [10]
Immunovant(IMVT) - 2025 Q2 - Quarterly Report
2024-11-07 11:49
Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered Common Stock, $0.0001 par value per share IMVT The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission Fil ...
Immunovant(IMVT) - 2025 Q2 - Quarterly Results
2024-11-07 11:42
Exhibit 99.1 Immunovant Provides Development Updates and Reports Financial Results for the Quarter Ended September 30, 2024 • Five Investigational New Drug (IND) applications cleared across a range of therapeutic areas and FDA divisions for lead asset, IMVT-1402 • Proof of concept data from batoclimab trial in Graves' disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiatio ...
Immunovant Provides Development Updates and Reports Financial Results for the Quarter Ended September 30, 2024
GlobeNewswire News Room· 2024-11-07 11:30
Five Investigational New Drug (IND) applications cleared across a range of therapeutic areas and FDA divisions for lead asset, IMVT-1402Proof of concept data from batoclimab trial in Graves’ disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year endIND cleared for IMVT-1402 in rheumatoid art ...
What's Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday?
Benzinga· 2024-09-09 16:54
Monday, Immunovant, Inc. IMVT reported results from the Phase 2a trial of batoclimab in Graves' Disease, an immune system condition that affects the thyroid gland. It causes the body to make too much thyroid hormone. Immunovant is a member of the Roivant Sciences Ltd. ROIV family of companies. Also Read: Vivek Ramaswamy-Founded Roivant's Anti-Inflammatory Drug Aces Mid-Stage Study. As previously disclosed, the batoclimab phase 2a trial in uncontrolled Graves' Disease enrolled patients who were hyperthyroid ...
IMVT Stock Up on Upbeat Data From Graves' Disease Study of Batoclimab
ZACKS· 2024-09-09 13:35
Shares of Immunovant (IMVT) are rising in the pre-market hours on Sept. 9 after the company announced positive data from the mid-stage study of its investigational candidate, batoclimab, which is being developed for Graves' Disease (GD). IMVT's Batoclimab Shows Superior Efficacy in GD Patients The enrolled patient population of the phase IIa study of batoclimab comprised uncontrolled GD patients who were hyperthyroid despite anti-thyroid drugs (ATD) therapy. Patients were then treated with the high batoclim ...
Top 2 Health Care Stocks That May Collapse This Quarter
Benzinga· 2024-09-09 13:12
As of Sept. 9, 2024, two stocks in the health care sector could be flashing a real warning to investors who value momentum as a key criteria in their trading decisions. The RSI is a momentum indicator, which compares a stock's strength on days when prices go up to its strength on days when prices go down. When compared to a stock's price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered overbought when the RSI is above 70, according to ...
Immunovant Provides Update on Graves' Disease Development Program
GlobeNewswire News Room· 2024-09-09 07:55
High dose batoclimab achieved 76% response rate in patients uncontrolled on antithyroid drugs (ATDs) at week 12 High dose batoclimab achieved 56% ATD-Free response rate in patients uncontrolled on ATDs at week 12 Strong correlation observed between degree of IgG lowering and clinical outcomes yields potential bestin-class and first-in-class opportunity for IMVT-1402 in Graves' Disease (GD) Real world claims data indicates 25-30% of Graves' Disease patients per year are uncontrolled on ATDs with minimal to n ...
Why Is Immunovant (IMVT) Up 13.8% Since Last Earnings Report?
ZACKS· 2024-09-05 16:36
It has been about a month since the last earnings report for Immunovant, Inc. (IMVT) . Shares have added about 13.8% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Immunovant due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Immunovant's Q1 Earnings Miss Estimates ...