iHub News
1月前
Immunovant Shares Rally on Positive Trial Results Despite Earnings Miss (IMVT)May 20, 2026 8:49 AM
IH Market News Immunovant, Inc. (NASDAQ:IMVT) reported a fourth-quarter loss of $0.73 per share on Wednesday, wider than the analyst consensus estimate of a $0.60 per share loss.Despite the weaker-than-expected earnings result, the company’s shares climbed 8.41% in pre-market trading as investors reacted positively to encouraging clinical data from Immunovant’s lead drug candidate, IMVT-1402. Rheumatoid Arthritis Trial Shows Strong Responses The company released preliminary results from its IMVT-1402 study in difficult-to-treat rheumatoid arthritis, reporting Week 16 response rates of 72.7% for ACR20, 54.5% for ACR50, and 35.8% for ACR70.The trial included 170 participants who had previously failed at least two advanced therapies. In a subgroup of patients who had failed both a JAK inhibitor and an anti-TNF inhibitor, response rates remained strong at 72.0%, 53.3%, and 37.4%, respectively.Immunovant said IMVT-1402 was generally safe and well tolerated, with no new drug-related safety concerns identified during the study. Additional Clinical Programs Remain on Track The company also announced that enrollment has been completed for its proof-of-concept study in cutaneous lupus erythematosus, with topline data expected during the second half of calendar year 2026.Management said development timelines for other IMVT-1402 programs continue as planned, including potentially registrational studies in Graves’ disease, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjögren’s disease. Expenses Rise as Development Accelerates Net loss for the fourth quarter widened to $147.9 million from $106.4 million in the same period last year.Research and development expenses increased to $142.3 million, compared with $93.7 million a year earlier, primarily due to ongoing IMVT-1402 clinical trial activity and $39.0 million in contractual costs tied to the discontinuation of batoclimab. Adjusted R&D expenses rose to $136.0 million from $87.2 million in the prior-year period.For the full fiscal year ended March 31, 2026, Immunovant reported a net loss of $505.6 million, or $2.77 per share, compared with a loss of $413.8 million, or $2.73 per share, in fiscal 2025. Cash Position Supports Future Launch Plans As of March 31, 2026, the company held $902.1 million in cash and cash equivalents. Immunovant said the balance is expected to fund operations through the potential commercial launch of IMVT-1402 in Graves’ disease.Immunovant stock price Original: Immunovant Shares Rally on Positive Trial Results Despite Earnings Miss (IMVT)
iHub News
5月前
Immunovant shares climb 7% as fiscal Q3 loss comes in better than expectedFebruary 6, 2026 10:50 AM
IH Market News
Immunovant, Inc. (NASDAQ:IMVT) reported fiscal third-quarter results on Friday that showed a smaller loss than analysts had forecast, lifting investor sentiment toward the clinical-stage immunology company.Shares jumped 7.40% in pre-market trading following the announcement.For the quarter ended December 31, 2025, Immunovant posted a loss of -$0.61 per share, beating consensus expectations of -$0.72 by $0.11. The net loss totaled $110.6 million, slightly narrower than the $111.1 million loss recorded in the same quarter last year. Research and development spending increased year over year to $98.9 million from $94.5 million, reflecting continued investment in the pipeline, while general and administrative expenses declined to $15.4 million from $19.8 million.The company ended the quarter with a strong liquidity position, reporting $994.5 million in cash as of December 31, 2025. This was supported by a financing round completed in December that included participation from key institutional investors and Roivant.Looking ahead, Immunovant expects topline data in the second half of 2026 from its IMVT-1402 study in rheumatoid arthritis as well as from a proof-of-concept trial in cutaneous lupus erythematosus. The company also plans to report results from Phase 3 trials of batoclimab in thyroid eye disease during the first half of 2026, with additional data from potentially registrational studies of IMVT-1402 in Graves’ disease and myasthenia gravis anticipated in 2027.Immunovant stock price
Original: Immunovant shares climb 7% as fiscal Q3 loss comes in better than expected
Fred Kadiddlehopper
7月前
CMO Michael Geffner steps down, effective immediately.
Michael Geffner, M.D., M.B.A., ceased serving as the Chief Medical Officer of Immunovant, Inc. (the “Company”), effective November 21, 2025 (“Separation Date”), in connection with the Company’s restructuring of its R&D leadership structure under the Company’s Chief Executive Officer, Eric Venker, M.D., PharmD.
The Company has entered into a Separation Agreement and General Release (“Separation Agreement”) with Dr. Geffner, pursuant to which Dr. Geffner will receive severance benefits in accordance with the existing terms of his employment agreement with the Company, dated January 9, 2024, which was filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on February 12, 2024 and as described in the Company’s Definitive Proxy Statement filed with the SEC on July 9, 2025. The Separation Agreement includes a standard release of claims in favor of the Company.
In addition, to support the transition of his responsibilities, the Separation Agreement provides that Dr. Geffner will provide certain consulting services to the Company through April 30, 2026 (the “Consulting Period”). Subject to Dr. Geffner’s continued service during the Consulting Period, Dr. Geffner’s outstanding equity awards will continue to vest in accordance with their terms and, in the event of a change in control of the Company during the Consulting Period, any then unvested equity awards that were scheduled to vest during the Consulting Period will immediately vest in full upon such change in control. The Separation Agreement also provides that the exercise period with respect to options that are vested as of the last day on which Dr. Geffner is providing consulting services to the Company will expire on the earlier of nine months following the last day of his consulting services and the original expiration date of the applicable options.
MiamiGent
3年前
I'm taking IMVT here @ $40.02 +3.839 (+10.61%)
Looking for a couple of gentlemanly dollars
As of Dec-21-20239:49:07 AM ET
https://stockcharts.com/h-sc/ui
The News
Autoimmune Disease Player Immunovant's Investigational Drug For Immune System Disorder Shows Response Rates Of Over 50%
BENZINGA
Immunovant Inc (IMVT.NaE) , on Thursday, released the results from the initial cohort of patients in an ongoing 24-week Phase 2 trial of batoclimab in patients with Graves' disease.
Graves' disease is an immune system disorder that results in the overproduction of thyroid hormones (hyperthyroidism).
The company says the results show that batoclimab meaningfully exceeded 50% response rates.
Consistent with studies of batoclimab in other indications, 680 mg administered subcutaneously (SC) in the initial cohort demonstrated an IgG reduction of up to 87%, with a mean IgG reduction of 81% after 12 weeks of treatment.
The 340 mg IgG reductions were lower. A similar dose response was observed for anti-TSHR autoantibodies, with deeper reductions observed following treatment with 680 mg of SC batoclimab compared to 340 mg of SC batoclimab.
In addition, numerically higher responses were observed following treatment with 680 mg of batoclimab across a range of clinical parameters compared to treatment with 340 mg of batoclimab.
Batoclimab was generally well tolerated, with no new safety signals observed in the initial data set.
subslover
3年前
Immunovant Announces Positive Initial IMVT-1402 Phase 1 SAD and 300 mg Subcutaneous MAD Results
IMVT-1402 subcutaneous (SC) doses achieved peak Immunoglobulin G (IgG) reductions that are similar to those previously observed with batoclimab
No decrease in serum albumin below baseline or increase in low-density lipoprotein cholesterol (LDL-C) above baseline was observed after 4 weeks of dosing in the 300 mg multiple-ascending dose (MAD) SC cohort
IMVT-1402 is being developed as a simple SC injection
NEW YORK, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that subcutaneously administered doses of IMVT-1402 produced dose-dependent reductions in IgG in initial data from a Phase 1 clinical trial in healthy adults, with no dose-related changes in serum albumin or LDL-C, bolstering IMVT-1402 as a potential best-in-class neonatal fragment crystallizable receptor (FcRn) inhibitor.
“We are encouraged by the strong pharmacodynamic data observed to date with IMVT-1402,” said Pete Salzmann, M.D., chief executive officer of Immunovant. “These first-in-human results are consistent with those observed in prior non-human primate studies, and we look forward to sharing additional MAD data in November.”
This Phase 1 clinical trial is a randomized, double-blind, placebo-controlled ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMVT-1402 in healthy adults.
In the single-ascending dose (SAD) portion of the study, subcutaneously administered IMVT-1402 demonstrated a consistent reduction in IgG with potency that was similar to or greater than that of batoclimab. The safety data were generally favorable, with all adverse events (AEs) mild or moderate, and no significant reduction from baseline in serum albumin or increase in LDL-C observed at any timepoint measured (all p>0.05).
Immunovant is also pleased to announce that initial MAD study results for the 300 mg cohort were released ahead of schedule today. These data represent all the MAD data currently available. Dosing for the 600 mg cohort has recently begun. After four weekly 300 mg SC doses of IMVT-1402, the mean total IgG reduction from baseline in this MAD cohort was 63%, with no decrease in serum albumin below baseline and no increase in LDL-C above baseline observed. Treatment-emergent adverse events were observed to be mild or moderate in severity. IMVT-1402 was delivered subcutaneously in seconds to participants in this cohort as a simple 2 mL injection at a concentration of 150 mg/mL.
Conference Call & Webcast:
Immunovant will host a conference call with accompanying slides and a simultaneous webcast today, September 26, 2023 at 8:00 a.m. EDT to discuss the initial single-ascending dose and multiple-ascending dose data. To participate in the conference call, please register in advance here. To access the live and archived webcast, please visit Immunovant’s website at https://www.immunovant.com/investors/news-events. The archived webcast will be available for a limited time on the Company’s website.
About IMVT-1402
IMVT-1402 is designed to be a potentially best-in-class anti-FcRn antibody for the treatment of IgG-mediated autoimmune diseases. In the initial results of a Phase 1 clinical trial in healthy volunteers, IMVT-1402 demonstrated favorable pharmacodynamic and safety data. These attributes, combined with a convenient route of administration that may enable patient self-administration, position IMVT-1402 well as a potential treatment for a variety of autoimmune diseases associated with patient unmet need.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit www.immunovant.com.
crudeoil24
5年前
Immunovant, Inc., formerly Health Sciences Acquisitions Corp, is a clinical-stage biopharmaceutical company. The Company is focused on developing treatments for patients with autoimmune diseases. It is developing IMVT-1401, a human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. IMVT-1401 is being developed to target the neonatal Fc receptor (FcRn).
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