IMVT - Earnings announcements

IMVT-1402 showed clinically meaningful response rates of 72.7% ACR20, 54.5% ACR50 and 35.8% ACR70 at Week 16 in the open label period of its trial in difficult-to-treat rheumatoid arthritis (D2T RA); Immunovant will provide further updates on this program in the second half of calendar year 2026IMVT-1402 proof-of-concept trial in cutaneous lupus erythematosus (CLE) fully enrolled with topline data expected in the second half of calendar year 2026All other clinical development timelines remain on track for IMVT-1402, including potentially registrational studies in Graves' disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren's disease (SjD)

DURHAM, N.C., May 11, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT) today announced that it will report its financial results for the fourth quarter and fiscal year ended March 31, 2026, and provide a business update at 8:00 a.m. ET on Wednesday, May 20, 2026. To access the Roivant (NASDAQ:ROIV) conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "News & Events" in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant's website after the conference call. About Immunovant  Immunova

Phase 3 studies of batoclimab in thyroid eye disease (TED) each failed to meet their primary endpoint; safety results were consistent with previous findingsPatients in the TED studies demonstrated greater levels of proptosis improvement from baseline after the initial 12-week high-dose period than after the following 12-week low-dose period, supporting the benefit of deeper IgG suppression. The hyperthyroid patients in the TED studies showed similar response rates of thyroid hormone normalization to those seen in the batoclimab Phase 2 study in Graves' diseaseImmunovant remains focused on rapid advancement of IMVT-1402 in multiple indications DURHAM, N.C., April 02, 2026 (GLOBE NEWSWIRE)

IMVT-1402 potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA) fully enrolled, with topline data expected in the second half of calendar year 2026; topline data from the proof-of-concept trial in cutaneous lupus erythematosus (CLE) expected in the second half of calendar year 2026IMVT-1402 development is progressing with potentially registrational studies in Graves' disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren's disease (SjD) remaining on trackUnderwritten financing with key institutional investors and Roivant generated approximately $550 million in gross proceeds, extending Immunovant's cash runway

DURHAM, N.C. and NEW YORK, Jan. 23, 2026 (GLOBE NEWSWIRE) -- Immunovant (NASDAQ:IMVT) today announced that it will report its financial results for the third quarter ended December 31, 2025, and provide a business update at 8:00 a.m. ET on Friday, February 6, 2026. To access the Roivant (NASDAQ:ROIV) conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "News & Events" in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant's website after the conference call. About ImmunovantImmunovant,

Study in uncontrolled Graves' disease (GD) patients treated for 24 weeks showed first-ever potentially disease-modifying outcome with six-month off-treatment dataIMVT-1402 development is progressing with potentially registrational studies in GD, myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA) and Sjögren's disease (SjD) remains on trackImmunovant remains on track for the first of the two batoclimab Phase 3 thyroid eye disease (TED) studies to read out before the end of calendar year 2025. However, due to evolving competitive dynamics, the Company anticipates sharing topline results from both TED studies concur

NEW YORK, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Immunovant (NASDAQ:IMVT) today announced that it will report its financial results for the second quarter ended September 30, 2025, and provide a business update at 8:00 a.m. ET on Monday, November 10, 2025. To access the Roivant (NASDAQ:ROIV) conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "News & Events" in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant's website after the conference call. About Immunovant Immunovant, Inc. is a cl

First-ever potentially disease-modifying therapy for uncontrolled Graves' disease patientsOf 21 patients who entered the six-month off-treatment follow-up period, ~80% (17/21) demonstrated response, resulting in normal thyroid function (T3 and T4 less than the upper limit of normal) at the end of the six-month follow-up periodOf the 17 responders to therapy, ~50% (8/17) achieved anti-thyroid drug (ATD) free remission at six months following end of batoclimab treatmentTwo potentially registrational trials for IMVT-1402 in Graves' disease are currently enrolling with topline readouts expected in 2027Roivant to host investor call to discuss these updates today, September 3, 2025, at 4:30 p.m. E

First-ever potentially disease-modifying therapy for uncontrolled Graves' disease patientsOf 21 patients who entered the six-month off-treatment follow-up period, ~80% (17/21) demonstrated response, resulting in normal thyroid function (T3 and T4 less than the upper limit of normal) at the end of the six-month follow-up periodOf the 17 responders to therapy, ~50% (8/17) achieved anti-thyroid drug (ATD) free remission at six months following end of batoclimab treatmentTwo potentially registrational trials for IMVT-1402 in Graves' disease are currently enrolling with topline readouts expected in 2027Roivant to host investor call to discuss these updates today, September 3, 2025, at 4:30 p.m. E

Initiated a second potentially registrational study of IMVT-1402 in Graves' disease (GD) and a potentially registrational study of IMVT-1402 in Sjögren's disease (SjD), both in June 2025All other clinical trials in previously announced six-indications remain on track with increased focus on clinical executionRemission data from the batoclimab proof-of-concept study in GD to be reported at the American Thyroid Association (ATA) Annual Meeting in September 2025Current cash balance provides runway for announced indications through GD readout expected in 2027 NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage immunology company dedicated to enabling n

Immunovant's new management team is focused on rapid clinical execution for the six announced indications for IMVT-1402, including a second potentially registrational study in Graves' disease (GD) and a potentially registrational study in Sjögren's disease (SjD), both expected to start in summer 2025Positive data from first-generation batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) demonstrated that deeper IgG reductions correlated with improved clinical outcomes across a range of assessments and timepoints suggesting a potential best-in-class efficacy profile for IMVT-1402Current cash balance provides runway for announced indications

NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that it will host an investor webcast on Wednesday, March 19th at 8:00 a.m. ET to review results from its Phase 3 study of batoclimab in MG and initial results from its Phase 2b study in CIDP. Pete Salzmann, M.D., MBA, Chief Executive Officer of Immunovant, will be joined by Matt Gline, Chief Executive Officer of Roivant, for the call. Webcast DetailsThe company will host a webcast at 8:00 a.m. ET on Wednesday, March 19. Please click here to register for the event. The live webcast

Lead asset IMVT-1402 rapidly progressing with now six Investigational New Drug (IND) applications cleared and pivotal studies in Graves' disease (GD) and difficult-to-treat rheumatoid arthritis (D2T RA) now enrolling with 2.25ml autoinjector Additional results from batoclimab proof-of-concept study in GD, including 6-month treatment free remission data expected in summer 2025 Top line results of the batoclimab trial in myasthenia gravis (MG) and initial results from period 1 of batoclimab trial in chronic inflammatory demyelinating polyneuropathy (CIDP) expected by March 31, 2025 Pro forma cash balance of approximately $825 million as of December 31, 2024, including approximately $450 mil

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 arthritis (RA), with potential best-in-class profile in difficult-to-treat (D2T) RA; initiation of potentially registrational trial to evaluate IMVT-1402 in D2T RA expected by March 31, 2025O

Completed enrollment in batoclimab pivotal Myasthenia Gravis (MG) trial; top-line results and initiation of a potentially registrational program for IMVT-1402 on track for fiscal year end (March 31, 2025) Progressed development of lead asset IMVT-1402 with 3 Investigational New Drug (IND) applications expected to be active by calendar year end (December 31, 2024)Progressed Graves' disease (GD) program and on track to disclose additional results from the batoclimab study in GD as well as an overview of our development program for IMVT-1402 in GD in the fall of 2024As of June 30, 2024, Immunovant's cash and cash equivalents totaled approximately $560 million NEW YORK, Aug. 06, 2024 (GLOB

Following a recently completed Type B meeting with the FDA, Immunovant is on track to initiate 4 to 5 potentially registrational studies for its lead asset IMVT-1402 in endocrinology, neurology, and other therapeutic areas over this fiscal year ending March 31, 2025Topline data from the batoclimab Myasthenia Gravis (MG) study is also expected over this fiscal year and further potentially registrational development in MG with IMVT-1402 is expected to begin in the same timeframeImmunovant has decided to run the batoclimab trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) longer prior to unblinding period 1 in order to better ensure that the data from the batoclimab trial, combi

Immunovant plans to initiate 4-5 potentially registrational programs for IMVT-1402 over the next fiscal year Immunovant plans to initiate trials in 10 indications for IMVT-1402 over the next two fiscal yearsInitial period 1 data from Phase 2b clinical trial of batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) expected in the second or third quarter of calendar year 2024Global Phase 3 clinical trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) progressing and on track for expected top-line data in the second half of calendar year 2024 (MG) and the first half of calendar year 2025 (TED) NEW YORK, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Immunovant, In

Results from the 600 mg MAD cohort for IMVT-1402 similar to previously disclosed results from the 300 mg MAD cohort for IMVT-1402IMVT-1402 was observed to deliver dose dependent and deep IgG reductions similar to batoclimab in its Phase 1 studyIMVT-1402 600 mg was observed to deliver placebo-like impact on albumin and low-density lipoprotein cholesterol (LDL-C), similar to the previously disclosed 300 mg MAD cohort dataPotential best-in-class profile enables broad and exciting portfolio of indications, taking advantage of IgG reduction we expect will reach 80% with continued weekly dosing of 600 mg delivered by simple subcutaneous injection NEW YORK, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Immu

Results from the 600 mg MAD cohort for IMVT-1402 similar to previously disclosed results from the 300 mg MAD cohort for IMVT-1402IMVT-1402 was observed to deliver dose dependent and deep IgG reductions similar to batoclimab in its Phase 1 studyIMVT-1402 600 mg was observed to deliver placebo-like impact on albumin and low-density lipoprotein cholesterol (LDL-C), similar to the previously disclosed 300 mg MAD cohort dataPotential best-in-class profile enables broad and exciting portfolio of indications, taking advantage of IgG reduction we expect will reach 80% with continued weekly dosing of 600 mg delivered by simple subcutaneous injection NEW YORK, Nov. 28, 2023 (GLOBE NEWSWIRE) --  Imm

IMVT-1402 subcutaneous (SC) doses achieved peak Immunoglobulin G (IgG) reductions that are similar to those previously observed with batoclimabNo 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 cohortIMVT-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 I

IMVT-1402 subcutaneous (SC) doses achieved peak Immunoglobulin G (IgG) reductions that are similar to those previously observed with batoclimabNo 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 cohortIMVT-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

NEW YORK, Sept. 25, 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 it will report initial IMVT-1402 Phase 1 results on Tuesday, September 26, 2023. Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET to discuss the results. 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

Initial data from the Phase 1 clinical trial of IMVT-1402 on track for September 2023 (single-ascending dose) and October/November 2023 (multiple-ascending dose) Phase 2 proof-of-concept data for batoclimab in Graves' disease (GD) expected in the fourth quarter of 2023Global clinical trials of batoclimab are ongoing in myasthenia gravis (MG), thyroid eye disease (TED), and chronic inflammatory demyelinating polyneuropathy (CIDP) NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its fiscal first qua

Investigational New Drug (IND) application and Clinical Trial Application (CTA) for IMVT-1402 cleared by the FDA and MEDSAFE, respectivelyPhase 1 clinical trial in healthy subjects initiated in New ZealandPhase 2 proof-of-concept clinical trial of batoclimab in Graves' disease (GD) initiated in GermanyGlobal clinical trials of batoclimab are ongoing in myasthenia gravis (MG), thyroid eye disease (TED), and chronic inflammatory demyelinating polyneuropathy (CIDP) NEW YORK, May 22, 2023 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial

A Phase 1 clinical trial of IMVT-1402 is on track to be initiated in early calendar year 2023A Phase 3 clinical trial of batoclimab in thyroid eye disease (TED) and a Phase 2b clinical trial in chronic inflammatory demyelinating polyneuropathy (CIDP) were initiated, as expectedPhase 3 clinical trial of batoclimab in myasthenia gravis (MG) is ongoing Cash balance of approximately $433 million as of December 31, 2022 NEW YORK, Feb. 03, 2023 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company committed to enabling normal lives for people with autoimmune diseases, today reported recent company updates and financial results for its fiscal third quarte

IMVT-1402, a next generation, subcutaneously administered, neonatal fragment crystallizable receptor (FcRn) inhibitor unveiledNew development programs for batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) and Graves' disease announcedPhase 3 trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) progressing Pro forma cash balance of $476 million expected to extend cash runway into second half of calendar year 2025 NEW YORK, Nov. 04, 2022 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company committed to enabling normal lives for people with autoimmune diseases, today reported recent company updates and fin

NEW YORK, Aug. 05, 2022 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today reported recent company updates and financial results for its fiscal first quarter ended June 30, 2022. Recent Updates and Anticipated Milestones: Immunovant initiated a pivotal clinical trial of batoclimab in Myasthenia Gravis in June 2022. Top-line data from the trial are expected in the second half of calendar year 2024. For its program in Thyroid Eye Disease, Immunovant achieved alignment with the United States Food and Drug Administration (FDA) Division of Ophthalmology on plans for two plac

Immunovant plans to initiate two placebo-controlled Phase 3 clinical trials of batoclimab in thyroid eye disease (TED) in the second half of calendar year 2022 with top-line data expected for both in the first half of calendar year 2025Immunovant estimates annual addressable U.S. TED population for a new mechanism of action to be 8,000-18,000 patientsImmunovant on track to initiate pivotal Phase 3 clinical trial of batoclimab in myasthenia gravis (MG), by the end of June 2022Cash balance of $494 million as of March 31, 2022 expected to provide cash runway into calendar year 2025 NEW YORK, June 08, 2022 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceuti

NEW YORK, June 06, 2022 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today announced that it will report its fourth quarter and full-year 2022 financial results before the open of the U.S. financial markets on Wednesday, June 8, 2022. The company also plans to host a webcast and conference call on Wednesday, June 8, 2022 at 8:00 AM ET. Following prepared remarks, the call will include a live question-and-answer session for the investment community. To access the webcast and the presentation being shared on the call, please visit Immunovant's website at https://www.immu

NEW YORK, Feb. 04, 2022 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today reported financial results for its fiscal first quarter ended December 31, 2021. Immunovant ended the quarter with approximately $527.0 million in cash. Financial Highlights for Fiscal Third Quarter Ended December 31, 2021: R&D Expenses: Research and development expenses were $29.8 million for the three months ended December 31, 2021, compared to $21.1 million for the three months ended December 31, 2020. The year-over-year increase primarily reflected higher costs related to cross-indication cli

NEW YORK, Dec. 30, 2021 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, announced that the Company achieved alignment with the FDA Division of Neurology 1 ("FDA") to move forward in myasthenia gravis ("MG"). Immunovant plans to start its Phase 3 study for batoclimab in MG in the first half of calendar year 2022. The trial will include an induction (primary efficacy) period during which Immunovant plans to study doses of 680mg and 340mg of batoclimab delivered weekly by subcutaneous injection. The primary efficacy analysis will be based on MG-ADL measured in Acetylcholine Re

NEW YORK, Nov. 05, 2021 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today reported financial results for its fiscal first quarter ended September 30, 2021. Immunovant ended the quarter with approximately $559 million in cash. Financial Highlights for Fiscal Second Quarter Ended September 30, 2021: R&D Expenses: Research and development expenses were $21.4 million for the three months ended September 30, 2021, compared to $12.0 million for the three months ended September 30, 2020. The year-over-year increase primarily reflected higher contract manufacturing costs a

NEW YORK, Aug. 06, 2021 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today announced that it will host a conference call and audio webcast on Monday, August 9, 2021 at 8 a.m. ET to discuss financial results for its fiscal first quarter ended June 30, 2021. Following prepared remarks, the call will include a live question-and-answer session for the investment community. To access the webcast, please visit Immunovant's website at www.immunovant.com. Participants may also dial in using the numbers provided below: Toll Free: 1-877-407-9039Toll/International: 1-201-689-8470

Immunovant plans to resume clinical development of IMVT-1401 in Myasthenia Gravis (MG) and Warm Autoimmune Hemolytic Anemia (WAIHA) as well as initiate two additional mid-to-late stage studies in the next yearProgram-wide data review suggests that IMVT-1401 has a broader therapeutic window than previously anticipated and that lipid elevations are predictable, manageable, and appear to be driven by reductions in albuminCash balance of approximately $400 million as of March 31, 2021 NEW YORK, June 01, 2021 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today provided a corpo

NEW YORK, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today reported financial results for its fiscal third quarter and nine months ended December 31, 2020.  Immunovant ended the quarter with approximately $422 million in cash. In February 2021, we voluntarily paused dosing in our clinical trials for IMVT-1401 due to elevated total cholesterol and LDL levels observed in patients treated with IMVT-1401. We have informed our regulators and investigators of this voluntary pause of dosing in ASCEND GO-2, a Phase 2b trial in Thyroid Eye Disease and ASCEND-WA