Immunovant Provides Corporate Updates and Reports Financial Results for the Quarter Ended September 30, 2026
The higher rheumatoid arthritis dose met its primary endpoint, while further Sjögren’s development is considered unlikely.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Immunovant (IMVT) reported that IMVT-1402 600 mg met the primary endpoint in its difficult-to-treat rheumatoid arthritis trial and released quarterly results. At Week 28, ACR20 response, a measure of joint-symptom improvement, was 92.5% versus 75.6% with placebo (p=0.0139). This randomized withdrawal period included responders to an open-label lead-in. The 300 mg dose did not differ from placebo; secondary disease-activity endpoints numerically favored 600 mg.
Immunovant plans FDA discussions later in 2026 and expects further Sjögren’s development beyond the ongoing Phase 2 trial is unlikely. It expects Graves’ disease and myasthenia gravis data in 2027, and chronic inflammatory demyelinating polyneuropathy data in 2028. Quarterly net loss narrowed to $97.2 million from $126.5 million a year earlier. Cash was $722.3 million; the company expects runway to a potential Graves’ disease launch under its current operating plan.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointIMVT-1402 600 mg achieved 92.5% ACR20 response versus 75.6% placebo at Week 28 (p=0.0139).
- Moderate point. Forward-looking: it has not happened yet and may not happen.Immunovant expects potentially registrational Graves’ disease and myasthenia gravis topline data in calendar 2027.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Immunovant expects potentially registrational chronic inflammatory demyelinating polyneuropathy topline data in calendar 2028.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Immunovant expects $722.3 million cash to fund operations to a potential Graves’ disease launch under its current plan.
- Moderate pointQuarterly net loss narrowed to $97.2 million, or $0.47 per share, versus $126.5 million, or $0.73, a year earlier.
6 minor points
- Minor pointExploratory Week 28 ACR50 responses were 80.0% versus 56.1% placebo for 600 mg (nominal p=0.0117).
- Minor pointExploratory Week 28 ACR70 responses were 52.5% versus 36.6% placebo for 600 mg (nominal p=0.1674).
- Minor pointPeriod 2 recorded no serious adverse events, Grade 3-or-higher treatment-emergent events, or adverse-event discontinuations in any arm.
- Minor point. Forward-looking: it has not happened yet and may not happen.Immunovant plans FDA discussions later in 2026 on the rheumatoid arthritis registrational path.
- Minor pointQuarterly research and development expenses fell to $85.0 million from $114.2 million a year earlier.
- Minor pointSix-month general and administrative expenses fell to $36.8 million from $43.5 million a year earlier.
Negative
- Moderate point. Forward-looking: it has not happened yet and may not happen.Immunovant expects further Sjögren’s development is unlikely beyond the ongoing, fully enrolled Phase 2 trial.
- Moderate pointCash and equivalents declined to $722.3 million at September 30, 2026, from $902.1 million at March 31, 2026.
- Minor pointIMVT-1402 300 mg showed no difference from placebo: 75.0% ACR20 response at Week 28 (p=0.9426).
- Minor pointSecondary CDAI changes were -0.3 for 600 mg versus +3.1 placebo from Period 2 baseline (p=0.1096).
- Minor pointSecondary SDAI changes were +0.1 for 600 mg versus +3.5 placebo from Period 2 baseline (p=0.1299).
5 minor points
- Minor pointExploratory ACR50 and ACR70 analyses were not powered to detect differences.
- Minor pointSix-month net loss widened to $250.5 million versus $247.1 million; loss per share narrowed to $1.22 versus $1.43.
- Minor pointSix-month research and development expenses rose to $227.6 million from $215.4 million a year earlier.
- Minor pointQuarterly general and administrative expenses rose to $19.1 million from $17.5 million a year earlier.
- Minor pointCommon shares outstanding increased to 206,785,540 at September 30, 2026, from 203,940,353 at March 31, 2026.
News Explained
Immunovant reported 206,785,540 common shares outstanding at
Key Figures
- ACR20 response, 600 mg
- 92.5% vs. 75.6% placebo; p=0.0139
- D2T RA Period 2, Week 28; primary endpoint
- ACR20 response, 300 mg
- 75.0%; p=0.9426
- D2T RA Period 2, Week 28; no difference from placebo reported
- ACR50 response
- 80.0% vs. 56.1% placebo; nominal p=0.0117
- Exploratory analysis, Week 28; trial not powered to detect differences
- ACR70 response
- 52.5% vs. 36.6% placebo; nominal p=0.1674
- Exploratory analysis, Week 28; trial not powered to detect differences
- Cash and cash equivalents
- $722.3 million
- As of September 30, 2026
- Net loss
- $97.2 million ($0.47 per common share) vs. $126.5 million ($0.73 per common share)
- Three months ended September 30, 2026 vs. September 30, 2025
Key Terms
acr20 medical
randomized withdrawal design technical
fda regulatory
non-gaap financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
- IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28 (
92.5% vs.75.6% placebo, p=0.0139) in Period 2 (randomized withdrawal design following open-label lead-in) of the potentially registrational trial in patients with difficult-to-treat rheumatoid arthritis (D2T RA) - In exploratory analyses, ACR50 and ACR70 response rates for patients who remained on IMVT-1402 600 mg in Period 2 continued to increase, reaching
80.0% ACR50 and52.5% ACR70 at Week 28 - FDA discussions planned for later this year to determine the path forward regarding the registrational program for IMVT-1402 in D2T RA
- In light of the evolving Sjögren’s disease (SjD) landscape and recent data in the field, we expect it is unlikely that we will advance IMVT-1402 further in SjD beyond the ongoing, fully enrolled Phase 2 trial
- All other clinical development timelines remain on track
- Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 9, 2026
DURHAM, N.C., Nov. 09, 2026 (GLOBE NEWSWIRE) -- Immunovant (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 second fiscal quarter ended September 30, 2026.
Recent Highlights and Upcoming Milestones:
Following the open-label lead-in in Period 1 of the potentially registrational trial in patients with D2T RA, where a total of 170 participants were enrolled to receive IMVT-1402 600 mg for 16 weeks, study participants meeting the criteria for an ACR20 response at Weeks 14 and 16 were eligible to advance to Period 2 of the trial. A total of 117 participants were included in the Period 2 efficacy analysis and randomized to IMVT-1402 600 mg (n=40), IMVT-1402 300 mg (n=36), or placebo (n=41). IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28 (
In light of the evolving SjD landscape and recent data in the field, we expect it is unlikely that we will advance IMVT-1402 further in SjD beyond the ongoing, fully enrolled Phase 2 trial.
The Company expects to report topline data across potentially registrational trials of IMVT-1402 in Graves’ disease (GD) and myasthenia gravis (MG) in calendar year 2027. In calendar year 2028, topline data are expected for the potentially registrational trial of IMVT-1402 in chronic inflammatory demyelinating polyneuropathy (CIDP).
Financial Highlights for Fiscal Second Quarter Ended September 30, 2026:
Cash Position: As of September 30, 2026, Immunovant’s cash and cash equivalents totaled
Research and Development Expenses: Research and development (R&D) expenses were
Non-GAAP R&D expenses were
General and Administrative Expenses: General and administrative (G&A) expenses were
Non-GAAP G&A expenses were
Net Loss: Net loss was
Common Stock: As of September 30, 2026, there were 206,785,540 shares of common stock issued and outstanding.
Financial Highlights for Fiscal Six Months Ended September 30, 2026:
Research and Development Expenses: Research and development expenses were
Non-GAAP R&D expenses were
General and Administrative Expenses: General and administrative expenses were
Non-GAAP G&A expenses were
Net Loss: Net loss was
Non-GAAP Financial Measures: In addition to reporting the financial results in accordance with accounting principles generally accepted in the United States of America (GAAP), Immunovant reports certain financial results that differ from what is reported under GAAP. Immunovant believes these non-GAAP financial measures are useful to investors and others because they allow for additional information with respect to financial measures used by management in its financial and operational decision-making and they may be used by institutional investors and the analyst community to help them analyze the health of Immunovant’s business. However, there are a number of limitations related to the use of non-GAAP financial measures, and these non-GAAP measures should be considered in addition to, not as a substitute for or in isolation from, Immunovant’s financial results prepared in accordance with GAAP. Other companies, including companies in Immunovant’s industry, may calculate these non-GAAP financial measures differently or not at all, which reduces their usefulness as comparative measures.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). 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 immunovant.com.
Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 9, 2026.
To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” 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.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant’s progress towards developing IMVT-1402 across a broad range of indications; Immunovant’s expectations regarding the availability of results of clinical trials of IMVT-1402 and whether those results may be adequate to support registration; and the Company’s beliefs regarding the potential sufficiency of its cash runway. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive of final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, regulatory strategy, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402; Immunovant is at various stages of clinical development for IMVT-1402; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 20, 2026, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
| IMMUNOVANT, INC. Condensed Consolidated Statements of Operations (Unaudited, in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended September 30, | Six Months Ended September 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 85,011 | $ | 114,249 | $ | 227,642 | $ | 215,449 | |||||||
| General and administrative | 19,144 | 17,513 | 36,836 | 43,537 | |||||||||||
| Total operating expenses | 104,155 | 131,762 | 264,478 | 258,986 | |||||||||||
| Interest income, net | (6,897 | ) | (5,604 | ) | (13,992 | ) | (11,941 | ) | |||||||
| Other income, net | (12 | ) | (250 | ) | (16 | ) | (1,437 | ) | |||||||
| Loss before provision for income taxes | (97,246 | ) | (125,908 | ) | (250,470 | ) | (245,608 | ) | |||||||
| Provision for income taxes | — | 594 | — | 1,507 | |||||||||||
| Net loss | $ | (97,246 | ) | $ | (126,502 | ) | $ | (250,470 | ) | $ | (247,115 | ) | |||
| Net loss per common share – basic and diluted | $ | (0.47 | ) | $ | (0.73 | ) | $ | (1.22 | ) | $ | (1.43 | ) | |||
| Weighted-average common shares outstanding – basic and diluted | 206,667,558 | 173,643,829 | 206,143,035 | 172,295,320 | |||||||||||
| IMMUNOVANT, INC. Condensed Consolidated Balance Sheets (Unaudited, in thousands, except share and per share data) | |||||||
| September 30, 2026 | March 31, 2026 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 722,274 | $ | 902,110 | |||
| Accounts receivable | 138 | 1,133 | |||||
| Prepaid expenses and other current assets | 37,634 | 45,576 | |||||
| Total current assets | 760,046 | 948,819 | |||||
| Property and equipment, net | 262 | 443 | |||||
| Other assets | 659 | 7,752 | |||||
| Total assets | $ | 760,967 | $ | 957,014 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 6,787 | $ | 7,541 | |||
| Accrued expenses and other current liabilities | 97,235 | 96,881 | |||||
| Total current liabilities | 104,022 | 104,422 | |||||
| Total liabilities | 104,022 | 104,422 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Series A preferred stock, par value authorized, issued and outstanding at September 30, 2026 and March 31, 2026 | — | — | |||||
| Preferred stock, par value authorized, no shares issued and outstanding at September 30, 2026 and March 31, 2026 | — | — | |||||
| Common stock, par value authorized, 206,785,540 shares issued and outstanding at September 30, 2026 and 500,000,000 shares authorized, 203,940,353 shares issued and outstanding at March 31, 2026 | 20 | 20 | |||||
| Additional paid-in capital | 2,652,005 | 2,596,971 | |||||
| Accumulated other comprehensive income | 519 | 730 | |||||
| Accumulated deficit | (1,995,599 | ) | (1,745,129 | ) | |||
| Total stockholders’ equity | 656,945 | 852,592 | |||||
| Total liabilities and stockholders’ equity | $ | 760,967 | $ | 957,014 | |||
| IMMUNOVANT, INC. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited, in thousands) | |||||||||||
| Three months ended September 30, | |||||||||||
| Note | 2026 | 2025 | |||||||||
| Net loss: | $ | (97,246 | ) | $ | (126,502 | ) | |||||
| Adjustments | |||||||||||
| Research and development: | |||||||||||
| Stock-based compensation | (1 | ) | 6,552 | 7,706 | |||||||
| General and administrative: | |||||||||||
| Stock-based compensation | (1 | ) | 6,729 | 5,652 | |||||||
| Estimated income tax impact from adjustments | — | (164 | ) | ||||||||
| Adjusted net loss (Non-GAAP) | $ | (83,965 | ) | $ | (113,308 | ) | |||||
| Three months ended September 30, | |||||||||
| Note | 2026 | 2025 | |||||||
| Research and Development Expenses | $ | 85,011 | $ | 114,249 | |||||
| Adjustments: | |||||||||
| Stock-based compensation | (1 | ) | 6,552 | 7,706 | |||||
| Adjusted research and development expenses (Non-GAAP) | $ | 78,459 | $ | 106,543 | |||||
| Three months ended September 30, | |||||||||
| Note | 2026 | 2025 | |||||||
| General and Administrative Expenses | $ | 19,144 | $ | 17,513 | |||||
| Adjustments: | |||||||||
| Stock-based compensation | (1 | ) | 6,729 | 5,652 | |||||
| Adjusted general and administrative expenses (Non-GAAP) | $ | 12,415 | $ | 11,861 | |||||
(1) Represents non-cash stock-based compensation expense
| IMMUNOVANT, INC. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited, in thousands) | |||||||||||
| Six Months Ended September 30, | |||||||||||
| Note | 2026 | 2025 | |||||||||
| Net loss: | $ | (250,470 | ) | $ | (247,115 | ) | |||||
| Adjustments | |||||||||||
| Research and development: | |||||||||||
| Stock-based compensation | (1 | ) | 13,806 | 15,571 | |||||||
| General and administrative: | |||||||||||
| Stock-based compensation | (1 | ) | 13,249 | 16,297 | |||||||
| Estimated income tax impact from adjustments | — | (122 | ) | ||||||||
| Adjusted net loss (Non-GAAP) | $ | (223,415 | ) | $ | (215,369 | ) | |||||
| Six Months Ended September 30, | |||||||||
| Note | 2026 | 2025 | |||||||
| Research and Development Expenses | $ | 227,642 | $ | 215,449 | |||||
| Adjustments: | |||||||||
| Stock-based compensation | (1 | ) | 13,806 | 15,571 | |||||
| Adjusted research and development expenses (Non-GAAP) | $ | 213,836 | $ | 199,878 | |||||
| Six Months Ended September 30, | |||||||||
| Note | 2026 | 2025 | |||||||
| General and Administrative Expenses | $ | 36,836 | $ | 43,537 | |||||
| Adjustments: | |||||||||
| Stock-based compensation | (1 | ) | 13,249 | 16,297 | |||||
| Adjusted general and administrative expenses (Non-GAAP) | $ | 23,587 | $ | 27,240 | |||||
(1) Represents non-cash stock-based compensation expense
Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com
Media
Stephanie Lee
stephanie.lee@roivant.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Immunovant’s IMVT-1402 rheumatoid arthritis trial show?
IMVT-1402 600 mg met the Week 28 ACR20 primary endpoint, with 92.5% responding versus 75.6% on placebo (p=0.0139). The 300 mg group had a 75.0% response rate and did not differ from placebo (p=0.9426). The results came from the randomized withdrawal period following an open-label lead-in.
Who entered the randomized period of Immunovant’s rheumatoid arthritis trial?
Participants with an ACR20 response at both Weeks 14 and 16 were eligible for Period 2. The open-label lead-in enrolled 170 participants receiving 600 mg for 16 weeks. The Period 2 efficacy analysis included 117 participants: 40 assigned to 600 mg, 36 to 300 mg and 41 to placebo.
Why did Immunovant’s quarterly research and development spending decline?
The company attributes the decline primarily to batoclimab trial wind-down activities and lower IMVT-1402 trial costs, with the latter driven by contract manufacturing timing. Research and development expenses for the three months ended September 30, 2026 were $85.0 million, compared with $114.2 million a year earlier.
What do the disease-activity endpoints in Immunovant’s rheumatoid arthritis trial mean?
The Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) measure disease activity, with decreases indicating improvement. From Period 2 baseline to Week 28, least squares mean CDAI changes were -0.3 for 600 mg versus +3.1 for placebo (p=0.1096); SDAI changes were +0.1 versus +3.5 (p=0.1299).