01—Abstract
Summary
Summary of the 8-K filed September 3, 2025. Cited figures are marked; the original filing is the authoritative source.
Roivant Sciences Ltd. (ROIV) reported on September 3, 2025 an update on the Graves' disease proof-of-concept study of batoclimab at its subsidiary Immunovant, Inc. (Nasdaq: IMVT).
Of 21 patients who entered the 24-week off-treatment follow-up, ~80%a (17/21) maintained T3/T4 values at or below the upper limit of normal at Week 48. Of those 17 responders, ~50% (8/17) were in anti-thyroid drug (ATD)-free remission, and an incremental ~30% (5/17) were on ATD doses of 2.5 mg/day. The company states that safety and tolerability were consistent with prior batoclimab studies.
The company describes these results as the first-ever potentially disease-modifying therapy for uncontrolled Graves' disease patients, though the study enrolled 25 patients and the filing presents the data as an abstract to be presented at the 2025 American Thyroid Association Annual Meeting on September 11, 2025. The filing also highlights the lead compound IMVT-1402, for which two potentially registrational trials in Graves' disease are enrolling, with topline readouts expected in 2027. The trials will evaluate a 600 mg dose for up to 52 weeks without a step-down in dose, which the company says is designed to potentially improve efficacy relative to batoclimab's step-down regimen.
Roivant hosted an investor conference call and webcast at 4:30 p.m. EDT on September 3, 2025, and posted a presentation on its investor relations website. The Item 7.01 and Item 8.01 disclosures are furnished rather than filed under the Exchange Act, and the filing's forward-looking statements warn that early trial results may not predict later outcomes and that Immunovant will require additional capital.
02—Key points
Key Highlights
- Six-month off-treatment data: 17 of 21 patients (~80%) who entered the off-treatment follow-up maintained T3/T4 values at or below the upper limit of normal at Week 48.
- ATD-free remission: 8 of the 17 responders (~50%) were in ATD-free remission six months after batoclimab treatment ended, and 5 of 17 (~30%) were on ATD doses of 2.5 mg/day.
- Study design: 25 patients received a 24-week treatment period with batoclimab, stepping down from 680 mg weekly to 340 mg weekly, followed by a 24-week off-treatment period.
- Safety: The company states safety and tolerability were consistent with prior batoclimab studies.
- IMVT-1402 pivotal program: Two potentially registrational Graves' disease trials are enrolling, testing 600 mg with no step-down for up to 52 weeks, with topline readouts expected in 2027.
- Upcoming catalyst: The data will be presented at the 2025 American Thyroid Association Annual Meeting on September 11, 2025.
- Investor call: Roivant hosted a call and webcast at 4:30 p.m. EDT on September 3, 2025, with the presentation posted on its investor relations website.
03—Questions
Frequently Asked Questions
What did the Graves' disease study show about durability of response?
According to the filing, 17 of the 21 patients (~80%) who entered the six-month off-treatment follow-up maintained T3/T4 values at or below the upper limit of normal at Week 48, which the company describes as strong durability of response.
How many patients achieved ATD-free remission?
Of the 17 responders, 8 (~50%) were in ATD-free remission at six months after batoclimab treatment ended. An additional 5 of the 17 (~30%) were on ATD doses of 2.5 mg/day.
What is the company's next step for IMVT-1402 in Graves' disease?
Two potentially registrational trials are currently enrolling. They will evaluate a 600 mg weekly dose for up to 52 weeks without a step-down, with topline readouts expected in 2027.
Why does the company say IMVT-1402 trial design could differ from batoclimab's?
The filing states that IMVT-1402 uses continuous 600 mg weekly dosing without the step-down used in batoclimab's study, which the company says could generate improved efficacy data.
Are these results final, and what are the stated risks?
The data are presented as an abstract for the 2025 American Thyroid Association Annual Meeting on September 11, 2025. The forward-looking statements caution that initial or preliminary results of early clinical trials may not predict final or later-stage results, and that Immunovant will require additional capital to advance its programs.
04—Continue