Roivant executives used the company’s fourth-quarter and fiscal-year earnings call to highlight new clinical data from its development portfolio, upcoming readouts and its strengthened balance sheet following a settlement with Moderna.
Matthew Klein, CEO of Roivant, said the company has had “a pretty wild 12 months,” citing progress across multiple programs and a series of expected milestones over the next year. The most prominent update was preliminary open-label data from a study of IMVT-1402 in difficult-to-treat rheumatoid arthritis, a program run by Immunovant (NASDAQ:IMVT).
IMVT-1402 Shows Open-Label Activity in Difficult-to-Treat Rheumatoid Arthritis
Klein said the preliminary open-label period data from the 1402 study in difficult-to-treat rheumatoid arthritis were “surprisingly good,” while cautioning that the results came from an open-label portion of the trial.
The study enrolled heavily refractory patients who had failed steroids, DMARDs and at least two advanced lines of therapy. Roivant said the trial also required ACPA positivity above a specified threshold. The study included 165 evaluable patients, with a baseline DAS28 CRP score of 6.1, which Klein described as reflecting “quite a sick patient population.”
In the 16-week open-label treatment period, patients received 600 milligrams of IMVT-1402. Roivant reported approximately 73% ACR20 responses, more than half of patients achieving ACR50 responses and more than one-third achieving ACR70 responses.
Klein said the depth of responses was particularly notable. “Once you get onto the deeper end of that with ACR 50s and ACR 70s, you just don’t see a lot of placebo response in that level of responder analysis,” he said.
The company also highlighted a subset of 107 patients who were both JAK inhibitor- and TNF-experienced. Klein said the response rates were “basically fully preserved” in that group, which he said supported the company’s thesis that targeting autoantibody-positive disease could offer an orthogonal mechanism for patients who have failed other anti-inflammatory therapies.
Roivant said IMVT-1402 was safe and well-tolerated in the study, with no new drug-related safety signals identified. In response to an analyst question, Klein said the company has seen “no impact on albumin or LDL” across hundreds of patients dosed with 1402, though he did not provide specific numerical data from the rheumatoid arthritis trial.
Randomized Withdrawal Data Still Pending
The second period of the rheumatoid arthritis study is a 12-week randomized withdrawal phase in which ACR20 responders from weeks 14 and 16 are re-randomized to 600 milligrams, 300 milligrams or placebo. Klein said that portion is still ongoing, with more than half of patients still being dosed, and no data from that period were shared on the call.
Klein cautioned that the strong open-label responses could make the withdrawal portion harder to interpret. He said the primary endpoint asks whether patients taken off drug lose their ACR20 response within 12 weeks, but patients who achieved ACR50 or ACR70 responses may take longer to fall below the ACR20 threshold.
“There are plenty of scenarios where we don’t see a P value in period 2 and continue forward with the drug given the overall quality of this data,” Klein said. He added that Roivant expects to share more patient-level analysis and feedback from discussions with the FDA in the second half of the year.
Klein said prior commercial analysis suggested the target population could be at least 70,000 patients, while more recent analysis by Immunovant indicated the number could be 85,000 or higher.
Mosliciguat Readout Expected in PH-ILD
Roivant also previewed mosliciguat, an inhaled sGC activator being developed for pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Top-line data from the Phase IIb FOCUS study are expected in the second half of 2026.
Andrew Fromkin, CEO of Priovant, said mosliciguat is designed to activate sGC directly in the lungs and restore impaired sGC function. The company believes the drug could address both pulmonary vascular disease and lung parenchymal disease in PH-ILD.
Fromkin said prior Phase I studies conducted by Bayer included 170 participants, including healthy volunteers and pulmonary hypertension patients. In a Phase Ib study, a single dose of mosliciguat produced a mean PVR reduction of more than 30% and a mean peak PVR reduction of about 38%. Fromkin also said the drug was well-tolerated, with mild-to-moderate treatment-emergent adverse events and no significant cough observed.
The FOCUS study enrolled 135 patients, above the target of 120. The trial is randomized 2-to-1, drug to placebo, and uses change from baseline in pulmonary vascular resistance at week 16 as the primary endpoint. Secondary endpoints include six-minute walk distance and NT-proBNP.
Klein emphasized that the study is not powered to show a statistically significant benefit on six-minute walk distance. “What we’re really looking for is affirmation of dosing, affirmation of safety, affirmation of PVR in this patient population,” he said.
Roivant said PH-ILD affects up to approximately 200,000 patients in the U.S. and Europe and has fewer than five years of median survival in severe subgroups. Fromkin noted that only two FDA-approved treprostinil drugs are currently available.
Brepocitinib Commercial Preparations Continue
Roivant also discussed brepocitinib, including commercial preparations for a potential launch in dermatomyositis by the end of September, assuming FDA action proceeds as expected. Klein said the company is engaged with payers, physicians and specialty pharmacies and has built a commercial team for the launch.
Klein said dermatomyositis patients have limited options, with many treated with steroids, IVIG and off-label therapies. He also noted that Phase III data for brepocitinib were published in the New England Journal of Medicine in March.
Roivant said additional brepocitinib-related catalysts include expected Phase III top-line data in non-infectious uveitis in the second half of the year, the planned start of a Phase III study in cutaneous sarcoidosis this year and an ongoing study in lichen planopilaris. Klein said lichen planopilaris has no FDA-approved therapies and may affect about 100,000 patients in the U.S.
Cash Position Strengthened by Moderna Settlement
Roivant reported $4.3 billion in cash and cash equivalents as of March 31, before accounting for its Moderna settlement. Klein said the company expects to receive the first $950 million upfront payment from the $2.25 billion settlement in July.
The company said it has no debt and continued to repurchase shares during the quarter. Klein said research and development spending has grown over time as the scope of Roivant’s programs has expanded.
Other upcoming milestones include top-line data from a cutaneous lupus erythematosus proof-of-concept study in the second half of the year, ongoing Graves’ disease studies with data expected in 2027, and myasthenia gravis data also expected next year.
About Immunovant (NASDAQ:IMVT)
Immunovant Inc is a clinical-stage biopharmaceutical company focused on the development of novel monoclonal antibody therapies that target the neonatal Fc receptor (FcRn) to treat severe autoimmune diseases. By inhibiting FcRn, Immunovant's approach is designed to reduce levels of pathogenic immunoglobulin G (IgG) antibodies, which play a central role in the pathology of disorders such as myasthenia gravis and immune thrombocytopenia.
The company's lead asset, efgartigimod, is an engineered Fc fragment that selectively binds to FcRn, accelerating the degradation of circulating IgG.
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