Roivant Sciences Targets LISRAYA Launch, Key Pipeline Readouts in Next 12 Months

Key Points

• Roivant is launching LISRAYA for dermatomyositis while awaiting Phase III data in non-infectious uveitis later this year, which could provide a second approved indication.
• Key upcoming Immunovant readouts include randomized Phase II data for IMVT-1402 in difficult-to-treat rheumatoid arthritis and proof-of-concept results in cutaneous lupus; Graves’ disease is expected to be a major 2027 catalyst.
• Positive Phase II data for mosliciguat in pulmonary hypertension associated with interstitial lung disease is prompting Roivant to prioritize and expand its Phase III pipeline, while generally favoring development of core assets over sales.

Roivant Sciences NASDAQ: ROIV CEO Matthew Gline outlined the company’s priorities for the next 12 months, including the launch of LISRAYA, upcoming clinical data for brepocitinib and Immunovant’s IMVT-1402, and expansion of its pulmonary hypertension program.

Gline said Roivant recently received approval for brepocitinib, now marketed as LISRAYA, in dermatomyositis and reported positive Phase II data for once-daily inhaled soluble guanylate cyclase stimulator mosliciguat in pulmonary hypertension associated with interstitial lung disease, or PH-ILD.

LISRAYA Launch and Uveitis Readout

Roivant is in the early stages of the LISRAYA launch in dermatomyositis, where Gline said the company’s approach remains “slow and steady.” He said it was too soon, roughly three weeks after launch, to draw conclusions regarding prescriptions, reimbursement or coverage, although he cited enthusiasm from key opinion leaders.

“We’re focused on the launch itself, and focused on net sales as the ultimate judgment,” Gline said, adding that Roivant has not committed to specific launch metrics it will disclose on earnings calls.

The company also expects Phase III data for brepocitinib in non-infectious uveitis during the second half of the year. Gline said Roivant had not yet seen the data. If successful, the program could support a second registered indication for LISRAYA.

He described non-infectious uveitis as the third-leading cause of blindness in the United States and said there has been limited therapeutic innovation. Gline said Roivant’s Phase II results compared favorably with historical HUMIRA data, though he noted that the comparison was across trials. He expects a base-case commercial position in patients whose disease is refractory to TNF therapies, while stronger data could support use earlier in treatment.

Immunovant Programs Focus on RA, Lupus and Graves’ Disease

Later this year, Roivant expects to provide updates on IMVT-1402, an anti-FcRn antibody being developed through Immunovant, including randomized Phase II data in difficult-to-treat rheumatoid arthritis and headline data from a cutaneous lupus erythematosus, or CLE, proof-of-concept study.

Gline said the rheumatoid arthritis study enrolled patients who had failed at least two biologic classes. In the open-label portion, about 70% of patients achieved an ACR20 response, about 50% achieved ACR50 and about 35% achieved ACR70, according to Gline. He said the depth of those responses could make the randomized withdrawal portion of the trial harder to interpret, because patients would need to lose substantial responses to meet the primary endpoint.

Roivant’s principal objective for the randomized data is to avoid findings that would prevent a Phase III program, Gline said. The larger question is the potential regulatory path, including the size and number of studies the Food and Drug Administration may require for a late-line rheumatoid arthritis population with limited treatment options.

For CLE, Gline characterized the study as an “option bet” rather than a central part of the company’s investment thesis. He said Roivant would need to see strong data to justify a Phase III investment, given a growing competitive field and the potential dosing advantages of other mechanisms. He also said a small CLE study would not independently validate or invalidate FcRn inhibition across lupus-spectrum diseases.

Graves’ disease represents a major 2027 catalyst for IMVT-1402. Gline said the biology is straightforward because pathogenic antibodies drive the disease, and he described the company’s Phase II results as unequivocal. However, he also noted operational and endpoint risks, including limited modern trial precedent in Graves’ disease and the complexity of anti-thyroid drug titration.

Roivant is studying patients who remain uncontrolled on anti-thyroid drugs or cannot discontinue them because of side effects. Gline said the company estimates there are approximately 350,000 uncontrolled Graves’ disease patients in the U.S. and approximately 20,000 patients annually who undergo thyroid removal surgery.

In Phase II, he said nearly 60% of patients were able to discontinue or meaningfully reduce anti-thyroid drugs while achieving thyroid hormone normalization. He also said 17 of 21 patients remained controlled six months after discontinuing therapy. One Phase III study includes responder re-randomization intended to generate placebo-adjusted remission data.

Mosliciguat and Pipeline Expansion

Following the positive PH-ILD Phase II result for mosliciguat, Roivant is reassessing the sequence and prioritization of additional indications. Gline said the company began its Phase III study at risk about six months earlier to avoid delays if the data were positive.

He said Roivant generally does not disclose a new indication until a study has begun, partly because FcRn development is competitive and preserving a lead can be valuable. As current programs complete studies, including non-infectious uveitis and Immunovant’s Graves’ disease and myasthenia gravis trials, Gline said the company expects capacity to initiate further studies across its portfolio.

On business development and potential asset sales, Gline said Roivant’s default strategy is to build a larger, durable company around its current pipeline rather than sell core programs. Still, he said the company remains economically driven and would consider sufficiently attractive offers.

About Roivant Sciences (NASDAQ:ROIV)

Roivant Sciences Ltd. is a biopharmaceutical company focused on discovering, developing and commercializing medicines for patients with significant unmet medical needs. The company concentrates on areas including immunology, dermatology, oncology and other specialty conditions, using a combination of internally developed programs, external licensing and strategic acquisitions.

Roivant organizes many of its drug-development activities through subsidiary companies known as “Vants.” These businesses are designed to advance individual therapeutic programs or groups of related assets, while Roivant provides operational, scientific and strategic support.

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