Roivant Sciences (NASDAQ:ROIV) executives highlighted new Phase II results for brepocitinib in cutaneous sarcoidosis, along with a set of broader clinical and corporate milestones, during the company’s third quarter fiscal 2025 earnings call covering the period ended December 31, 2025.
Chief Executive Officer Matt Gline said the quarter included “terrific execution and progress across the board,” pointing to multiple development updates beyond the cutaneous sarcoidosis readout. These included the filing of a new drug application (NDA) for brepocitinib in dermatomyositis, full enrollment in a Phase IIb trial of IMVT-1402 in difficult-to-treat rheumatoid arthritis (D2T-RA), and full enrollment in a Phase II trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company also reiterated that a jury trial in its litigation against Moderna is scheduled to begin March 9.
Phase II cutaneous sarcoidosis results for brepocitinib
The Phase II study enrolled 31 U.S. patients and randomized them 3:2:2 to brepocitinib 45 mg, brepocitinib 15 mg, or placebo for 16 weeks. Zimmer emphasized that baseline imbalances worked “harder” against the 45 mg arm demonstrating efficacy, citing longer disease duration and more plaque-predominant morphology—often considered more treatment-resistant—in the higher-dose group.
On efficacy, management highlighted improvements across physician-assessed and patient-reported outcomes:
- CSAMI activity score: Both brepocitinib doses separated statistically from placebo as early as week 4 (the first assessed time point) and remained separated through week 16. Gline said the placebo-adjusted difference was approximately 21.6 points, noting the study was not powered for efficacy on that endpoint.
- IGA 0/1 with a two-point reduction: Zimmer said this “very high bar” endpoint had zero placebo responders, with improvements emerging by week 4 and reaching statistically significant separation at weeks 12 and 16. He noted 45 mg began to separate from 15 mg on more stringent measures.
- Responder analyses: Zimmer and Gline both highlighted that 100% of patients on brepocitinib 45 mg achieved at least a 10-point CSAMI improvement. The company had previously described 5 points as a minimum clinically important difference.
- Functional remission (CSAMI < 5): Zimmer said 62% of patients on 45 mg reached a CSAMI activity score below 5 at week 16, compared with no placebo patients.
- Patient-reported outcomes: Improvements were reported on Skindex-16 and the King Sarcoidosis Questionnaire (KSQ) skin domain, with placebo worsening on Skindex-16, according to Zimmer. On the Patient Global Impression of Change, 100% of patients on 45 mg reported improvement; he added that two patients in the 15 mg group reported worsening.
Zimmer said the treatment effect appeared rapid and sustained over the 16-week period. When asked about the potential for “erosion” from Phase II to Phase III, he said the observed effect size provided “an incredible cushion,” while also cautioning that placebo behavior can differ in larger global trials.
Safety observations and organ involvement
On safety, Zimmer said brepocitinib was “very well tolerated” in the cutaneous sarcoidosis study, with no serious adverse events and all adverse events graded as mild or moderate. He added that the company has a broader safety database of more than 1,500 brepocitinib-treated patients across studies.
In response to a question about systemic disease manifestations, Zimmer said approximately 60% of trial participants had some pulmonary involvement and roughly 30% (inclusive of those with pulmonary involvement) had other organ involvement, mostly ocular. He noted exploratory endpoints were collected but had not yet been analyzed, and the trial was not designed to evaluate efficacy in non-skin organs.
Phase III planning in cutaneous sarcoidosis
Roivant said it expects to begin a Phase III study of brepocitinib in cutaneous sarcoidosis in 2026. Executives said final details—including sample size and dose selection—will depend on FDA discussions. Zimmer said the company entered the Phase II trial with a hypothesis supporting 45 mg as a strong benefit-risk option based on the broader dataset, and said the new results reinforced that view, while also noting 15 mg “performed very well.”
Gline also said the company continues to evaluate additional expansion opportunities for brepocitinib, including in and outside sarcoidosis, and reiterated that the drug’s combined JAK1/TYK2 mechanism is a focus for selecting future indications.
Other pipeline updates and 2026 catalysts
Beyond cutaneous sarcoidosis, management outlined several upcoming data events and operational milestones:
- Brepocitinib dermatomyositis: Gline said the NDA is now filed. Asked about the possibility of priority review, he said dermatomyositis is severe with limited options and that priority review is possible, but ultimately up to the FDA.
- Brepocitinib NIU: The company reiterated that the pivotal Phase III readout in non-infectious uveitis is expected in the second half of 2026.
- IMVT-1402 (Immunovant): Roivant said the Phase IIb D2T-RA trial is fully enrolled, with 170 patients enrolled versus 120 anticipated. Management said data are expected in the second half of 2026, and indicated it may wait to report results until the randomized withdrawal portion is complete.
- Mosliciguat (Pulmovant): The Phase II PH-ILD study is fully enrolled, with Phase IIb data expected in the second half of 2026. Gline said the company is pursuing a targeted delivery approach and a once-daily regimen, and referenced prior results showing “best-ever” pulmonary vascular resistance (PVR) reductions in a pulmonary arterial hypertension (PAH) population, while noting the need to see whether that translates to PH-ILD.
- Moderna litigation: Gline said the jury trial is scheduled for March 9 and noted a favorable summary judgment decision related to Section 1498, which he said sets up a trial covering “almost all” of the asserted doses.
Quarterly financial update and cash position
Roivant reported R&D expense of $165 million for the quarter, or $147 million on an adjusted non-GAAP basis. G&A expense was $175 million, or $71 million adjusted non-GAAP. The company reported a total non-GAAP net loss of $167 million.
Gline said consolidated cash totaled $4.5 billion and described the balance sheet as “very strong,” adding that the company has “plenty of capital to get us to profitability” and reiterated that it still has share buyback authorization.
About Roivant Sciences (NASDAQ:ROIV)
Roivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines.
The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women’s health.
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