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Roivant reports $31M first-launch LISRAYA sales as IMVT-1402 meets primary endpoint in refractory RA

🇺🇸 Roivant Sciences Ltd. (ROIV) · Mon 09 Nov 2026

Roivant's fiscal Q2 update covers early sales of FDA-approved LISRAYA, an uveitis filing plan, a positive rheumatoid arthritis readout for IMVT-1402 and a Phase 3 start for mosliciguat.

Roivant Sciences reported results for its fiscal second quarter, which ended 30 September 2026, on 9 November 2026. The company said LISRAYA (brepocitinib), approved by the US Food and Drug Administration in August 2026, generated $31.0 million in net sales in its first five weeks on the market.

Roivant plans to file a supplemental new drug application (sNDA) for non-infectious uveitis in the first half of 2027. The plan follows positive Phase 3 data from the CLARITY study. An sNDA is the route by which a sponsor asks the FDA to add a new indication to an already approved product.

Immunovant's IMVT-1402 at 600 mg met its primary endpoint, ACR20, in a trial in difficult-to-treat rheumatoid arthritis. ACR20 is a standard measure of at least 20% improvement in rheumatoid arthritis disease criteria. Roivant said discussions with the FDA on the registrational path are planned later this year; no further trial details were provided in the material available.

Mosliciguat also reported positive Phase 2 results in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and has moved into Phase 3, according to the update.

What it means for your team

  • Regulatory teams tracking JAK-class and related immunology products should note the planned H1 2027 sNDA for LISRAYA in non-infectious uveitis.
  • The outcome of Immunovant's FDA discussions on the IMVT-1402 registrational path, expected later this year, will define the development requirements in difficult-to-treat rheumatoid arthritis.
  • Pharmacovigilance and market-access teams can watch the early LISRAYA launch uptake, with $31.0 million in net sales reported for the first five weeks.

Company's press release (SEC filing): Roivant Sciences Ltd. ↗

Article written by VigiEye from the official source (Roivant Sciences Ltd.). Claims are the company's own. AI-assisted; check the source before acting.

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