# Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis
Canonical URL: https://biopharmsignal.com/news/ROIV/priovant-announces-fda-acceptance-and-priority-review-of-new-drug-application-for-brepocitinib-in-dermatomyositis
Ticker: ROIV
Company: Roivant
Source: Roivant
Published: 2026-03-03 12:00 EST
Original Source URL: https://investor.roivant.com
## Summary

FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026 Priority Review supported by positive Phase 3 VALOR results, the first positive 52-week placebo-controlled trial in dermatomyositis If approved, brepocitinib would

## Article Body
FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026 Priority Review supported by positive Phase 3 VALOR results, the first positive 52-week placebo-controlled trial in dermatomyositis If approved, brepocitinib would
## Recent Company News
- 2026-05-20 11:00 EST — [Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026 and Provides Business Update](https://biopharmsignal.com/news/ROIV/roivant-reports-financial-results-for-the-fourth-quarter-and-fiscal-year-ended-march-31-2026-and-provides-business-update) — Source: Roivant
- 2026-05-11 20:05 EST — [Roivant to Report Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026 and Provide Business Update on Wednesday, May 20, 2026](https://biopharmsignal.com/news/ROIV/roivant-to-report-financial-results-for-the-fourth-quarter-and-fiscal-year-ended-march-31-2026-and-provide-business-update-on-wednesday-may-20-2026) — Source: Roivant
- 2026-04-02 09:00 EST — [Priovant Expands Brepocitinib Development Program with New Phase 2b/3 Trial in Lichen Planopilaris (LPP)](https://biopharmsignal.com/news/ROIV/priovant-expands-brepocitinib-development-program-with-new-phase-2b-3-trial-in-lichen-planopilaris-lpp) — Source: Roivant
- 2026-04-02 09:00 EST — [Roivant Announces Expansion of Brepocitinib Development Program with New Phase 2b/3 Trial in Lichen Planopilaris (LPP) and Phase 3 Study Results for Batoclimab in Thyroid Eye Disease (TED)](https://biopharmsignal.com/news/ROIV/roivant-announces-expansion-of-brepocitinib-development-program-with-new-phase-2b-3-trial-in-lichen-planopilaris-lpp-and-phase-3-study-results-for-batoclimab-in-thyroid-eye-disease-ted) — Source: Roivant
- 2026-03-28 19:00 EST — [New England Journal of Medicine Publishes Positive Phase 3 VALOR Trial Results of Brepocitinib in Dermatomyositis](https://biopharmsignal.com/news/ROIV/new-england-journal-of-medicine-publishes-positive-phase-3-valor-trial-results-of-brepocitinib-in-dermatomyositis) — Source: Roivant
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