Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis
Roivant Sciences Ltd. (ROIV)
Company Research
Source: GlobeNewswire
FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026Priority Review supported by positive Phase 3 VALOR results, the first positive 52-week placebo-controlled trial in dermatomyositisIf approved, brepocitinib would represent the first targeted therapy approved for dermatomyositis DURHAM, N.C., March 03, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for brepocitinib for the treatment of dermatomyositis (DM) and has granted the application Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of calendar year 2026. The company expects to launch the drug in the United States at the end of September 2026. The FDA grants Priority Review to applications for medicines that, if approved, provide significant improvements in the safety or
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News
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- Roivant Sciences (ROIV) had its "buy" rating reaffirmed by TD Cowen.MarketBeat
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- Roivant Sciences (ROIV) had its price target raised by HC Wainwright from $33.00 to $34.00. They now have a "buy" rating on the stock.MarketBeat
ROIV
Earnings
- 2/6/26 - In-Line
ROIV
Sec Filings
- 3/3/26 - Form 8-K
- 3/3/26 - Form 8-K
- 2/24/26 - Form 4
- ROIV's page on the SEC website