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brepocitinib

Priovant Therapeutics / Roivant Sciences · $ROIV
Priority Review Orphan Drug Breakthrough Therapy NDA
PDUFA Date
September 30, 2026
Time Remaining
183 days
Review Type
Priority (6 mo)
93%
Baseline PoA
Orphan/rare disease designation approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$26.41 +154.43%
+$16.03 today
Day: $25.95 – $26.78
Market Cap
N/A
52-Week Range
$8.73
$30.33
Current price is at 82% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.

Indication

Dermatomyositis (DM) — inflammatory myopathy

Key Notes

NDA accepted with Priority Review. PDUFA Q3 2026 with launch expected end of September 2026 (company guidance, confirmed March 3, 2026). TYK2/JAK1 inhibitor. Dermatomyositis is a rare autoimmune inflammatory myopathy with no approved targeted therapies. Phase 3 clinical program supported the NDA. Brepocitinib is also in Phase 3 for non-infectious uveitis. Would be the first FDA-approved targeted therapy specifically for dermatomyositis.
⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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