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ROIV FDA decision: Aug 27, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

LISRAYA (brepocitinib), a first-in-class oral TYK2/JAK1 inhibitor from Priovant (a Roivant company), approved for adults with dermatomyositis (Aug 27 2026).

Run-up into the decision (T-120 → T+5)

PDUFA 8/27/26$37.4$26.413/6/26
Daily close, T-120 (3/6/26) through T+5. Run-up high $37.4 on 8/19/26, low $26.41 on 3/30/26 (T-120 to T-1). FDA decision 8/27/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-08-27
OutcomeApproved
Drug / candidateLISRAYA (brepocitinib)
IndicationDermatomyositis in adults
CompanyRoivant Sciences Ltd. (Priovant Therapeutics)
Market-cap tierLarge
120-day run-up (T-120→T-1)+27.7%
Cohort decision-day move (history)1.0% median (n=833)

The PDUFA goal date was September 30, 2026, under Priority Review granted at the March 2026 NDA acceptance. The FDA approved on August 27, 2026, 34 days early. LISRAYA is the first targeted oral therapy approved for dermatomyositis, supported by the Phase 3 VALOR study of 241 adults. Priovant Therapeutics is a Roivant subsidiary in which Pfizer holds a stake; Pfizer originated brepocitinib.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.

Primary source: Roivant investor release, August 27, 2026