PFE FDA decision: Aug 27, 2026

Brepocitinib (VALOR) was approved by the FDA on August 27, 2026 for dermatomyositis, the 35th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.

Verified against: FDA action day August 27, 2026 (NDA 220106 ORIG-1) · Announcement August 27, 2026 (sponsor announcement) · Goal date none sourced.

LISRAYA (brepocitinib), the Pfizer-originated TYK2/JAK1 inhibitor developed by Priovant, approved for adults with dermatomyositis (Aug 27 2026).

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

Key facts

The sponsor guided this decision to Q3 2026, under Priority Review granted at the March 2026 NDA acceptance. The FDA approved on August 27, 2026. We do not state how early it was: the goal date we hold for this application is not a sourced calendar day, and an unsourced goal cannot measure earliness. The sponsor is Priovant Therapeutics, a Roivant subsidiary; Pfizer originated brepocitinib and holds a stake in Priovant, which is why this event is tracked on both tickers. Supported by the Phase 3 VALOR study of 241 adults.

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

FDA record of the action: the FDA approved on August 27, 2026, per NDA 220106 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.