Brepocitinib was approved by the FDA on August 27, 2026 for dermatomyositis (DM), 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), a first-in-class oral TYK2/JAK1 inhibitor from Priovant (a Roivant company), approved for adults with dermatomyositis (Aug 27 2026).
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. 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
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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Perceptive Advisors | 8,085,461 | $286.1 million | filed August 14, 2026 |
| Baker Bros. Advisors | 4,716,831 | $166.9 million | filed August 14, 2026 |
| Cormorant Asset Management | 475,000 | $16.8 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The FDA approved the application for LISRAYA (brepocitinib) on August 27, 2026, per the FDA's own record. The primary source is linked on this page.
LISRAYA (brepocitinib) is a Roivant Sciences Ltd. (Priovant Therapeutics) (ROIV) program. The FDA decision came on August 27, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), ROIV moved +27.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.