pdufa.bio
Home › Decisions › PFE 2026-02-24

PFE FDA decision: Feb 24, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

BRAFTOVI (encorafenib) was approved by the FDA for BRAF V600E-Mutant Metastatic Colorectal Cancer; the approval was announced on February 24, 2026.

Pfizer Inc., BRAFTOVI (encorafenib) · BRAF V600E-Mutant Metastatic Colorectal Cancer.

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

PDUFA 2/24/26$27.73$23.69/9/25
Daily close, T-120 (9/9/25) through T+5. Run-up high $27.73 on 2/12/26, low $23.6 on 10/2/25 (T-120 to T-1). FDA decision 2/24/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-02-24
OutcomeApproved
Drug / candidateBRAFTOVI (encorafenib) in combination with c
CompanyPfizer Inc.
120-day run-up (T-120→T-1)+8.3%

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.