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NVCR FDA decision: Feb 12, 2026

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

Optune Pax was approved by the FDA for locally advanced pancreatic cancer; the approval was announced on February 12, 2026.

NovoCure Limited, Optune Pax · Locally advanced pancreatic cancer.

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

PDUFA 2/12/26$14.87$10.038/28/25
Daily close, T-120 (8/28/25) through T+5. Run-up high $14.87 on 1/9/26, low $10.03 on 2/9/26 (T-120 to T-1). FDA decision 2/12/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-02-12
OutcomeApproved
Drug / candidateOptune Pax
CompanyNovoCure Limited
120-day run-up (T-120→T-1)-11.8%

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

Questions

Was Optune Pax approved by the FDA?

Yes. The approval of the application for Optune Pax was announced on February 12, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.

Which company is behind Optune Pax?

Optune Pax is a NovoCure Limited (NVCR) program. The company announced the FDA decision on February 12, 2026; the primary source is linked on this page.

How did NVCR stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), NVCR moved -11.8%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.