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Home › FDA Decisions › ANTE 2025-04-23

ANTE FDA Decision Approved · 2025-04-23

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

$0.76$0.4
Historical price action; green = local high, red = low/sell-off.

Decision facts

FDA decision date2025-04-23
Drugpenpulimab-kcqx (penpulimab-kcqx)
IndicationNasopharyngeal carcinoma (recurrent/metastatic)
Outcome✓ Approvedprimary-sourced
Decision-day move-14.1%
T-120 run-up (low→high)+303.0% ($0.39→$1.61)
ValidationVerified 2026-08-12: Drugs@FDA, application BLA761258, action date 2025-04-23
See the full 2026 PDUFA calendar →

Questions

Was penpulimab-kcqx (penpulimab-kcqx) approved by the FDA?

Yes. The FDA approved the application for penpulimab-kcqx (penpulimab-kcqx) on April 23, 2025. The primary source is linked on this page.

What was penpulimab-kcqx (penpulimab-kcqx) under FDA review for?

The application covered Nasopharyngeal carcinoma (recurrent/metastatic). The FDA approved the application on April 23, 2025.

How did ANTE stock react to the FDA decision?

On the decision day ANTE moved -14.1%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.