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LLY FDA Decision Approved · 2025-12-03

Page updated ·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

Price into the decision (T-120)

PDUFA 12/3/25$1109.94$625.656/18/25
Daily close, T-120 (6/18/25) through T+5. Run-up high $1109.94 on 11/26/25, low $625.65 on 8/12/25 (T-120 to T-1). FDA decision 12/3/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 19, 2025, 14 days before the decision date, at-the-money options priced a move of ±6.1% through Dec 5, 2025 (the first listed expiry after the decision; ATM implied volatility 36%). The stock closed -1.2% at the first close across the decision and -6.1% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-12-03
DrugJaypirca (pirtobrutinib)
IndicationRelapsed or refractory CLL/SLL
Outcome✓ Approvedprimary-sourced
Decision-day move-1.2%
T-120 run-up (low→high)+46.0% ($625.65→$1109.94)
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=837)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

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

Specialist biotech funds holding LLY, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
OrbiMed Advisors257,900$309.3 millionfiled 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.

Questions

Was Jaypirca (pirtobrutinib) approved by the FDA?

Yes. The FDA approved the application for Jaypirca (pirtobrutinib) on December 2, 2025, per the FDA's own record. The company announced it on December 3, 2025. The primary source is linked on this page.

What was Jaypirca (pirtobrutinib) under FDA review for?

The application covered Relapsed or refractory CLL/SLL. The FDA approved the application on December 3, 2025.

How did LLY stock react to the FDA decision?

On the decision day LLY moved -1.2%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.