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ETON FDA Decision Approved · 2026-02-25

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Price into the decision (T-120)

PDUFA 2/25/26$22.48$14.359/10/25
Daily close, T-120 (9/10/25) through T+5. Run-up high $22.48 on 10/6/25, low $14.35 on 2/6/26 (T-120 to T-1). FDA decision 2/25/26. Historical price action, not a forecast.

Decision facts

FDA decision date2026-02-25
Outcome✓ Approvedprimary-sourced
Decision-day move-3.4%
T-120 run-up (low→high)+4.0% ($14.35→$19.25)
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 ETON, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
EcoR1 Capital2,171,938$78.6 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 primary-sourced approved by the FDA?

Yes. The approval of the application for primary-sourced was announced on February 25, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.

How did ETON stock react to the FDA decision?

On the decision day ETON moved -3.4%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.