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PGEN FDA decision: May 27, 2026

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

PAPZIMEOS (zopapogene imadenovec-drba) was approved by the FDA for recurrent Respiratory Papillomatosis (RRP); the approval was announced on May 27, 2026.

Precigen Inc., PAPZIMEOS (zopapogene imadenovec-drba) · Recurrent Respiratory Papillomatosis (RRP).

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

PDUFA 5/27/26$5.21$3.112/10/25
Daily close, T-120 (12/10/25) through T+5. Run-up high $5.21 on 2/19/26, low $3.1 on 3/27/26 (T-120 to T-1). FDA decision 5/27/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-05-27
OutcomeApproved
Drug / candidatePAPZIMEOS (zopapogene imadenovec-drba)
CompanyPrecigen Inc.
120-day run-up (T-120→T-1)+21.8%

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