PHAR FDA Decision CRL · 2026-02-01 Updated August 8, 2026 · next FDA decision on the calendar clinical/data CRL: Pharming Joenja pediatric sNDA CRL
Price into the decision (T-120) PDUFA 2/1/26 $21.18 $11.25 8/15/25 Daily close, T-120 (8/15/25) through T+5. Run-up high $21.18 on 1/27/26, low $11.25 on 8/20/25 (T-120 to T-1). FDA decision 2/1/26. Historical price action, not a forecast.
Decision facts FDA decision date 2026-02-01
Outcome ✗ CRL ✓ source-verified
Decision-day move -17.0%
T-120 run-up (low→high) +46.0% ($13.1→$21.18)
CRL reason clinical/data: Pharming Joenja pediatric sNDA CRL
Market-cap tier Small
Cohort decision-day move (history) 3.6% median (n=279)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
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