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Home › FDA Decisions › PHAR 2026-02-01

PHAR FDA Decision CRL · 2026-02-01

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
clinical/data CRL: Pharming Joenja pediatric sNDA CRL

Price into the decision (T-120)

PDUFA 2/1/26$21.18$11.258/15/25
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 date2026-02-01
Outcome✗ CRL✓ source-verified
Decision-day move-17.0%
T-120 run-up (low→high)+46.0% ($13.1→$21.18)
CRL reasonclinical/data: Pharming Joenja pediatric sNDA CRL
Primary sourceView filing ↗
Market-cap tierSmall
Cohort decision-day move (history)3.7% median (n=302)

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.

Questions

Was source-verified approved by the FDA?

Not in this review cycle. A Complete Response Letter, declining to approve the application for source-verified in its current form, was announced on February 1, 2026. A CRL is not final; the primary source is linked on this page.

How did PHAR stock react to the FDA decision?

On the decision day PHAR moved -17.0%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.