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Home › PDUFA Calendar › PHAR

Pharming Group N.V. (PHAR) FDA catalysts & readout calendar

Updated ·next FDA decision on the calendar
Pharming Group N.V. · 1 upcoming · 1 past FDA decision

Upcoming FDA catalysts

PHAR · Oct 24, 2026Leniolisib: APDS

FDA decision history (1)

Feb 1, 2026✕ CRLFDA decision

Clinical readouts (1)

2026-11Leniolisib
Full PDUFA calendar →All FDA decisions →Phase readouts →
See the full 2026 PDUFA calendar →

This page aggregates PHAR's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.

PHAR run-up, measured

Computed from this stock's own daily closing prices, on the same T-120 basis as the run-up study: the baseline is the close 120 trading sessions before the eve of the decision. These are measurements of what already happened, not predictions.

Run-up so far, this catalyst
Since its T-120 baseline on 2026-05-05 ($16.17), PHAR is -27.6% to $11.70 at the close on 2026-08-28. The highest close since that baseline is +1.4% above it.
81 of 120 sessions elapsed, 39 to go. Cohort context: across 1,839 past decisions the median peak from T-120 was 17.7% and the median move to the day before the decision was 2.0%.
PHAR's past FDA decisions (n=2)
DecisionOutcomeT-120 to eveT-120 to peak
2026-02-01CRL+54.7%+60.1%
2023-03-24APPROVAL+8.1%+41.7%
With only 2 decisions on record, no median is shown: an average of 2 events would not be a meaningful statistic. The individual figures above are exact. For a statistical base see the run-up study, built on 1,839 decisions.

Common questions

When is the next FDA decision or readout for Pharming Group N.V. (PHAR)?

October 24, 2026. The next catalyst for Pharming Group N.V. is Leniolisib (PDUFA). That date is a confirmed date. One further catalyst is scheduled after it. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.

Has Pharming Group N.V. (PHAR) had an FDA decision before?

Yes, 1 in our archive: 0 approval(s) and 1 Complete Response Letter(s). The most recent was on February 1, 2026 and was a Complete Response Letter. Each one has its own page with the source document and the share-price reaction we measured.

How has PHAR stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Since its T-120 baseline on 2026-05-05 ($16.17), PHAR is -27.6% to $11.70 at the close on 2026-08-28. The highest close since that baseline is +1.4% above it. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.

Where does this PHAR data come from?

FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.