PHAR PDUFA Date: Leniolisib

Name: Leniolisib FDA decision
Start: 2026-10-24
End: 2026-10-24

Updated August 7, 2026·next FDA decision on the calendar

FDA decision (PDUFA) target 2026-10-24 · Pharming Group N.V. · Activated phosphoinositide 3-kinase delta syndrome (APDS)

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The story

Leniolisib is under FDA review to treat activated PI3K-delta syndrome (APDS) - a rare inherited immune disorder.

Full PDUFA calendar ->Every upcoming FDA decision date, by month ARQT . 2026-06-29Same area: Immunology / Dermatology . ZORYVE (roflumilast) Cream 0.3%PFE-brepocitinib . 2026-09-30Same area: Immunology / Dermatology . Brepocitinib RHHBY-tecentriq . 2026-10-09Same month decision . Tecentriq (atezolizumab) and Tecentriq

Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

PHAR run-up into the PDUFA (last ~120 days)

Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-10-24

Drug / candidateLeniolisib

IndicationActivated phosphoinositide 3-kinase delta syndrome (APDS)

CompanyPharming Group N.V.

Market-cap tierSmall

Cohort decision-day move (history)±3% median

ClinicalTrials.govNCT05438407

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FAQ

When is the PHAR PDUFA date?

The FDA PDUFA target date for PHAR (Pharming Group N.V.) is 2026-10-24 for Leniolisib. Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is PHAR's drug Leniolisib?

Leniolisib is Pharming Group N.V.'s candidate under FDA review for Activated phosphoinositide 3-kinase delta syndrome (APDS).

What typically happens to a small-cap stock into a PDUFA date?

Historically, small-cap names had a median decision-day move around ±3% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.

Decision-day move · small-cap cohortn=274 · median +0.0% · 49% up

Distribution of next-day % moves after the FDA decision for small-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.