pdufa.bio
CalendarDecisionsApprovals/yrTrial oddsLearnResearchMethodology
Home › PDUFA Calendar › PHAR

PHAR PDUFA Date: Leniolisib

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

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

$17.8$12
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 · nan

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

Track this live → price, options (expected move & IV) and the full dashboard
Opens the pdufa.bio app (private beta)

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% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.