Leniolisib

Phase 3

Pharming Group N.V. (PHAR)

00%

What is LOA?

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

Upcoming Catalysts

What are catalysts?

3mo

PHARPDUFA$766M

Phase 3✓Positive

FDA PDUFA Date Joenja (leniolisib) (priority)

Leniolisib• activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 years and older weighing 13 kg to 27 kg

Jan 30Confirmed

SEC

Nov '26

PHARPhase 3$766M

Leniolisib Phase 3 Est. Readout

Leniolisib• PIDs Linked to PI3K15

Nov 2026~Estimated

CT.gov

00%

Development History

Past

days

PHARPDUFA$766M

Phase 3✅Approved

FDA PDUFA Date Joenja (leniolisib)

Leniolisib• Activated PI3K delta syndrome (APDS) in pediatric patients aged 4 to 11 years

Oct 24AI-detected

SEC

Competitive Landscape

0 competitors in PIDs Linked to PI3K

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Drug Information

Target Indication

PIDs Linked to PI3K

Clinical Trial

NCT06990529

Last updated: 1/22/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMA5/21/2026

Joenja

Joenja is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.

Orphan

View on EMA

Drug Science

Mechanism of action & safety profile

Developer

PHAR

Pharming Group N.V.

Pharmaceutical Preparations•Europe•NASDAQ

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