Biopharma Transcript

Pharming Group N.V. PHAR

Nasdaq · Phase 3 · immunology/inflammation · small molecule · EDGAR · Updated Nov 6, 2026

Pharming Group N.V. (Nasdaq: PHAR) is an immunology/inflammation drug developer. Its lead program, Joenja (leniolisib), is in Phase 3 for Activated PI3K delta syndrome (APDS). Its next catalyst on record is leniolisib: Pharming expects to report Phase II topline results for leniolisib in CVID patients in November 2026. (November 2026).

Upcoming catalysts

  1. November 2026
    leniolisib — Pharming expects to report Phase II topline results for leniolisib in CVID patients in November 2026.Pharming expects to report Phase II results for leniolisib in CVID patients with immune dysregulation, with or without an identified genetic cause, in November 2026.

Next further out: Joenja (leniolisib) — Joenja expected to become available to pediatric patients covered by the expanded U.K. indication in February 2027. (February 2027). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.

Pipeline

ProgramIndicationModalityStage
RUCONEST (recombinant C1 esterase inhibitor)Acute hereditary angioedema attacksprotein/peptideApproved
Joenja (leniolisib)APDSsmall moleculeApproved
KL1333mtDNA-driven primary mitochondrial disease (FALCON pivotal trial)small moleculePhase 3
LeniolisibCVID with immune dysregulation (Phase II)small moleculePhase 2
LeniolisibGenetically defined PIDs with immune dysregulation (CTLA4, SOCS1, NFKB1, FAS) (Phase II)small moleculePhase 2

Recent results and decisions

  1. Nov 6, 2026
    approval U.K. MHRA approves extension of Joenja marketing authorization to include children aged 4 to 11 years weighing at least 27 kg with APDS.The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has approved an extension of the marketing authorization of Joenja®, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, to include children aged 4 to 11 years weighing at least 27kg with activated PI3K delta syndr Filing
  2. Oct 14, 2026
    positive ESID presentation of Phase II data (n=13): mean spleen volume reduction 26.4% (n=11), lymph node index lesion reduction 33.7%, DLCO +8.0%; generally well tolerated.Spleen volume: Mean reduction from baseline of 26.4% (n=11), with reductions observed in 10 of 11 evaluable participants. Filing
  3. Oct 14, 2026
    positive Pharming presented positive topline data from Phase II trial of leniolisib in genetically identifiable PIDs with immune dysregulation at ESID meeting.On October 14, 2026, we presented positive topline data from our Phase II trial of leniolisib in genetically identifiable PIDs with immune dysregulation at the 22nd Biennial Meeting of the European Society for Immunodeficiencies (ESID). Filing

8 more on record.

For subscribers

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