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Pharming

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Pharming Receives Agreement of Paediatric Investigation Plan and Promising Innovative Medicine Designation for leniolisib from UK MHRA

Details:

An agreed paediatric investigation plan is regulatory pathway to market authorization for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children.

Lead Product(s): Leniolisib

Therapeutic Area: Immunology Product Name: CDZ173

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 26, 2022

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Pharming

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Pharming Announces Positive Data from Phase II/III Leniolisib Trial Presented at Clinical Immunology Society 2022 Annual Meeting

Details:

In index lymphadenopathy lesions, a statistically significant adjusted mean change in log10 transformed sum of product of diameters (SPD) of -0.30 among patients who received leniolisib, inhibit the production of PIP3, compared with -0.06 among patients who received placebo.

Lead Product(s): Leniolisib

Therapeutic Area: Immunology Product Name: CDZ173

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 01, 2022

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Pharming

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Pharming Receives Orphan Drug Designation from EC for Leniolisib for the Treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome

Details:

Leniolisib is a small molecule phosphoinositide 3-kinase delta (PI3Kẟ) inhibitor with immunomodulating and potentially anti-neoplastic activities. Leniolisib inhibits the production of phosphatidylinositol-3-4-5-trisphosphate (PIP3).

Lead Product(s): Leniolisib

Therapeutic Area: Immunology Product Name: CDZ173

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 21, 2020

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