Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Leniolisib
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Pharming Begins Phase II Trial of Leniolisib in Primary Immunodeficiencies
Details : Joenja (leniolisib) is an oral small molecule PI3K delta inhibitor, which is currently being evaluated for the treatment of primary immunodeficiency disorders.
Brand Name : Joenja
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 10, 2024
Lead Product(s) : Leniolisib
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Pharming Announces Completion of Enrollment in Pediatric Clinical Trial of Leniolisib
Details : Joenja (leniolisib) is an oral PI3K delta inhibitor, the first targeted treatment for activated PI3K delta syndrome in patients aged 12 and older, now being developed for children aged 4 to 11.
Brand Name : Joenja
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 08, 2024
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Leniolisib
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Joenja (leniolisib) is an oral small molecule PI3Kẟ inhibitor approved in US as the first and only targeted treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
Brand Name : Joenja
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 13, 2023
Lead Product(s) : Leniolisib
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Leniolisib is an oral small molecule phosphoinositide 3-kinase delta inhibitor approved in the US as the first and only targeted treatment of activated phosphoinositide 3-kinase delta syndrome in adult and pediatric patients 12 years of age and older.
Brand Name : CDZ173
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 21, 2023
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with ...
Brand Name : Joenja
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 10, 2023
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with ...
Brand Name : Joenja
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 09, 2023
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved
Sponsor : Novartis Pharmaceuticals Corporation
Deal Size : $21.1 million
Deal Type : Divestment
Pharming Announces Sale of Priority Review Voucher
Details : Under the agreement, Pharming will sell its Rare Pediatric Disease Priority Review Voucher, in connection with the approval of Joenja® (leniolisib), an oral, selective PI3Kδ inhibitor, for activated PI3Kδ syndrome, a rare and progressive primary immun...
Brand Name : Joenja
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 01, 2023
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved
Sponsor : Novartis Pharmaceuticals Corporation
Deal Size : $21.1 million
Deal Type : Divestment
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with ...
Brand Name : Joenja
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 24, 2023
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Leniolisib
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Pharming Announces First Patient Enrolled in Pediatric Clinical Trial of Leniolisib
Details : Leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor. It is being investigated in children with activated phosphoinositide 3-kinase delta syndrome (APDS).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 21, 2023
Lead Product(s) : Leniolisib
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Pharming Provides Update on EMA Regulatory Review of Leniolisib For APDS in Europe
Details : Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K. PI3K delta is a valid and potentially effective therapeutic target for immune diseases such as APDS.
Brand Name : CDZ173
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 16, 2023
Lead Product(s) : Leniolisib
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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