Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Emapalumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants Priority Review to Sobi's Gamifant sBLA
Details : Gamifant (emapalumab) is an anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity. Emapalumab is currently in Phase lll development for MAS.
Product Name : Gamifant
Product Type : Antibody
Upfront Cash : Inapplicable
February 27, 2025
Lead Product(s) : Emapalumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Emapalumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sobi's Emapalumab-lzsg Gets FDA Fast Track For Macrophage Activation Syndrome
Details : Gamifant (emapalumab) is an anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity. Emapalumab is currently in Phase lll development for MAS.
Product Name : Gamifant
Product Type : Antibody
Upfront Cash : Inapplicable
May 24, 2024
Lead Product(s) : Emapalumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Emapalumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Gamifant (emapalumab-lzsg) is a fully human, anti-IFNγ mAb that binds free and receptor-bound IFNγ, neutralizing its biological activity. In the US, it is indicated for pediatric and adult primary hemophagocytic lymphohistiocytosis (HLH) patients.
Product Name : Gamifant
Product Type : Antibody
Upfront Cash : Inapplicable
April 04, 2023
Lead Product(s) : Emapalumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Emapalumab
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sobi to Present Data from REAL-HLH Study at the ACR Convergence 2022 Meeting
Details : Gamifant (emapalumab-lzsg) is an IFNγ blocking monoclonal antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary HLH with refractory, recurrent or progressive disease or intolerance with conventional HLH th...
Product Name : Gamifant
Product Type : Antibody
Upfront Cash : Inapplicable
October 27, 2022
Lead Product(s) : Emapalumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Emapalumab
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Gamifant (emapalumab) is a mAb that binds to and neutralizes interferon-gamma (IFNy), is the first and only medicine approved in the US and UAE for primary HLH, also has received approval by NMPA of China.
Product Name : Gamifant
Product Type : Antibody
Upfront Cash : Inapplicable
February 25, 2022
Lead Product(s) : Emapalumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Emapalumab
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sobi will File for a Re-Examination of Emapalumab in Europe
Details : Emapalumab has demonstrated a positive benefit/risk profile in primary HLH in a post-approval real life setting in the US since the FDA approval in 2018.
Product Name : Gamifant
Product Type : Antibody
Upfront Cash : Inapplicable
July 24, 2020
Lead Product(s) : Emapalumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Emapalumab
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The results with emapalumab in primary HLH published in the New England Journal of Medicine highlight the overall response rate of 63 percent in previously treated patients at the end of up to 8 weeks of treatment (compared to the pre-specified null hypo...
Product Name : Gamifant
Product Type : Antibody
Upfront Cash : Inapplicable
July 05, 2020
Lead Product(s) : Emapalumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable