Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Recordati
Deal Size : $1,075.0 million
Deal Type : Acquisition
Recordati Buys Rights to Rare Immune Disorder Drug from Sanofi for $825M
Details : Recordati will acquire the global rights to Enjaymo (sutimlimab), a biologic and the only approved targeted product for cold agglutinin disease, a rare B-cell lymphoproliferative disorder.
Brand Name : Enjaymo
Molecule Type : Large molecule
Upfront Cash : $825.0 million
October 04, 2024
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Recordati
Deal Size : $1,075.0 million
Deal Type : Acquisition
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Enjaymo (sutimlimab) is a humanized monoclonal antibody that is designed to selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system. Enjaymo inhibits the activation of the complement cascade in th...
Brand Name : Enjaymo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 17, 2022
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Enjaymo (sutimlimab) is a humanized monoclonal antibody. By blocking C1s, Enjaymo inhibits the activation of the complement cascade in the immune system and inhibits C1-activated hemolysis in CAD to prevent the abnormal destruction of healthy RBCs.
Brand Name : Enjaymo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 16, 2022
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Enjaymo™ (sutimlimab) is a humanized monoclonal antibody that is designed to selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system.
Brand Name : Enjaymo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 16, 2022
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Enjaymo, selectively target and inhibit C1s is the only approved treatment to decrease the need for red blood cell transfusion due to hemolysis, the destruction of red blood cells, in adults with cold agglutinin disease.
Brand Name : Enjaymo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 04, 2022
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Sanofi
Deal Size : Not Applicable
Deal Type : Not Applicable
New Pivotal Data at EHA 2021 reinforces Sutimlimab as A First-in-Class Investigational C1s Inhibitor
Details : The CADENZA trial is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of sutimlimab in patients with CAD without a recent history of blood transfusion (within the past 6 months).
Brand Name : BIVV009
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 11, 2021
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Sanofi
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Data from the pivotal Phase 3 CARDINAL study demonstrated sutimlimab inhibited C1-activated hemolysis (abnormal destruction of healthy red blood cells) within one week of treatment and had a sustained treatment effect over the course of the study.
Brand Name : BIVV009
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 07, 2021
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease.
Brand Name : BIVV009
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 14, 2020
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sanofi Gets Priority FDA Review for Sutimlimab Product
Details : Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. If approved, sutimlimab would be the first and only approved treatment for these patients.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 14, 2020
Lead Product(s) : Sutimlimab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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