Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Study Phase : Approved FDF
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.
Product Name : Enjaymo
Product Type : Antibody
Upfront Cash : $825.0 million
April 10, 2024
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Recordati
Deal Size : $1,075.0 million
Deal Type : Acquisition
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Enjaymo
Product Type : Antibody
Upfront Cash : Inapplicable
November 17, 2022
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Enjaymo
Product Type : Antibody
Upfront Cash : Inapplicable
September 16, 2022
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Enjaymo
Product Type : Antibody
Upfront Cash : Inapplicable
September 16, 2022
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Enjaymo
Product Type : Antibody
Upfront Cash : Inapplicable
April 02, 2022
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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).
Product Name : Enjaymo
Product Type : Antibody
Upfront Cash : Inapplicable
November 06, 2021
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Enjaymo
Product Type : Antibody
Upfront Cash : Inapplicable
July 04, 2021
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Enjaymo
Product Type : Antibody
Upfront Cash : Inapplicable
November 14, 2020
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Enjaymo
Product Type : Antibody
Upfront Cash : Inapplicable
May 14, 2020
Lead Product(s) : Sutimlimab
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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