Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
US FDA Approves Syndax's Blood Cancer Drug
Details : Revuforj (revumenib) is a highly selective, first-in-class oral menin inhibitor, for the treatment of adult and pediatric patients with relapsed/refractory KMT2A-rearranged (KMT2Ar) acute leukemia.
Brand Name : Revuforj
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 15, 2024
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Syndax Announces PDUFA Action Date Extension for Revumenib NDA in KMT2Ar Acute Leukemia
Details : SNDX-5613 (revumenib) is a highly selective, first-in-class oral menin inhibitor, for the treatment of adult and pediatric patients with relapsed/refractory KMT2A-rearranged (KMT2Ar) acute leukemia.
Brand Name : SNDX-5613
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 29, 2024
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Darunavir,Cobicistat
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
J&J seeks expanded approvals for paediatric HIV-1 therapy
Details : Filed a sNDA with the USFDA seeking expanded approval for the use of its HIV-1 therapy, PREZCOBIX (darunavir/cobicistat), in children aged six years and above, weighing at least 25kg.
Brand Name : Prezcobix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 05, 2024
Lead Product(s) : Darunavir,Cobicistat
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Syndax Completes Enrollment in AUGMENT-101 Trial of Relapsed/Refractory AML
Details : SNDX-5613 (revumenib) is a highly selective, first-in-class oral menin inhibitor, for the treatment of Relapsed/Refractory mNPM1 Acute Myeloid Leukemia.
Brand Name : SNDX-5613
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 28, 2024
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Syndax Announces FDA Priority Review of NDA for Revumenib in R/R Acute Leukemia
Details : SNDX-5613 (revumenib) is a highly selective, first-in-class oral menin inhibitor, for the treatment of adult and pediatric patients with relapsed or refractory KMT2A-rearranged acute leukemia.
Brand Name : SNDX-5613
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 26, 2024
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Revumenib is a potent, selective, small molecule inhibitor of the menin-KMT2A binding interaction that is being developed for the treatment of KMT2A-rearranged, also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including ALL and AM...
Brand Name : SNDX-5613
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 24, 2023
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : SNDX-5613 (revumenib) is an investigational, novel, orally available Menin-MLL1 inhibitor, which is investigated for the treatment of R/R KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL).
Brand Name : SNDX-5613
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 02, 2023
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : SNDX-5613 (revumenib) is an investigational, novel, orally available Menin-MLL1 inhibitor, which is investigated for the treatment of relapsed/refractory KMT2Ar acute leukemia.
Brand Name : SNDX-5613
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 29, 2023
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Plixorafenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF, it is being investogated for the treatment of primary brain and central nervous system (CNS) malignancies.
Brand Name : FORE8394
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 20, 2023
Lead Product(s) : Plixorafenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Plixorafenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : FORE8394 is a selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF. It is being developed for BRAF-mutated solid and brain tumors.
Brand Name : FORE8394
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 23, 2023
Lead Product(s) : Plixorafenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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