Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Darunavir,Cobicistat,Emtricitabine
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Receives Tentative FDA Approval for Generic Darunavir Combination Tablets
Details : Symtuza-Generic (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) is an FDC product which is indicated for the treatment of HIV-1 infection in adults and pediatric patients.
Product Name : Symtuza-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 05, 2025
Lead Product(s) : Darunavir,Cobicistat,Emtricitabine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Syndax Reports Positive Data for Revuforj® in Relapsed/Refractory mNPM1 AML
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.
Product Name : Revuforj
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 09, 2024
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SNDX-5613
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 15, 2024
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SNDX-5613
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 29, 2024
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Darunavir,Cobicistat
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Prezcobix
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 06, 2024
Lead Product(s) : Darunavir,Cobicistat
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SNDX-5613
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 28, 2024
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SNDX-5613
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 26, 2024
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : SNDX-5613
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 24, 2023
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SNDX-5613
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 29, 2023
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Plixorafenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : FORE8394
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 20, 2023
Lead Product(s) : Plixorafenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable