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 : 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
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Goldman Sachs & Co.
Deal Size : $172.5 million
Deal Type : Public Offering
Details : SNDX-5613 (revumenib) is an investigational, novel, orally available Menin-MLL1 inhibitor. The interaction of Menin and MLL1 has been demonstrated to play an essential role in the leukemic transformation for acute leukemia patients with MLLr or NPM1 muta...
Brand Name : SNDX-5613
Molecule Type : Small molecule
Upfront Cash : Undisclosed
December 14, 2022
Lead Product(s) : Revumenib,Cobicistat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Goldman Sachs & Co.
Deal Size : $172.5 million
Deal Type : Public Offering
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