Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Taletrectinib
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Nuvation Bio to Head to FDA with Pooled ROS1-Positive Lung Cancer Data
Details : AB-106 (taletrectinib) is a next-generation ROS1 TKI, which is being evaluated for the treatment of adult patients with locally advanced or metastatic NSCLC.
Brand Name : AB-106
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 14, 2024
Lead Product(s) : Taletrectinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Taletrectinib
Therapeutic Area : Oncology
Study Phase : Phase II
Recipient : AnHeart Therapeutics
Deal Size : Undisclosed
Deal Type : Acquisition
Nuvation Bio Completes Acquisition of AnHeart Therapeutics
Details : The acquisition adds AnHeart’s AB-106, a next-generation ROS1 inhibitor with Breakthrough Therapy Designations, currently completing two pivotal studies for ROS1-positive non-small cell lung cancer.
Brand Name : AB-106
Molecule Type : Small molecule
Upfront Cash : Undisclosed
April 10, 2024
Lead Product(s) : Taletrectinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : AnHeart Therapeutics
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Taletrectinib
Therapeutic Area : Oncology
Study Phase : Phase II
Recipient : AnHeart Therapeutics
Deal Size : Undisclosed
Deal Type : Acquisition
Nuvation Bio to Acquire AnHeart Therapeutics in All-Stock Transaction
Details : The acquisition adds AnHeart’s AB-106, a next-generation ROS1 inhibitor with Breakthrough Therapy Designations, currently completing two pivotal studies for ROS1-positive non-small cell lung cancer.
Brand Name : AB-106
Molecule Type : Small molecule
Upfront Cash : Undisclosed
March 25, 2024
Lead Product(s) : Taletrectinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : AnHeart Therapeutics
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : NUV-1511
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Nuvation Bio Doses First Patient in Phase 1/2 Study Of NUV-1511
Details : NUV-1511 is the first clinical DDC platform candidate for advanced solid tumors, including HER2-negative metastatic breast cancer and metastatic castration-resistant prostate cancer.
Brand Name : NUV-1511
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 14, 2024
Lead Product(s) : NUV-1511
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : NUV-1511
Therapeutic Area : Oncology
Study Phase : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Nuvation Bio Gets FDA Clearance for IND Application for NUV-1511 in Advanced Solid Tumors
Details : NUV-1511 is the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform. It is being evaluated in preclinical studies for the treatment of advanced solid tumors.
Brand Name : NUV-1511
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 08, 2024
Lead Product(s) : NUV-1511
Therapeutic Area : Oncology
Highest Development Status : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : NUV-868,Olaparib
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Nuvation Bio Doses First Patient in Phase 1b Combination Study of NUV-868
Details : Patients in the first regimen will be dosed with NUV-868 in combination with olaparib for the treatment of ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors.
Brand Name : NUV-868
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 19, 2022
Lead Product(s) : NUV-868,Olaparib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : NUV-422,Enzalutamide
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Nuvation Bio Announces Discontinuation of NUV-422 Clinical Development Program
Details : Decision to discontinue development of NUV-422 is result of an internal risk-benefit analysis factoring in feedback received from U.S. FDA in partial clinical hold letter for monotherapy Phase 1/2 study and clinical hold letters for its combination Phase...
Brand Name : NUV-422
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 01, 2022
Lead Product(s) : NUV-422,Enzalutamide
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : NUV-422
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Nuvation Bio Announces FDA Partial Clinical Hold for Phase 1 Study of NUV-422 in Solid Tumors
Details : Preclinical studies have shown that NUV-422 has favorable blood-brain barrier penetration. NUV-422 is also designed to limit CDK1 inhibition, a potential cause of toxicity in other second-generation inhibitors.
Brand Name : NUV-422
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 24, 2022
Lead Product(s) : NUV-422
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : NUV-422
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Nuvation Bio Provides Corporate Update and Highlights Key 2022 Milestones
Details : NUV-422, a selective small-molecule cyclin-dependent kinase (CDK) 2/4/6 inhibitor, has also received ODD for the treatment of patients with malignant gliomas and FTD for the treatment of high-grade gliomas from USFDA.
Brand Name : NUV-422
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 10, 2022
Lead Product(s) : NUV-422
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : NUV-422
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Company announced that the USFDA has granted FTD to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with high-grade gliomas, including glioblastoma multiforme.
Brand Name : NUV-422
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 15, 2021
Lead Product(s) : NUV-422
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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