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FDA has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's recently FDA-approved hemophilia B gene therapy.
Lead Product(s): Fidanacogene elaparvovec
Therapeutic Area: Genetic Disease Product Name: Beqvez
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2024
Details:
Through the collaboration, Labcorp and Xcellbio will work on a series of projects focused on improving the safety and efficacy of cell and gene therapies (CGTs). s. The projects included in the collaboration will use Xcellbio’s AVATAR incubator system to grow.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Xcell Biosciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 19, 2022
Details:
Using the lung biopsy specimen, the assay identifies whether a patient with NSCLC has a specific mutation in the KRAS gene and is eligible for treatment with LUMAKRAS™ (sotorasib) which was developed by Amgen.
Lead Product(s): Sotorasib
Therapeutic Area: Oncology Product Name: Lumakras
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2021
Details:
The proceeds from this financing will support expansion of Presage's existing network of clinical sites in the U.S. and Australia, as well as development of next-generation CIVO microdose injection devices designed to access a wider spectrum of cancers.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Undisclosed
Recipient: Presage Biosciences
Deal Size: $13.0 million Upfront Cash: Undisclosed
Deal Type: Financing March 02, 2021
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