NEW YORK – Relay Therapeutics and Elevar Therapeutics on Wednesday announced an exclusive global licensing agreement for lirafugratinib (RLY-4008) in FGFR2-driven cancers.
NCI will include the multi-kinase inhibitor in the umbrella trial evaluating targeted therapy combinations in AML and MDS patients.
CMS has negotiated outcomes-based agreements for sickle cell gene therapies with the two companies on behalf of participating state Medicaid programs.
In recommending Kimmtrak, NICE factored in a new commercial agreement with the sponsor and changed its 2023 negative opinion.
In the study, the firm will enroll previously treated patients whose tumors are positive for FRα based on IHC testing.
Novartis licensed PTC's PTC518 Huntington's disease program and related molecules and will pay $1 billion upfront as well as other costs.
The trials are evaluating an individualized neoantigen vaccine with Keytruda as an adjuvant therapy for non-small cell lung cancer.
The firm plans to put the proceeds toward further developing its cell therapy in CD33- or FLT3-expressing AML and for other R&D activities.
The agency is also evaluating if there's a need for further regulatory action based on reports of hematologic malignancies from clinical trials of the therapy.
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The firm is engaging with regulators about its recently validated Ataraxis Breast test, which it hopes to make available for clinical use next year.
The global Phase III VANCE trial of the autologous EBV-targeted T-cell therapy was the largest trial of a solid tumor cell ...