The newly formed SAB will provide strategic direction across research, clinical development, and regulatory pathways
SBE303 targets Nectin-4, an adhesion protein overexpressed in multiple tumor types, including urothelial, lung, and breast cancers
Narasimhan’s appointment underscores the growing importance of AI in transforming drug discovery
ENFLONSIA is a long-acting monoclonal antibody designed to shield infants through a typical five-month RSV season with a single, fixed dose
The upcoming multi-center, multinational Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy
The goal is to better support drug developers as programs move from laboratory research into clinical trials
The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck
The companies plan to advance multiple solid tumor targets from Regeneron’s antibody portfolio
The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis
The results were consistent across both the 10 mg and 40 mg treatment arms
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