The collaboration aims to combine synthetic biology with cutting-edge detection technology to create a first-of-its-kind oral pill embedded with tumor-targeting sensors
The drug had previously received orphan drug designation for this rare cancer on March 31, 2025
The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies
The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers
Full approval will depend on verification of clinical benefit in a confirmatory trial
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity
Healthcare and insurance are not parallel systems; they are interdependent pillars of patient trust
FOP is a rare genetic disorder caused by mutations in the ALK2 kinase
The company also reported significant progress toward its internally defined Sustainable Development Goals
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