Keeping Track: The Breakthrough Designations Of Summer Eschew Phase I
The latest breakthrough therapy designation announcements from the Pink Sheet’s US FDA Performance Tracker
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Takeda is confident about the promise of its first-in-class molecule for higher-risk myelodysplastic syndromes after positive Phase II data.
The Phase III EXPLORER-HCM trial evaluating mavacamten in obstructive hypertrophic cardiomyopathy (oHCM) succeeded on all primary and secondary endpoints.
Pink Sheet analysis finds that evidence from early-stage trials supports most BTD requests, but about three in 10 designations are granted on the basis of pivotal-stage data.