Mesoblast (MESO) said late Tuesday the US Food and Drug Administration granted an investigational new drug clearance, enabling the company to directly proceed to a registrational clinical trial evaluating Ryoncil in Duchenne muscular dystrophy, a genetic disorder.
The trial will randomize 76 patients aged five to nine years to either Ryoncil or placebo, plus standard of care.
The company said the primary endpoint will be time-to-stand at nine months, a validated FDA endpoint for approval.
Mesoblast shares were up 5.4% in premarket activity Wednesday.
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