Mesoblast spins a PhIII cell therapy miss in heart failure as a win, highlighting positive mortality data
About two and a half months after the FDA turned away their lead program, Mesoblast $MESO reported a Phase III miss Monday afternoon for their second clinical product. But the Australian biotech pointed toward data in a secondary endpoint it thinks the agency might find promising.
In a late-stage trial measuring rexlemestrocel-L in 537 patients, Mesoblast found that the experimental cell therapy did not significantly reduce hospitalizations over placebo in individuals with recurring heart failure. The program managed to hit secondaries in mortality-rate reduction for earlier stages of heart failure, and it’s here where Mesoblast hopes it can still pave a path toward accelerated approval should regulators prove receptive.
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