Accelerated Regulatory PathwayTargeting a surrogate kidney function endpoint creates a clear path for an accelerated regulatory filing that could enable earlier market approval if surrogate results meet agency standards.
Enrollment Momentum And Financial RunwayStrong patient enrollment momentum combined with reiterated cash runway supports timely study execution and allows greater focus on commercial readiness for a potential launch.
Statistical Integrity Of Pivotal TrialMaintained statistical power and preserved the planned number of confirmatory events support the trial's ability to detect meaningful treatment effects, reinforcing confidence in study validity.