普通外文研报
PROK: 1Q26 Earnings In Line; Pivotal PROACT 1 Study Remains On Track for Primary eGFR Slope Data Analysis in 2Q 2027; Reiterate Buy Rating
研报英文原文证据摘录
PROK: 1Q26 Earnings In Line; Pivotal PROACT 1 Study Remains On Track for Primary eGFR Slope Data Analysis in 2Q 2027; Reiterate Buy Rating
May 18, 2026
Vamil Divan, M.D. vamil.divan@guggenheimpartners.com PROK: 1Q26 Earnings In Line; Pivotal PROACT 1
212 823 6543 Study Remains On Track for Primary eGFR Slope
Edouard Mullarky, Ph.D.
edouard.mullarky@guggenheimpartners.com Data Analysis in 2Q 2027; Reiterate Buy Rating
212 518 9579
Arseniy Shabashvili Key Message: PROK reported 1Q 2026 results and provided a corporate update late arseniy.shabashvili@guggenheimpartners.com last week. 1Q 2026 results included an EPS loss of ($0.14) versus our estimate of an 212 699 1971
EPS loss of ($0.16). Most importantly, Phase 3 enrollment for the pivotal rilparencel study
Daniel Krizay, Ph.D. remains on track, with PROK still anticipating enrollment for the eGFR slope analysis set
daniel.krizay@guggenheimpartners.com of patients to be completed by mid-2026, paving the way for topline eGFR slope results
212 823 6561 in 2Q 2027. We caught up with the management team following the earnings release,
and they explained that an increase in the number of discontinuations in the trial (mainly
in patients following study randomization but before they received either rilparencel or
the sham kidney biopsy) will lower the number of patients in the accelerated eGFR slope
analysis to 320 (from 360 before). However, the study retains 80% power to detect anPROK BUY effect size of 1.5 mL/min/1.73m² in annualized eGFR slope, and 90% power to detect an ProKidney Corp.
Sector: Biotechnology effect size of 1.75 mL/min/1.73m² in annualized eGFR slope. The company also noted
that under rilparencel’s regenerative medicine advanced therapy (RMAT) designation,
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