secwatch.observer — SEC 8-K summary
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Issuer:     PROKIDNEY CORP. (PROK)
CIK:        0001850270
Form:       8-K
Filed at:   2026-02-02T23:59:59+00:00
Accession:  0001193125-26-033594
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

ProKidney updates PROACT 1 enrollment target to ~470; confirmatory readout now H2 2029
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- Enrollment target increased to ~470 subjects in Phase 3 PROACT 1 (REGEN-006) study.
- Surrogate endpoint (eGFR slope) topline data readout still anticipated Q2 2027.
- Confirmatory endpoint (composite time-to-event) topline data readout now anticipated H2 2029.
- Statistical powering assumptions unchanged for both surrogate and confirmatory analyses.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1850270/000119312526033594/0001193125-26-033594-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1850270/000119312526033594/prok-20260202.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-033594

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer