secwatch.observer — SEC 8-K summary
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Issuer:     PROKIDNEY CORP. (PROK)
CIK:        0001850270
Form:       8-K
Filed at:   2024-06-10T23:59:59+00:00
Accession:  0001193125-24-157913
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

ProKidney reports REGEN-007 Phase 2 interim: eGFR stable over 18 months; manufacturing resumed
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- In Group 1 (n=13), average eGFR change from baseline was -1.3 ml/min/1.73m² at 18 months; subset meeting Phase 3 criteria (n=10) showed -0.6.
- No rilparencel-related serious adverse events in any of the 49 patients who received at least one injection.
- Manufacturing resumed effective June 1, 2024 for U.S. and non-European clinical sites.
- Anticipates QP Declaration of Equivalence to EU GMPs by end of June 2024 to enable European shipments.
- PROACT 1 screening resumed under amended protocol enriched for higher risk patients; PROACT 2 activated sites in Spain.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1850270/000119312524157913/0001193125-24-157913-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1850270/000119312524157913/d827829d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-157913

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