---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-052824"
form_type: "8-K"
ticker: "UNCY"
cik: "0001766140"
company_name: "Unicycive Therapeutics, Inc."
filed_at: "2025-06-10T23:59:59+00:00"
generated_at: "2026-05-19T15:56:40.688637+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Unicycive FDA update: cGMP deficiencies at OLC manufacturing subcontractor; PDUFA June 28

## Summary
- FDA identified cGMP deficiencies at a third-party manufacturing subcontractor (not drug substance vendor) for oxylanthanum carbonate.
- Label discussions precluded due to deficiencies; company has responded to all FDA information requests.
- Final FDA decision expected by PDUFA action date of June 28, 2025.
- Company is working with partners to resolve FDA concerns.
- CEO expresses confidence in OLC based on clinical and preclinical data.

## SEC filing metadata
- accession: 0001213900-25-052824
- form_type: 8-K
- ticker: UNCY
- cik: 0001766140
- company_name: Unicycive Therapeutics, Inc.
- filed_at: 2025-06-10T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1766140/000121390025052824/0001213900-25-052824-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1766140/000121390025052824/ea0245246-8k_unicycive.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-052824
- JSON: https://secwatch.observer/filing/0001213900-25-052824.json
- Plain text: https://secwatch.observer/filing/0001213900-25-052824.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.