---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-059303"
form_type: "8-K"
ticker: "UNCY"
cik: "0001766140"
company_name: "Unicycive Therapeutics, Inc."
filed_at: "2025-06-30T23:59:59+00:00"
generated_at: "2026-05-18T13:47:46.018436+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for Unicycive's oxylanthanum carbonate NDA; company plans Type A meeting

## Summary
- CRL cites deficiencies at third-party manufacturing vendor unrelated to OLC drug; no clinical or safety concerns.
- Second manufacturing vendor already produced OLC drug product; may resolve CMC issues identified in CRL.
- Unicycive plans to immediately request a Type A meeting with FDA to align on next steps.
- Preliminary unaudited cash ~$20.7M as of June 30, 2025; cash runway expected into H2 2026.

## SEC filing metadata
- accession: 0001213900-25-059303
- form_type: 8-K
- ticker: UNCY
- cik: 0001766140
- company_name: Unicycive Therapeutics, Inc.
- filed_at: 2025-06-30T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1766140/000121390025059303/0001213900-25-059303-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1766140/000121390025059303/ea0247469-8k_unicycive.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-059303
- JSON: https://secwatch.observer/filing/0001213900-25-059303.json
- Plain text: https://secwatch.observer/filing/0001213900-25-059303.txt

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