---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-102790"
form_type: "8-K"
ticker: "UNCY"
cik: "0001766140"
company_name: "Unicycive Therapeutics, Inc."
filed_at: "2025-10-28T23:59:59+00:00"
generated_at: "2026-05-17T01:58:04.131015+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Unicycive expects to resubmit OLC NDA by year-end after constructive FDA Type A meeting; cash $42M

## Summary
- Cash and cash equivalents ~$42M as of Sept 30, 2025; runway into 2027 supports NDA resubmission, potential FDA approval, and launch.
- FDA Type A meeting resolved single CRL deficiency re: third-party manufacturing vendor compliance; no other concerns identified.
- Company plans to resubmit NDA for Oxylanthanum Carbonate (OLC) before year-end; potential PDUFA date in H1 2026.
- FDA confirmed no issues with pre-clinical, clinical, or safety data submitted in original NDA.

## SEC filing metadata
- accession: 0001213900-25-102790
- form_type: 8-K
- ticker: UNCY
- cik: 0001766140
- company_name: Unicycive Therapeutics, Inc.
- filed_at: 2025-10-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1766140/000121390025102790/0001213900-25-102790-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1766140/000121390025102790/ea0262723-8k_unicycive.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-102790
- JSON: https://secwatch.observer/filing/0001213900-25-102790.json
- Plain text: https://secwatch.observer/filing/0001213900-25-102790.txt

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