---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-053035"
form_type: "8-K"
ticker: "UNCY"
cik: "0001766140"
company_name: "Unicycive Therapeutics, Inc."
filed_at: "2023-06-30T23:59:59+00:00"
generated_at: "2026-06-13T14:12:42.183402+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Unicycive receives FDA request for additional data on LDC NDA; timeline extended

## Summary
- FDA asked for risk assessment and clinical data to evaluate tolerability of lanthanum dioxycarbonate in dialysis patients.
- Pre-NDA meeting revealed quantitative differences in GI adverse findings between LDC and lanthanum carbonate.
- Company plans follow-up meeting with FDA and expects further updates in Q3 2023.
- Bioequivalence to Fosrenol was previously established in Phase I studies; no GI neoplasms seen in mouse study.
- LDC targets hyperphosphatemia in CKD dialysis patients; global market opportunity >$2.5B in 2023.

## SEC filing metadata
- accession: 0001213900-23-053035
- form_type: 8-K
- ticker: UNCY
- cik: 0001766140
- company_name: Unicycive Therapeutics, Inc.
- filed_at: 2023-06-30T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1766140/000121390023053035/0001213900-23-053035-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1766140/000121390023053035/ea181168-8k_unicycive.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-053035
- JSON: https://secwatch.observer/filing/0001213900-23-053035.json
- Plain text: https://secwatch.observer/filing/0001213900-23-053035.txt

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