---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-24-096104"
form_type: "8-K"
ticker: "UNCY"
cik: "0001766140"
company_name: "Unicycive Therapeutics, Inc."
filed_at: "2024-11-12T23:59:59+00:00"
generated_at: "2026-05-30T02:04:54.757987+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Unicycive's NDA for Oxylanthanum Carbonate; PDUFA date June 28, 2025

## Summary
- FDA accepted NDA for OLC to treat hyperphosphatemia in CKD patients on dialysis.
- PDUFA target action date set for June 28, 2025; company preparing for commercial launch in H2 2025.
- FDA granted a waiver for the NDA application PDUFA fees, saving approximately $4 million.
- OLC aims to reduce pill burden vs. current options (up to 12 pills/day); pills are swallowed, not chewed.

## SEC filing metadata
- accession: 0001213900-24-096104
- form_type: 8-K
- ticker: UNCY
- cik: 0001766140
- company_name: Unicycive Therapeutics, Inc.
- filed_at: 2024-11-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1766140/000121390024096104/0001213900-24-096104-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1766140/000121390024096104/ea0220621-8k_unicycive.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-096104
- JSON: https://secwatch.observer/filing/0001213900-24-096104.json
- Plain text: https://secwatch.observer/filing/0001213900-24-096104.txt

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