---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-24-055436"
form_type: "8-K"
ticker: "UNCY"
cik: "0001766140"
company_name: "Unicycive Therapeutics, Inc."
filed_at: "2024-06-25T23:59:59+00:00"
generated_at: "2026-06-01T02:14:13.170212+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Unicycive OLC pivotal trial meets primary endpoint; NDA submission planned Q3 2024

## Summary
- Primary endpoint achieved: only 1.4% treatment-related discontinuation in evaluable population (n=71), vs 14% for Fosrenol.
- Secondary safety endpoint: no treatment-related SAEs; most AEs mild-moderate; diarrhea (9%) and vomiting (6%) most common.
- After washout, 90% of safety population (77/86) achieved phosphate ≤5.5 mg/dL at end of titration with OLC.
- NDA submission via 505(b)(2) pathway anticipated Q3 2024, supported by bioequivalence and preclinical data.
- Study enrolled 106 patients; OLC demonstrated tolerability at clinically effective doses (up to 3000 mg/day).

## SEC filing metadata
- accession: 0001213900-24-055436
- form_type: 8-K
- ticker: UNCY
- cik: 0001766140
- company_name: Unicycive Therapeutics, Inc.
- filed_at: 2024-06-25T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1766140/000121390024055436/0001213900-24-055436-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1766140/000121390024055436/ea0208437-8k_unicycive.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-055436
- JSON: https://secwatch.observer/filing/0001213900-24-055436.json
- Plain text: https://secwatch.observer/filing/0001213900-24-055436.txt

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