---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-104314"
form_type: "8-K"
ticker: "UNCY"
cik: "0001766140"
company_name: "Unicycive Therapeutics, Inc."
filed_at: "2026-09-29T11:46:32+00:00"
generated_at: "2026-10-12T13:42:11.182072+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Unicycive resubmits OLC NDA with new CMC vendor; PDUFA expected 6 months after Sept 29, 2026 filing

## Summary
- Resubmission includes CMC data and 12-month stability data from a new third-party drug product manufacturer; FDA acceptance expected within 30 days.
- New vendor's facility received FDA 'No Action Indicated' status after a March 2024 inspection; both vendors will be kept for supply chain redundancy.
- The June 2026 CRL cited the same third-party manufacturing deficiencies as the June 2025 CRL; FDA did not raise clinical efficacy or safety concerns.
- Meredith S. Manning was appointed an independent director effective Oct 1, 2026, and will chair the Nominating and Corporate Governance Committee.
- Unaudited cash, cash equivalents and marketable securities totaled $61.4 million as of June 30, 2026, funding runway into 2H 2027.

## SEC filing metadata
- accession: 0001213900-26-104314
- form_type: 8-K
- ticker: UNCY
- cik: 0001766140
- company_name: Unicycive Therapeutics, Inc.
- filed_at: 2026-09-29T11:46:32+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 5.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1766140/000121390026104314/0001213900-26-104314-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1766140/000121390026104314/ea0306967-8k_unicycive.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-104314
- JSON: https://secwatch.observer/filing/0001213900-26-104314.json
- Plain text: https://secwatch.observer/filing/0001213900-26-104314.txt

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