secwatch.observer — SEC 8-K summary
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Issuer:     Unicycive Therapeutics, Inc. (UNCY)
CIK:        0001766140
Form:       8-K
Filed at:   2026-09-29T11:46:32+00:00
Accession:  0001213900-26-104314
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 5.02, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1766140/000121390026104314/0001213900-26-104314-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1766140/000121390026104314/ea0306967-8k_unicycive.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-104314

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