secwatch.observer — SEC 8-K summary
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Issuer:     Unicycive Therapeutics, Inc. (UNCY)
CIK:        0001766140
Form:       8-K
Filed at:   2025-06-30T23:59:59+00:00
Accession:  0001213900-25-059303
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA issues Complete Response Letter for Unicycive's oxylanthanum carbonate NDA; company plans Type A meeting
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- CRL cites deficiencies at third-party manufacturing vendor unrelated to OLC drug; no clinical or safety concerns.
- Second manufacturing vendor already produced OLC drug product; may resolve CMC issues identified in CRL.
- Unicycive plans to immediately request a Type A meeting with FDA to align on next steps.
- Preliminary unaudited cash ~$20.7M as of June 30, 2025; cash runway expected into H2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1766140/000121390025059303/0001213900-25-059303-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1766140/000121390025059303/ea0247469-8k_unicycive.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-059303

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer