secwatch.observer — SEC 8-K summary
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Issuer:     Unicycive Therapeutics, Inc. (UNCY)
CIK:        0001766140
Form:       8-K
Filed at:   2025-06-10T23:59:59+00:00
Accession:  0001213900-25-052824
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Unicycive FDA update: cGMP deficiencies at OLC manufacturing subcontractor; PDUFA June 28
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- FDA identified cGMP deficiencies at a third-party manufacturing subcontractor (not drug substance vendor) for oxylanthanum carbonate.
- Label discussions precluded due to deficiencies; company has responded to all FDA information requests.
- Final FDA decision expected by PDUFA action date of June 28, 2025.
- Company is working with partners to resolve FDA concerns.
- CEO expresses confidence in OLC based on clinical and preclinical data.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1766140/000121390025052824/0001213900-25-052824-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1766140/000121390025052824/ea0245246-8k_unicycive.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-052824

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