secwatch.observer — SEC 8-K summary
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Issuer:     Unicycive Therapeutics, Inc. (UNCY)
CIK:        0001766140
Form:       8-K
Filed at:   2025-10-28T23:59:59+00:00
Accession:  0001213900-25-102790
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Unicycive expects to resubmit OLC NDA by year-end after constructive FDA Type A meeting; cash $42M
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- Cash and cash equivalents ~$42M as of Sept 30, 2025; runway into 2027 supports NDA resubmission, potential FDA approval, and launch.
- FDA Type A meeting resolved single CRL deficiency re: third-party manufacturing vendor compliance; no other concerns identified.
- Company plans to resubmit NDA for Oxylanthanum Carbonate (OLC) before year-end; potential PDUFA date in H1 2026.
- FDA confirmed no issues with pre-clinical, clinical, or safety data submitted in original NDA.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1766140/000121390025102790/0001213900-25-102790-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1766140/000121390025102790/ea0262723-8k_unicycive.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-102790

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