secwatch.observer — SEC 8-K summary
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Issuer:     Unicycive Therapeutics, Inc. (UNCY)
CIK:        0001766140
Form:       8-K
Filed at:   2024-11-12T23:59:59+00:00
Accession:  0001213900-24-096104
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Unicycive's NDA for Oxylanthanum Carbonate; PDUFA date June 28, 2025
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- FDA accepted NDA for OLC to treat hyperphosphatemia in CKD patients on dialysis.
- PDUFA target action date set for June 28, 2025; company preparing for commercial launch in H2 2025.
- FDA granted a waiver for the NDA application PDUFA fees, saving approximately $4 million.
- OLC aims to reduce pill burden vs. current options (up to 12 pills/day); pills are swallowed, not chewed.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1766140/000121390024096104/0001213900-24-096104-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1766140/000121390024096104/ea0220621-8k_unicycive.htm
  HTML page:      https://secwatch.observer/filing/0001213900-24-096104

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