secwatch.observer — SEC 8-K summary
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Issuer:     Unicycive Therapeutics, Inc. (UNCY)
CIK:        0001766140
Form:       8-K
Filed at:   2024-06-25T23:59:59+00:00
Accession:  0001213900-24-055436
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Unicycive OLC pivotal trial meets primary endpoint; NDA submission planned Q3 2024
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- Primary endpoint achieved: only 1.4% treatment-related discontinuation in evaluable population (n=71), vs 14% for Fosrenol.
- Secondary safety endpoint: no treatment-related SAEs; most AEs mild-moderate; diarrhea (9%) and vomiting (6%) most common.
- After washout, 90% of safety population (77/86) achieved phosphate ≤5.5 mg/dL at end of titration with OLC.
- NDA submission via 505(b)(2) pathway anticipated Q3 2024, supported by bioequivalence and preclinical data.
- Study enrolled 106 patients; OLC demonstrated tolerability at clinically effective doses (up to 3000 mg/day).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1766140/000121390024055436/0001213900-24-055436-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1766140/000121390024055436/ea0208437-8k_unicycive.htm
  HTML page:      https://secwatch.observer/filing/0001213900-24-055436

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