secwatch.observer — SEC 8-K summary
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Issuer:     Unicycive Therapeutics, Inc. (UNCY)
CIK:        0001766140
Form:       8-K
Filed at:   2023-10-23T23:59:59+00:00
Accession:  0001013762-23-005659
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Unicycive reaches FDA alignment on NDA path for OLC; pivotal trial to start by end of 2023
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- FDA agreed on full NDA package requirements: clinical, preclinical, and CMC data for Oxylanthanum Carbonate (OLC).
- Pivotal open-label trial to enroll 60 CKD dialysis patients; 4-week evaluation after dose titration.
- Top-line data expected Q2 2024; no statistical analysis required; efficacy referenced from prior bioequivalence study.
- Cash of $18.8M as of June 30, 2023 expected to fund trial and operations into H2 2024.
- NDA to be filed via 505(b)(2) pathway referencing Fosrenol; only one clinical study required.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1766140/000101376223005659/0001013762-23-005659-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1766140/000101376223005659/ea187125-8k_unicycive.htm
  HTML page:      https://secwatch.observer/filing/0001013762-23-005659

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