secwatch.observer — SEC 8-K summary
======================================

Issuer:     REVIVA PHARMACEUTICALS HOLDINGS, INC. (RVPH)
CIK:        0001742927
Form:       8-K
Filed at:   2024-12-16T23:59:59+00:00
Accession:  0001437749-24-037520
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Reviva reports positive preliminary 1-year OLE data for brilaroxazine in schizophrenia
--------------------------------------------------------------------------------

- 435 patients enrolled in OLE; 113 completed 52 weeks; pooled PANSS total decreased 18.6 points (p≤0.0001).
- Dose-dependent efficacy: PANSS total decreases of -15.2, -18.6, -20.8 for 15, 30, 50 mg doses.
- Safety: 15.2% TRAE, mostly mild; no drug-related SAEs; discontinuation rate 35%, primarily withdrawal of consent (22%).
- Long-term safety data from 100+ patients meets FDA NDA submission requirement; full OLE data expected Q1 2025.
- Brilaroxazine generally well-tolerated with no single side effect >5%; no clinically meaningful movement disorder changes.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1742927/000143774924037520/0001437749-24-037520-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1742927/000143774924037520/rvph20241215_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-037520

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