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

Issuer:     REVIVA PHARMACEUTICALS HOLDINGS, INC. (RVPH)
CIK:        0001742927
Form:       8-K
Filed at:   2025-06-02T23:59:59+00:00
Accession:  0001437749-25-019062
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Reviva reports positive full dataset from Phase 3 OLE study of brilaroxazine in schizophrenia
--------------------------------------------------------------------------------

- Brilaroxazine showed sustained efficacy across all symptom domains: PANSS total score improved -18.1 at 12 months (p≤0.001).
- Safety profile well-tolerated: 8.5% TEAEs mostly mild, no drug-related SAEs; discontinuation rate 35%.
- Mild weight gain (1.52 kg) and no clinically significant cardiac, liver, or metabolic side effects.
- Long-term safety data from 100 patients completing 1 year meets NDA submission requirement for FDA.
- Improved multiple neuroinflammatory biomarkers; virtual webcast held June 2, 2025 at 8:00 a.m. EDT.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1742927/000143774925019062/0001437749-25-019062-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1742927/000143774925019062/rvph20250601_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-019062

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