---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-037520"
form_type: "8-K"
ticker: "RVPH"
cik: "0001742927"
company_name: "REVIVA PHARMACEUTICALS HOLDINGS, INC."
filed_at: "2024-12-16T23:59:59+00:00"
generated_at: "2026-05-29T03:02:11.320823+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-24-037520
- form_type: 8-K
- ticker: RVPH
- cik: 0001742927
- company_name: REVIVA PHARMACEUTICALS HOLDINGS, INC.
- filed_at: 2024-12-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1742927/000143774924037520/0001437749-24-037520-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1742927/000143774924037520/rvph20241215_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-037520
- JSON: https://secwatch.observer/filing/0001437749-24-037520.json
- Plain text: https://secwatch.observer/filing/0001437749-24-037520.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.