secwatch.observer — SEC 8-K summary
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Issuer:     REVIVA PHARMACEUTICALS HOLDINGS, INC. (RVPH)
CIK:        0001742927
Form:       8-K
Filed at:   2024-04-15T23:59:59+00:00
Accession:  0001437749-24-012074
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Reviva gains FDA alignment on Phase 3 RECOVER-2 study for brilaroxazine in schizophrenia
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- FDA accepts 4-week RECOVER-2 study; two positive Phase 3 studies plus 12-month safety could support NDA.
- Topline data from 1-year OLE long-term safety trial expected Q4 2024; NDA submission targeted by Q3 2025.
- RECOVER-2 is a 450-patient global Phase 3 trial; primary endpoint is PANSS total score change at Day 28.
- Company plans to initiate first clinical site in Q2 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1742927/000143774924012074/0001437749-24-012074-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1742927/000143774924012074/rvph20240415_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-012074

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