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0 0 0.0242572758060519 0.0242572758060519 -0.00602990170434209 -0.0968363666400507 -0.103774883669705 -0.132685371293262
Stock impact report

Reviva Announces FDA Alignment on Brilaroxazine Clinical Trials for NDA in Schizophrenia [Yahoo! Finance]

Reviva Pharmaceuticals Holdings, Inc. (RVPH) 
Company Research Source: Yahoo! Finance
- Two positive 4-week studies plus a 12-month long-term safety study have potential to support a New Drug Application (NDA) for brilaroxazine in schizophrenia – - Topline data from 1-year open-label extension (OLE) long-term safety trial expected in Q4 2024 - CUPERTINO, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, announced today it has gained alignment with the U.S. Food and Drug Administration (FDA) on its registrational Phase 3 program for brilaroxazine in schizophrenia. The FDA accepted a 4-week RECOVER-2 study for brilaroxazine in schizophrenia. Notably, the FDA also indicated that two positive Phase 3 studies showing efficacy at week 4 that are accompanied by long-term safety data of at least 12 months could be supportive of an NDA submi Show less Read more
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