Reviva Provides Corporate and Program Updates and Highlights Key Upcoming Milestones

– Schizophrenia late-stage clinical program advances with positive topline Phase 3 data, successful ongoing enrollment in open label extension (OLE) trial, and positive drug-drug interaction data supporting a differentiated profile for once-daily brilaroxazine –

– Initiation of registrational Phase 3 RECOVER-2 trial expected Q1 2024 –

– Topline data from 1-year OLE trial expected Q4 2024 –

CUPERTINO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), 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, today provided program updates and announced upcoming key milestones.

“In 2023, we made significant progress across our late-stage brilaroxazine clinical program in schizophrenia, including positive topline Phase 3 data demonstrating statistically significant reductions across all major symptom domains, successful ongoing enrollment in our one-year OLE trial, and positive clinical drug-drug interaction data supporting a competitive profile for once-daily brilaroxazine,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “We also furthered foundational preclinical support for the therapeutic potential of brilaroxazine in other inflammatory conditions driven by underlying serotonin signaling dysfunction, including psoriasis and idiopathic pulmonary fibrosis (IPF). We believe these advances reinforce the broad potential of brilaroxazine to be a safe and effective therapy for major neuropsychiatric and inflammatory indications caused by a dysfunctional serotonin-dopamine system. Importantly, our recent progress brings us closer than ever to fulfilling our mission of reviving the full promise of patients’ lives with treatment paradigm changing drugs targeting neurotransmitter-driven diseases. As we look ahead, we expect 2024 will be a pivotal year for Reviva as we continue the momentum in schizophrenia with topline data from our OLE trial expected in the fourth quarter of 2024 and initiation of a registrational Phase 3 RECOVER-2 trial expected in the first quarter of 2024. Collectively, these data are designed to support our New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), expected in 2025.”