Business
Reviva Reports First Quarter 2024 Financial Results and Recent Business Highlights
– Gained alignment with U.S. Food and Drug Administration (FDA) on brilaroxazine clinical trials for New Drug Application (NDA) submission in schizophrenia –
About this update from Reviva Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"– Gained alignment with U.S. Food and Drug Administration (FDA) on brilaroxazine clinical trials for New Drug Application (NDA) submission in schizophrenia – – Registrational RECOVER-2 trial expected to initiate Q2 2024; topline data expected Q3 2025 – – Topline data from 1-year open-label extension (OLE) trial expected Q4 2024 – CUPERTINO, Calif., May 14, 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 reported financial results for the first quarter ended March 31, 2024 and summarized recent business highlights. “This quarter we made strong progress across our late-stage brilaroxazine program in schizophrenia. Importantly, we gained registrational clarity from the FDA on the requirements for an NDA submission which we are on track to complete in the fourth quarter of 2025,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “In 2024, we expect several upcoming catalysts including dosing of the first patient in our registrational RECOVER-2 trial in the second quarter, and topline data from our 1-year OLE trial which will inform on the long-term safety and efficacy of brilaroxazine in the fourth quarter of this year. This is a potentially transformative time for Reviva and we remain focused on our mission to bring brilaroxazine to more patients around the world.” First Quarter 2024 and Recent Business Highlights Corporate Highlights Hosted key opinion leader (KOL) webinar on topline RECOVER-1 Phase 3 data for brilaroxazine and the unmet medical need and current treatment landscape for schizophrenia, featuring presentations by Larry Ereshefsky, PharmD, BCPP, FCCP, of Follow the Molecule and Mark Opler, PhD, MPH of WCG (February 2024) Clinical Program Highlights Announced alignment with the U.S. Food and Drug Administration (FDA) on registrational Phase 3 program for brilaroxazine in schizophrenia (April 2024) Acceptance of a 4-week RECOVER-2 studyIndication 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 submission for the acute treatment of schizophrenia...