CUPERTINO, Calif., Nov. 12, 2025 (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 announced that the anti-inflammatory impacts of brilaroxazine from the Phase 3 RECOVER double-blind trial in patients with acute exacerbation of schizophrenia, and from the long-term o ...

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [1][3] - The company will present negative symptom data for brilaroxazine from the Phase 3 RECOVER trial at the CNS Summit 2025 [1][2] Company Overview - Reviva's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] - The company has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]

Core Insights - Veru Inc. announced positive topline efficacy data from the Phase 2b QUALITY study, which demonstrated that enobosarm in combination with GLP-1 receptor agonists can lead to selective fat loss while preserving lean mass [3][4][8] - The company plans to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program, expected to provide regulatory clarity [2][11] - Financial results for the second quarter of fiscal 2025 showed a decrease in net loss compared to the previous year, indicating improved financial performance [27][34] Clinical Development - The Phase 2b QUALITY study showed a 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide [4] - The enobosarm 3mg + semaglutide combination resulted in a >99% mean relative reduction in lean mass loss, outperforming the 6mg dose [4] - The ongoing Phase 2b extension maintenance study aims to evaluate the effects of stopping GLP-1 receptor agonist treatment while continuing enobosarm [10] Safety and Efficacy - Unblinded safety data from the Phase 2b QUALITY study is expected to be released soon, with no significant safety concerns reported so far [9] - The treatment with enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [5] - Enobosarm treatment preserved lean mass, leading to a shift in body composition towards greater fat loss [5][8] Financial Performance - For the second quarter of fiscal 2025, research and development expenses increased to $3.9 million from $3.0 million, while selling, general, and administrative expenses decreased to $5.2 million from $5.9 million [27] - The net loss from continuing operations decreased to $7.9 million, or $0.05 per share, compared to $8.7 million, or $0.06 per share in the previous year [27][34] - Cash and cash equivalents were reported at $20.0 million as of March 31, 2025, down from $24.9 million as of September 30, 2024 [24] Future Plans - The company is developing a novel modified release oral formulation of enobosarm, expected to enter Phase 1 bioavailability clinical trials in the first half of 2025 [14] - A Phase 3 clinical program is planned, focusing on older patients with obesity or overweight, assessing the effect of enobosarm on physical function and body composition [12][21] - Veru is exploring the clinical development of sabizabulin for treating inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [15][19]

Core Insights - Reviva Pharmaceuticals Holdings, Inc. announced topline data from the long-term open label extension of the Phase 3 RECOVER study evaluating brilaroxazine for schizophrenia, to be presented at the 2025 Congress of the Schizophrenia International Research Society [1][2] Company Overview - Reviva is a late-stage biopharmaceutical company focused on developing next-generation therapeutics for unmet medical needs, particularly in central nervous system (CNS), inflammatory, and cardiometabolic diseases [3] - The company's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] - Reviva has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]