Reviva reports positive year-long schizophrenia drug study

CUPERTINO, Calif. - Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), a clinical-stage pharmaceutical company with a market capitalization of $45.35 million, focused on developing treatments for central nervous system, inflammatory, and cardiometabolic diseases, announced the successful completion of a year-long Phase 3 study for its drug brilaroxazine, intended for patients with schizophrenia. According to InvestingPro data, the company maintains a strong cash position relative to its debt, positioning it well for continued clinical development.

The study, named RECOVER open-label extension (OLE), aimed to evaluate the long-term safety, tolerability, and efficacy of brilaroxazine. Findings suggest that the drug maintained broad-spectrum efficacy throughout the year and exhibited a well-tolerated safety profile with a 35% discontinuation rate among participants.

Brilaroxazine, described as a novel serotonin dopamine signaling modulator, has shown promise in addressing various symptoms of schizophrenia. The study reported dose-dependent efficacy across major symptom domains, with significant improvements noted in both positive and negative symptoms and social cognition.

Safety data revealed that treatment-emergent adverse events (TEAEs) were mostly mild or moderate, with the most common being headache, insomnia, sleep disturbance, and mild tremor. No serious adverse events related to the drug were reported. Additionally, brilaroxazine did not induce significant changes in movement disorder scales, weight gain was minimal, and no significant cardiac or gastrointestinal side effects were observed.

The study’s results are integral to brilaroxazine’s New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). Reviva aims to address the unmet needs in schizophrenia treatment, as underscored by experts like Dr. Stephen R Marder and Dr. Larry Ereshefsky, who highlighted the drug’s potential in improving patient adherence and clinical outcomes due to its effect on neuroinflammatory markers. Notably, InvestingPro reports that analysts have set price targets ranging from $3 to $16, with two analysts recently revising their earnings expectations upward for the upcoming period.

Reviva also plans to explore brilaroxazine’s applications for other neuropsychiatric conditions, including bipolar disorder, major depressive disorder, and attention-deficit/hyperactivity disorder. The drug has already received Orphan Drug Designation from the FDA for the treatment of certain inflammatory diseases.

The company’s announcement is based on a press release statement, and additional details regarding the OLE trial data were discussed in a virtual investor webcast held today. While InvestingPro analysis indicates the company’s overall financial health score remains weak, with analysts not expecting profitability this year, investors seeking deeper insights into biotech investment opportunities can access additional ProTips and comprehensive financial metrics through an InvestingPro subscription.

In other recent news, Reviva Pharmaceuticals has been the subject of several analyst updates and financial disclosures. Boral Capital has significantly reduced its price target for Reviva Pharmaceuticals from $8.00 to $3.00, citing concerns about the company’s financial position as it advances its lead drug candidate, Brilaroxazine. Despite this reduction, Boral Capital maintains a Buy rating on the stock, though it highlights the increased risk due to financing uncertainties. On the other hand, Benchmark analysts have also adjusted their outlook, lowering the price target from $17 to $14 while maintaining a Speculative Buy rating. This change was influenced by an updated share count from the company’s recent financial filings.

Reviva Pharmaceuticals ended the quarter with $13.5 million in cash reserves, which analysts believe may not be sufficient to support its upcoming milestones. These milestones include the release of the full dataset from the ongoing OLE trial expected in the second quarter of 2025, the start of the RECOVER-2 trial around mid-2025, and the planned submission of a New Drug Application for Brilaroxazine in the fourth quarter of 2026. Both Boral Capital and Benchmark have noted the potential of Brilaroxazine, emphasizing its advantages over existing schizophrenia treatments. The company is exploring partnerships and licensing opportunities to secure additional funding necessary for its clinical programs.

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