CUPERTINO, Calif. - Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) has announced the FDA's acceptance of its Phase 3 RECOVER-2 study for brilaroxazine, a treatment for schizophrenia. This development marks a significant step in the drug's path towards a potential New Drug Application (NDA) submission.
The RECOVER-2 study, a global Phase 3 trial, is randomized, double-blind, and placebo-controlled. It is designed to assess the safety and efficacy of brilaroxazine in about 450 patients with acute schizophrenia. The primary measure of the drug's success will be the reduction in the total score of the Positive and Negative Symptoms Assessment from baseline to Day 28.
Reviva's President and CEO, Laxminarayan Bhat, Ph.D., expressed satisfaction with the FDA's feedback and the study's acceptance. The FDA also indicated that two positive 4-week Phase 3 studies, along with a 12-month long-term safety study, could support an NDA for the acute treatment of schizophrenia. A long-term randomized withdrawal study post-approval will be required to support the maintenance of the drug's effect.
The RECOVER-2 trial is set to begin within this quarter, with expectations to have the necessary data for an NDA submission by the third quarter of 2025. Topline data from a 1-year open-label extension trial for long-term safety is anticipated in Q4 2024.
Schizophrenia, a complex neuropsychiatric disorder, affects approximately 3.5 million people in the United States and 20 million worldwide. Current treatments often fall short in addressing the myriad of symptoms associated with the condition, which can include cognitive impairment, delusions, hallucinations, and disorganized speech or behavior.
Brilaroxazine has demonstrated positive results in the RECOVER-1 trial, meeting all primary and secondary endpoints with significant reductions in symptom domains at week 4. The drug is also being considered for other neuropsychiatric indications, such as bipolar disorder, major depressive disorder, and attention-deficit/hyperactivity disorder, as well as inflammatory diseases.
This announcement is based on a press release statement from Reviva Pharmaceuticals.
InvestingPro Insights
As Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) forges ahead with its Phase 3 RECOVER-2 study for brilaroxazine, the company's financial health and market performance provide additional context for investors. According to real-time data from InvestingPro, Reviva has a market capitalization of $103.02 million, reflecting the current investor valuation of the company. Despite the potential promise of brilaroxazine, the company operates with a negative P/E ratio of -2.20, which suggests that it is not currently profitable, a detail further underscored by a negative price/book ratio of -12.09.
InvestingPro Tips indicate that analysts have recently revised their earnings expectations downwards for the upcoming period, which could signal caution regarding Reviva's short-term financial prospects. Moreover, the company's weak gross profit margins and the expectation that net income will drop this year provide a sobering contrast to the optimism surrounding the clinical development of brilaroxazine. It's also notable that Reviva's stock price often moves counter to market trends, which could represent an additional risk factor for investors.
For those considering an investment in Reviva Pharmaceuticals, it may be prudent to explore the full range of InvestingPro Tips available, which include insights on the company's liquidity and debt levels. With a total of 9 additional tips listed on InvestingPro, investors can gain a more comprehensive understanding of the company's financial situation. To access these insights, visit https://www.investing.com/pro/RVPH and use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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