Reviva Pharmaceuticals Holdings Inc. (RVPH: NASDAQ) has announced positive topline results from its Phase 3 clinical trial evaluating Brilaroxazine for the treatment of schizophrenia. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo.
The Phase 3 trial data revealed that Brilaroxazine, at a 50 mg dose, achieved a 10.1-point reduction in PANSS total score compared to placebo (-23.9 vs. -13.8, p<0.001) at week four. This improvement suggests a substantial impact on both positive and negative symptoms of schizophrenia.
Mechanism of Action
Brilaroxazine is described as a serotonin-dopamine activity modulator (SDAM). According to EF Hutton analyst Jason Kolbert, it "works by targeting multiple neurotransmitter receptors, such as Serotonin Receptors, where Brilaroxazine acts as a partial agonist at 5-HT1A, 5-HT2A, 5-HT2B, 5-HT2C, and 5-HT7."
Potential Beyond Schizophrenia
While the primary focus is on schizophrenia, Kolbert noted potential applications beyond schizophrenia, including bipolar disorder, depression, and inflammatory diseases such as psoriasis, idiopathic pulmonary fibrosis (IPF), and pulmonary arterial hypertension (PAH). However, the valuation focus remains on the schizophrenia market in the U.S. and Europe.
Regulatory and Strategic Plans
Reviva Pharmaceuticals anticipates filing a New Drug Application (NDA) for Brilaroxazine in Q1 2026. The company is also focused on securing fundamental institutional capital to support its development and commercialization efforts.
Analyst Perspective
EF Hutton initiated coverage on Reviva Pharmaceuticals with a Buy rating and a price target of US$15.00. Kolbert's valuation methodology incorporates multiple indications with a probability of success factor of 70% for the schizophrenia indication. He applies a 30% discount rate to his models and assumes additional capital will be raised.
Upcoming Milestones
Key events for investors to watch include long-term safety data from the Phase 3 long-term trial (n=100, 1-year follow-up), expected by the end of 2024, and the Phase 3 RECOVER-2 Study.
