Positive Results and Completion of Phase 3 Trial for Brilaroxazine in Schizophrenia Patients

Reviva Pharmaceuticals Holdings experienced a significant boost in share prices, soaring by 80% to $6.76. The surge was a direct result of the company's positive topline results and successful completion of its Phase 3 trial. The trial focused on evaluating the efficacy, safety, and tolerability of once-daily brilaroxazine, a serotonin-dopamine signaling modulator, in adults suffering from schizophrenia.

Over the past year, Reviva's stock has demonstrated remarkable growth, increasing by 78%. Although briefly paused due to volatility, it ultimately rebounded, leading to the substantial surge mentioned above.

The Phase 3 trial proved to be a resounding success by achieving its primary endpoint. Brilaroxazine, specifically at a dosage of 50 mg, displayed a statistically significant and clinically meaningful reduction of 10.1 points in the Positive and Negative Syndrome Scale total score in comparison to the placebo at week four.

Furthermore, brilaroxazine demonstrated notable reductions in all major symptom domains and secondary endpoints at week four when compared to the placebo. Even at a lower dosage of 15 mg, brilaroxazine showed promise by outperforming the placebo on the primary endpoint and most secondary endpoints. Furthermore, it achieved statistical significance in two key secondary endpoints.

Looking ahead, Reviva Pharmaceuticals Holdings plans to share long-term data from its trial during the fourth quarter of 2024. Moreover, the company has outlined its intentions to embark on a Phase 3 trial in the first quarter of 2024. If successful, this trial will contribute to Reviva's strategic submission of a new drug application to the FDA, expected in 2025.