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Reviva Pharmaceuticals Holdings Inc (NASDAQ:RVPH) shares are surging after the company released topline results of its pivotal Phase 3 RECOVER trial evaluating brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia.
The trial met its primary endpoint, with brilaroxazine at the 50 mg dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-23.9 brilaroxazine 50 mg vs. -13.8 placebo) at week 4.
Roth Capital Partners writes that the data is robust across multiple endpoints, including Positive Symptoms, Negative Symptoms, PANSS Social Cognition, PANSS Excitement/ Agitation, Personal and Social Performance, and CGI-S Score.
Analyst Scott Henry is encouraged by the clear dose-response benefit of 50mg brilaroxazine over 15mg brilaroxazine.
Although the 15mg dose appears on the lower side of clinical benefit, a 30mg dose in the confirmatory pivotal trial could provide additional market benefit.
Roth keeps the Buy rating with the price target of $12.
Roth notes modestly higher weight gain than expected (5.9% on 50mg brilaroxazine versus 2.9% on placebo, which is likely to gather more attention in the open-label extension (OLE) study to evaluate for the duration and magnitude of this effect.
The 15mg brilaroxazine dose increased weight gain by only 2.1%, lower than placebo. Further, there are no notable LDL/HDL differences (numerically favorable for brilaroxazine).
Price Action: RVPH shares are up 42.30% at $5.34 on the last check Monday.
Posted In: RVPH
