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Reviva Soars as Schizophrenia Treatment Meets Primary Endpoint

Reviva Pharmaceuticals says a Phase 2 clinical trial for its acute schizophrenia treatment meets its primary endpoint.

Reviva Pharmaceuticals Holdings  (RVPH) - Get Reviva Pharmaceuticals Holdings, Inc. Report was skyrocketing Monday after the biotech reported positive results from its Phase 2 clinical trial for its acute schizophrenia treatment.

Shares of the company, based in Cupertino, Calif., were rising 106% to $8.86 in trading Monday.

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Reviva Pharmaceuticals said that the drug candidate, brilaroxazine, met its primary endpoint in the trial, which was reduction in total Positive and Negative Syndrome Scale at the end of the treatment from baseline vs. placebo.

The randomized, placebo-controlled, double-blind Phase 2 clinical study involved 234 subjects with acute exacerbation of schizophrenia or schizoaffective disorder. 

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The drug candidate also met all safety endpoints including clinical, labs, body weight, prolactin, lipids, fasting glucose and EKG.

Brilaroxazine also mitigated positive symptoms and negative symptoms, and improved social functioning and cognition.

In addition, the company said that the U.S. Food and Drug Administration agreed to consider a potential "Superior Safety" label claim, if there is a positive outcome on a relevant endpoint in a pivotal Phase 3 clinical study in schizophrenia.

"We are very excited about our promising phase 2 clinical data and the potential for our drug candidate to address major unmet needs associated with current treatments,” CEO Laxminarayan Bhat said in a statement.

Bhat said that Schizophrenia affects about 3.5 million people in the U.S. and 20 million globally, "yet we believe there are currently no therapies that adequately address the complex mix of positive symptoms, negative symptoms, mood, and cognitive impairment associated with Schizophrenia."

"Our phase 2 data shows that brilaroxazine potentially can mitigate the negative side effects of current treatments and ultimately that would hopefully improve patient’s compliance to the treatment," he said.