Reviva Pharmaceuticals Holdings Inc. (NASDAQ:RVPH) on Tuesday announced a regulatory update following a pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration (FDA).
The update is regarding brilaroxazine, a novel serotonin-dopamine and neuroinflammatory signaling modulator, in late-stage development for schizophrenia.
In written feedback, the FDA recommended a second Phase 3 clinical trial for brilaroxazine in patients with schizophrenia to, among other things, generate additional efficacy data and expand the safety dataset.
Subject to sufficient financing, Reviva plans to initiate the RECOVER-2 Phase 3 trial in the first half of 2026.
The RECOVER-2 trial will be similar in design to the completed RECOVER Phase 3 trial of brilaroxazine.
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“We appreciate the clear and constructive feedback from the FDA…, with data reflecting broad-spectrum efficacy, a well-characterized and generally favorable safety profile, and favorable treatment adherence observed to date, with convenient once-daily oral administration,” said Laxminarayan Bhat, Founder, President, and CEO of Reviva.
The recommendation follows FDA review of the company’s existing nonclinical and clinical data package, including two completed clinical trials (one Phase 2 trial and one Phase 3 trial that included a 1-year open-label extension) and clinical pharmacology studies.
The company said that brilaroxazine has demonstrated:
Broad-spectrum efficacy in major symptom domains of schizophrenia, including negative symptoms, in the 790 subjects that participated in the Phase 2 and Phase 3 clinical trials.
A generally well-tolerated safety profile, observed in over 900 subjects treated to date.
On Tuesday, China’s National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of schizophrenia in adults.
Zai Lab Limited (NASDAQ:ZLAB) has an exclusive license from Karuna Therapeutics, Inc., a company acquired by Bristol Myers Squibb Co (NYSE:BMY), to develop, manufacture, and commercialize Cobenfy in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).
The approval is supported by the results from a Phase 1 pharmacokinetics study conducted in China, the Phase 3 China study (ZL-2701-001), and data from three global EMERGENT clinical studies.
RVPH Price Action: Reviva Pharmaceuticals shares were down 48.54% at $0.30 during premarket trading on Monday. The stock is trading near its 52-week low of $0.25, according to Benzinga Pro data.
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