Reviva Pharmaceuticals Holdings Inc. (RVPH) announced Tuesday that the FDA wants to see more data before the company can move forward with its schizophrenia drug application. Following a pre-New Drug Application meeting with regulators, Reviva learned that brilaroxazine, its late-stage candidate, needs another Phase 3 clinical trial under its belt.
Brilaroxazine is designed as a novel serotonin-dopamine and neuroinflammatory signaling modulator for treating schizophrenia. The FDA's written feedback specified that a second Phase 3 study would help generate additional efficacy data and expand the safety dataset, among other objectives.
The company isn't throwing in the towel. Subject to securing adequate financing, Reviva intends to kick off the RECOVER-2 Phase 3 trial during the first half of 2026. The new study will mirror the design of the already-completed RECOVER Phase 3 trial, which should at least provide some operational efficiency and comparability.
What Reviva Has Accomplished So Far
The FDA's recommendation came after reviewing Reviva's existing nonclinical and clinical data package. That includes two completed clinical trials—one Phase 2 trial and one Phase 3 trial that featured a one-year open-label extension—plus various clinical pharmacology studies.
According to the company, brilaroxazine has demonstrated some promising characteristics. It showed broad-spectrum efficacy across major symptom domains of schizophrenia, including negative symptoms, in the 790 subjects who participated in the Phase 2 and Phase 3 clinical trials. The drug also posted a generally well-tolerated safety profile, observed in over 900 subjects treated to date.
"We appreciate the clear and constructive feedback from the FDA," said Laxminarayan Bhat, Founder, President, and CEO of Reviva. He highlighted the drug's "broad-spectrum efficacy, a well-characterized and generally favorable safety profile, and favorable treatment adherence observed to date, with convenient once-daily oral administration."
Meanwhile, in China
In related schizophrenia treatment news, China's National Medical Products Administration approved the New Drug Application for Cobenfy (xanomeline and trospium chloride) on Tuesday for treating schizophrenia in adults.
Zai Lab Limited (ZLAB) holds an exclusive license from Karuna Therapeutics, a company acquired by Bristol Myers Squibb Co (BMY), to develop, manufacture, and commercialize Cobenfy in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan.
The Chinese approval is backed by 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.
Market Reaction
Investors didn't take the news well. Reviva Pharmaceuticals (RVPH) shares plunged 48.54% to $0.30 during premarket trading on Tuesday. The stock is now trading perilously close to its 52-week low of $0.25, reflecting significant concern about the additional time and capital required to complete another Phase 3 trial before the company can submit its New Drug Application.