Reviva Pharmaceuticals Holdings, Inc. (RVPH) announced that the U.S. FDA has recommended the initiation of a second Phase 3 trial RECOVER-2 for Brilaroxazine before submitting a New Drug Application for the treatment of schizophrenia.
FDA said the second Phase 3 trial should generate additional efficacy and safety data prior to NDA submission. This regulatory hurdle effectively delays Reviva's filing timeline to at least 2027.
Schizophrenia is a chronic and severe mental disorder affecting how a person thinks, feels, and behaves. Current therapies often leave patients with residual symptoms or intolerable side effects, underscoring the need for new treatment options.
Brilaroxazine is Reviva's lead candidate, an oral serotonin-dopamine and neuroinflammatory signalling modulator designed to address both positive and negative symptoms of schizophrenia while offering a favourable safety profile.
The completed RECOVER Phase 3 trial is a randomized, double-blind, placebo-controlled study. Results demonstrated statistically significant improvements in Positive and Negative Syndrome Scale total score, including benefits in negative symptoms, with efficacy sustained in a one-year open-label extension.
Alongside an earlier Phase 2 study, Brilaroxazine has shown broad-spectrum efficacy across major symptom domains of schizophrenia. A generally well-tolerated safety profile has been observed in more than 900 subjects to date.
In a written feedback from a pre-NDA meeting, the agency requested a RECOVER-2, a second Phase 3 study enrolling approximately 790 patients, to expand the efficacy dataset and strengthen long-term safety evidence.
Reviva plans to initiate RECOVER-2 in the first half of 2026, subject to financing. The company emphasized that the upcoming trial will build on the strong safety and adherence profile observed to date, with once-daily oral dosing offering potential advantages over current therapies.
RVPH has traded between $0.25 and $2.17 over the past year. On Tuesday shares finished at $0.32 on a volume of 55.37 million, down 45.54 percent from the previous day's close of $0.62. In the pre-market session, the stock is at $0.3245, up 1%.
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