1. FDA recommended a second Phase 3 trial for brilaroxazine. 2. Reviva plans to initiate RECOVER-2 trial in H1 2026 if funding allows. 3. Brilaroxazine shows broad-spectrum efficacy in schizophrenia with favorable safety. 4. Company enjoys strong clinical data support from previous trials. 5. Regulatory progress depends on FDA guidance and financing.
FAQ
Why Bullish?
The FDA's proactive engagement and recommendation for a new trial indicates confidence in brilaroxazine’s potential, similar to successful cases like Biogen's Aduhelm, which initially faced skepticism but showed positive data later.
How important is it?
The article discusses regulatory feedback that directly influences the probability of future drug approval, making it crucial for RVPH’s stock performance.
Why Long Term?
The initiation of the RECOVER-2 trial in H1 2026 may lead to significant data release and market entry if successful, similar to how pivotal Phase 3 results are crucial for other companies like Neurocrine Biosciences.
Reviva Pharmaceuticals (NASDAQ: RVPH) Announces Important Regulatory Update on Brilaroxazine for Schizophrenia
On December 23, 2025, Reviva Pharmaceuticals Holdings, Inc. (RVPH), a late-stage biopharmaceutical company, revealed a pivotal regulatory update following a pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration (FDA). The feedback from the FDA emphasizes the necessity for a second Phase 3 clinical trial intended to gather further efficacy and safety data for brilaroxazine, a potential treatment for schizophrenia.
FDA Recommendations for Reviva's Brilaroxazine Development
The FDA advised Reviva to conduct an additional Phase 3 trial named RECOVER-2 before submitting an NDA for brilaroxazine. This trial aims to enhance the existing efficacy data and broaden the safety dataset. Reviva plans to initiate this registrational trial in the first half of 2026, contingent on obtaining adequate financing.
Clinical Trial Insights and Efficacy Data
The RECOVER-2 trial will mirror the design of the preceding RECOVER Phase 3 trial of brilaroxazine. The FDA's guidance includes crucial recommendations regarding data analysis methods, presentation techniques, and requirements related to studies focusing on animal pharmacokinetics, human abuse potential, and renal and hepatic impairment.
- Broad-spectrum efficacy in major symptom domains of schizophrenia.
- Engaged 790 subjects in the Phase 2 and Phase 3 trials.
- A generally well-tolerated safety profile, observed in over 900 subjects treated to date.
CEO's Statement on FDA Feedback
Dr. Laxminarayan Bhat, Founder, President, and CEO of Reviva, commented, “We appreciate the clear and constructive feedback from the FDA. Across our robust clinical data package, brilaroxazine continues to show potential to address unmet needs in schizophrenia.” He emphasized the drug’s broad-spectrum efficacy, favorable safety profile, and strong adherence rates linked to its once-daily oral administration.
About Reviva Pharmaceuticals (RVPH)
Reviva is dedicated to discovering, developing, and commercializing innovative therapeutics addressing unmet medical needs in various arenas, including the central nervous system (CNS), inflammatory, and cardiometabolic diseases. The company's pipeline showcases two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities developed in-house.
Reviva currently holds composition of matter patents for brilaroxazine and RP1208 in the United States, Europe, and several other regions.
Forward-Looking Statements and Caution
This announcement contains forward-looking statements that pertain to Reviva’s expectations concerning the development and potential market opportunity for brilaroxazine. These projections involve inherent risks and uncertainties, including the ability to raise sufficient capital to support ongoing trials and operational costs.
Contact Information
For further information, please visit Reviva Pharmaceuticals at www.revivapharma.com.
Investor relations can be reached through LifeSci Advisors, LLC, contacting PJ Kelleher at pkelleher@lifesciadvisors.com.