Reviva Pharmaceuticals Plans Second Phase 3 Trial for Brilaroxazine in 2026 Following FDA Feedback
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 23 2025
0mins
Source: Benzinga
- FDA Feedback: Reviva Pharmaceuticals received cautious feedback from the FDA during a pre-NDA meeting, indicating the need for a second Phase 3 trial for brilaroxazine to gather additional efficacy data, which may impact the company's financing and development timeline.
- Trial Plans: Reviva plans to initiate the RECOVER-2 Phase 3 trial in the first half of 2026, designed similarly to the completed RECOVER trial, aimed at further validating the drug's safety and efficacy for schizophrenia treatment.
- Drug Performance: Brilaroxazine demonstrated broad-spectrum efficacy in major symptom domains of schizophrenia in 790 subjects, particularly in negative symptoms, and showed a favorable safety profile in over 900 subjects, indicating its potential in treating the condition.
- Market Reaction: Reviva Pharmaceuticals' stock fell 48.54% to $0.30 in premarket trading on Monday, nearing its 52-week low of $0.25, reflecting market uncertainty regarding its clinical progress.
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Analyst Views on RVPH
Wall Street analysts forecast RVPH stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for RVPH is 5.10 USD with a low forecast of 1.50 USD and a high forecast of 16.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 0.299
Low
1.50
Averages
5.10
High
16.00
Current: 0.299
Low
1.50
Averages
5.10
High
16.00
About RVPH
Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company. The Company discovers, develops, and seeks to commercialize therapeutics for diseases representing unmet medical needs. The Company’s pipeline focuses on the central nervous system, inflammatory, and cardiometabolic diseases. Its pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208. Its lead drug candidate, brilaroxazine, is in clinical development and is to treat multiple neuropsychiatric indications. These include schizophrenia, bipolar disorder (BD), major depressive disorder (MDD), attention-deficit/hyperactivity disorder (ADHD), behavioral and psychotic symptoms of dementia or Alzheimer’s disease (BPSD), and Parkinson’s disease psychosis. Brilaroxazine is also ready for clinical development for two respiratory indications, including pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). Its RP1208 drug candidate is a triple reuptake inhibitor (TRI).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Reviva Pharmaceuticals CEO to Present at Neuroscience Innovation Forum in San Francisco
- Forum Presentation: Reviva Pharmaceuticals' Founder and CEO Laxminarayan Bhat, Ph.D., will present at the Sachs 9th Annual Neuroscience Innovation Forum on January 11, 2026, in San Francisco, showcasing the company's advancements in CNS, inflammatory, and cardiometabolic diseases.
- Pipeline Focus: Reviva's current pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both new chemical entities discovered in-house, aimed at addressing unmet medical needs, which is crucial for societal and patient welfare.
- Patent Protection: The company has secured composition of matter patents for both brilaroxazine and RP1208 in the U.S., Europe, and several other countries, establishing a legal foundation for future commercialization and enhancing its competitive position in the market.
- Company Positioning: As a late-stage biopharmaceutical firm, Reviva is committed to developing next-generation therapeutics for CNS and other significant diseases, highlighting its strategic importance in the biopharmaceutical sector.
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Reviva Pharmaceuticals CEO to Present at 9th Annual Neuroscience Innovation Forum
- Key Presentation Scheduled: Reviva Pharmaceuticals' Founder and CEO, Dr. Laxminarayan Bhat, will present at the Sachs 9th Annual Neuroscience Innovation Forum on January 11, 2026, in San Francisco, showcasing the company's latest advancements in CNS and other disease areas.
- Focus on Unmet Medical Needs: Reviva is dedicated to developing therapies for central nervous system, inflammatory, and cardiometabolic diseases, with its pipeline currently featuring two new chemical entities, brilaroxazine (RP5063) and RP1208, aimed at addressing significant health challenges faced by society and patients.
- Patent Protection Advantage: Reviva has secured composition of matter patents for both brilaroxazine and RP1208 in the U.S., Europe, and several other countries, which not only safeguards its innovative products but also lays a legal foundation for future commercialization efforts.
- Enhancing Industry Influence: By presenting at a key industry forum, Reviva aims to elevate its visibility in the biopharmaceutical sector, attracting potential investors and partners to accelerate the development and market introduction of its products.
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