Reviva Pharmaceuticals Publishes Study on Brilaroxazine in Biological Psychiatry
Reviva Pharmaceuticals Holdings announced the publication, in the peer-reviewed journal Biological Psychiatry, of an article entitled A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials that highlights clinical vocal biomarker data from the RECOVER Phase 3 clinical trial and the therapeutic potential of brilaroxazine for the treatment of schizophrenia. The publication is available at revivapharma.com/publications. Highlights of brilaroxazine vocal or speech biomarker data from the pivotal Phase 3 RECOVER trial in schizophrenia include: Speech latencies classified the presence of moderate to severe negative symptoms and low negative symptoms in patients randomized to the RECOVER trial. A greater percentage of VBM positive patients showed significant treatment response, as measured by clinician assessed efficacy outcomes of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia. VBM-positive patients showed a fast and strong response to brilaroxazine treatment in nearly every outcome measure, especially negative symptoms. Speech latency, an objective measure of verbal response time, is sensitive to cognitive, social, and motivational factors, and can be assayed from psychiatric interviews. Speech latency differentiates patients with moderate-to-severe vs. low negative symptoms across countries and languages. As an enrichment tool, it could reduce sample-size needs and enhance the trial outcomes thereby reducing clinical trial costs and burden.
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- 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.

- 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.
- Credit Support: Galectin Therapeutics Inc. secured a $10 million credit line, ensuring funding to cover expected expenditures through March 2027, thereby enhancing its R&D capabilities in the NASH cirrhosis treatment space.
- FDA Guidance: The FDA provided written feedback on Galectin's regulatory pathway for belapectin, marking a significant advancement in the company's drug development efforts, which could expedite its product's market entry.
- Market Reaction: Galectin's stock rose by 1% to $4.03 in Wednesday's trading, reflecting investor optimism regarding its financing and FDA support.
- Strategic Implications: This credit line and FDA guidance will provide Galectin with essential funding and regulatory backing in the competitive biopharmaceutical market, aiding its future clinical trials and market launch efforts.

- Regulatory Requirement: The FDA has recommended that Reviva initiate the second Phase 3 trial, RECOVER-2, before submitting a New Drug Application, which will delay the filing timeline to 2027 as it aims to enroll approximately 790 patients to expand efficacy data and strengthen long-term safety evidence.
- Drug Development Progress: Brilaroxazine, Reviva's lead candidate, is designed to address both positive and negative symptoms of schizophrenia and has shown a favorable safety profile in over 900 subjects, indicating its potential competitiveness in the treatment landscape.
- Clinical Trial Results: Results from the completed RECOVER Phase 3 trial demonstrated statistically significant improvements in the Positive and Negative Syndrome Scale total score, with sustained efficacy observed in a one-year open-label extension, underscoring the clinical value of the drug.
- Market Reaction: Reviva's stock has traded between $0.25 and $2.17 over the past year, closing at $0.32, down 45.54% from the previous day, reflecting negative market sentiment regarding the FDA's delay.
- Market Underperformance: The pharmaceutical sector declines approximately 1.6%, with Reviva Pharmaceuticals' shares plummeting 45.9%, which may undermine investor confidence in the industry and impact future financing and R&D capabilities.
- Significant Individual Stock Impact: NovaBay Pharmaceuticals also sees a 19.1% drop, exacerbating negative sentiment towards the pharmaceutical sector, potentially putting pressure on the stock prices of other related companies and affecting overall industry valuations.
- Investor Reaction: The substantial declines in Reviva and NovaBay may lead to a cautious investment sentiment towards the pharmaceutical sector, impacting capital inflows and the industry's growth prospects.
- Uncertain Industry Outlook: With the ongoing slump in pharmaceutical stocks, companies within the sector may face greater financing challenges, affecting new drug development and competitive positioning in the market.
- Dow Jones Index Rise: The Dow Jones index increased by over 100 points on Tuesday, closing at 48,469.41, indicating a moderate market recovery despite disappointing economic data.
- Durable Goods Orders Decline: U.S. durable goods orders fell by 2.2% month-over-month to $307.4 billion in October, significantly missing market expectations of a 1.5% decline, reflecting weak manufacturing demand that could impact future economic growth.
- Accelerated GDP Growth: The U.S. GDP grew at an annualized rate of 4.3% in the third quarter, up from 3.8% in the previous quarter and exceeding market estimates of 3.3%, indicating potential for economic recovery that may positively influence the stock market.
- Mixed Sector Performance: Communication services rose by 0.5% while consumer staples fell by 0.5%, demonstrating varied market reactions across sectors, prompting investors to monitor industry dynamics for strategic adjustments.








