Reviva Announces Publication on Clinical Vocal Biomarker Data from the RECOVER Phase 3 Clinical Trial of Brilaroxazine to Treat Negative Symptoms in Schizophrenia

Rhea-AI Summary

Reviva (NASDAQ: RVPH) announced publication on Jan 8, 2026 in Biological Psychiatry reporting vocal biomarker findings from the RECOVER Phase 3 trial of brilaroxazine for schizophrenia. The paper presents speech latency as an interpretable vocal biomarker that classifies moderate-to-severe vs low negative symptoms, correlates with clinician-assessed efficacy, and identifies a subgroup (VBM-positive) with stronger, faster responses to brilaroxazine. The authors state speech latency can be measured from psychiatric interviews across languages and may be used to enrich trials, reduce sample-size needs, and lower trial costs and placebo effects.

Positive

• Peer-reviewed publication in Biological Psychiatry
• Speech latency classifies negative symptom severity
• VBM-positive subgroup showed stronger, faster treatment response
• Speech latency may reduce required trial sample sizes

Negative

• None.

Market Reality Check

$0.3400 Last Close

Volume Volume 5,566,251 is 0.63x the 20-day average of 8,891,244, indicating no volume spike ahead of this news. low

Technical Shares at 0.3462 are trading below the 0.59 200-day MA and far under the 2.17 52-week high, despite a 7.15% pre-news gain.

Peers on Argus

RVPH gained 7.15% while peers were mixed: KZR +0.8%, NEUP +2.32%, OKUR +0.71%, but TENX -4.1% and LSB -20.62%, pointing to a stock-specific move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 29	Conference presentation	Neutral	-5.4%	Corporate presentation announcement for Sachs 9th Annual Neuroscience Innovation Forum.
Dec 23	Regulatory update	Negative	-45.5%	FDA recommended a second Phase 3 trial before NDA submission for brilaroxazine.
Nov 13	Earnings & financing	Negative	-6.6%	Q3 2025 results with net loss, modest cash, and recent equity offering highlighted.
Nov 12	Scientific data	Positive	+3.3%	Neuroscience 2025 presentation on anti-inflammatory effects and RECOVER data for brilaroxazine.
Nov 10	Patent grant	Positive	+9.1%	European patent granted covering brilaroxazine use in pulmonary fibrosis indications.

Pattern Detected

Recent RVPH news, including regulatory updates and financings, has often coincided with downside moves, even when operational updates were constructive.

Recent Company History

Over the past six months, Reviva has focused on advancing brilaroxazine in schizophrenia and strengthening its capital position. Key events included a large regulatory setback on Dec 23, 2025 when FDA feedback called for a second Phase 3 trial, multiple equity and warrant financings disclosed in Q3 2025 filings, and scientific data presentations and a European patent grant. Several of these announcements, particularly regulatory and financing-related items, were followed by negative price reactions, underscoring sensitivity to dilution and development risk as brilaroxazine progresses.

Market Pulse Summary

The stock moved +5.7% in the session following this news. A strong positive reaction aligns with the article’s reinforcement of brilaroxazine’s Phase 3 efficacy, especially on negative symptoms, and the potential for speech latency to streamline future schizophrenia trials. However, past news has not always translated into sustained upside, with several clinically or strategically positive updates followed by drawdowns. Financing needs and prior regulatory guidance for an additional Phase 3 trial remain material overhangs that could influence how durable a move of 7.15% proves to be.

Key Terms

vocal biomarker medical

"an article entitled A Single, Interpretable Vocal Biomarker for Enriching"

A vocal biomarker is a measurable pattern in a person’s voice—such as pitch, speed, breathiness or pauses—that algorithms link to a health condition or behavioral state. For investors it matters because voice-based signals can become a scalable, low-cost way to screen or monitor patients and customers, creating new product and revenue opportunities, but they also carry regulatory, accuracy and privacy risks that affect commercial value.

speech latency medical

"These results show speech latency as a scalable, objective biomarker"

Speech latency is the delay between when a person or system is prompted to speak and when speech actually begins. For investors, it matters because long or inconsistent delays signal performance or health issues in clinical assessments, or indicate responsiveness and quality problems in voice‑enabled products and services — similar to how a slow shutter slows down a camera, delays can degrade user experience and affect adoption or clinical outcomes.

negative symptoms medical

"treat negative symptoms in schizophrenia and support clinician-assessed"

Negative symptoms are reductions or losses in normal behaviors and emotions—such as lack of motivation, flattened facial expression, social withdrawal, and reduced speech—commonly seen in psychiatric conditions. For investors, they matter because these symptoms are hard to treat, drive development of therapies, shape clinical trial goals and regulatory decisions, and therefore influence the potential market size and valuation of companies working on effective treatments.

Phase 3 clinical trial medical

"vocal biomarker data from the RECOVER Phase 3 clinical trial and the"

A phase 3 clinical trial is a large-scale study that tests a new medical treatment or drug to determine if it is safe and effective for widespread use. It often involves hundreds or thousands of participants and compares the new treatment to existing options or a placebo. For investors, the results of this phase are crucial, as successful outcomes can lead to regulatory approval and commercial success, while failures may halt development.

schizophrenia medical

"treat negative symptoms in schizophrenia and support clinician-assessed"

A chronic brain disorder that changes how a person thinks, perceives reality, feels and interacts with others, often causing hallucinations, false beliefs and trouble organizing thoughts or daily life. It matters to investors because the condition creates demand for long‑term treatments, diagnostics and support services; developing effective therapies can be costly, risky and highly regulated, but successful drugs or devices can open large, steady markets—think of it like fixing a deep, complex software bug that many users rely on.

biomarker medical

"Speech latency, an objective measure of verbal response time, is sensitive"

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

AI-generated analysis. Not financial advice.

Findings reinforce brilaroxazine’s treatment effect on negative symptoms and other symptom domains in schizophrenia and support clinician-assessed efficacy outcomes in a Phase 3 trial of brilaroxazine

Findings also support use of speech latency as an enrichment tool that can reduce sample-size and enhance outcomes in clinical trials for schizophrenia

CUPERTINO, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today 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.

“Publication of our vocal biomarker findings from our RECOVER Phase 3 trial in this top-tier, peer-reviewed journal underscores the robustness of our clinical data and the differentiated therapeutic potential of brilaroxazine to address unmet needs in schizophrenia and its major symptom domain negative symptoms,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “These results show speech latency as a scalable, objective biomarker that can be used to evaluate brilaroxazine’s effect on negative symptoms and other core domains of schizophrenia, as well as corroborative of clinician-assessed efficacy from our trial. Beyond this program, we believe this approach could transform limitations of current schizophrenia clinical trials by improving patient stratification, enriching for primary negative symptom populations, and mitigating placebo responses, all of which are factors critical to trial success rates.”

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 (VBM-positive) and low negative symptoms (VBM-negative) 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.

About Brilaroxazine

Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathophysiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF).
Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains including reduction in key proinflammatory cytokines implicated in the pathophysiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine vs. placebo, with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of the CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitors. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD).

Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the FDA for the treatment of PAH and IPF conditions. To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.

About Reviva 
Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding a potential second Phase 3 clinical trial for brilaroxazine in patients with schizophrenia, anticipated efficacy or safety profile, statements about biomarker data and its utility including in terms of reinforcing treatment effect, supporting clinician-assessed efficacy outcomes, and reducing sample-size and enhancing outcomes in clinical trials, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans, clinical and regulatory timelines and expenses, planned or potential additional trials and the timing thereof, planned or intended regulatory submissions and the timing thereof, the timing of availability of additional data or initiation of additional trials, trial results, market opportunity, costs of additional trials including statements about estimated costs, and the risk that the actual cost of trials and the Company’s actual expenses may be higher than the Company projects in its estimates, ability to raise sufficient funding, including in an amount sufficient to support the Company’s intended additional trials, trial results, statements about expected approvals or the timing at which approval might be anticipated, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors, on the Company’s operations, clinical development and clinical trial plans, timelines and estimates, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024, the Company’s Quarterly Reports on Form 10-Q filed since such most recent Annual Report on Form 10-K, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Corporate Contact:
Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD 
www.revivapharma.com

Investor Relations Contact:
LifeSci Advisors, LLC
PJ Kelleher
pkelleher@lifesciadvisors.com

FAQ

What did Reviva (RVPH) publish on Jan 8, 2026 about brilaroxazine?

Reviva published Phase 3 vocal biomarker data in Biological Psychiatry showing speech latency relates to negative symptom response to brilaroxazine.

How does the vocal biomarker (speech latency) impact RECOVER trial design for RVPH?

Speech latency is proposed as an enrichment tool to identify VBM-positive patients, potentially reducing sample sizes and mitigating placebo effects.

What is a VBM-positive patient in the RVPH RECOVER analysis?

VBM-positive refers to patients classified by speech latency as having moderate-to-severe negative symptoms who showed greater treatment response.

Does the publication claim speech latency works across languages for RVPH trials?

Yes; the publication reports speech latency differentiates negative symptom severity across countries and languages.

What clinical benefit did VBM-positive patients show with brilaroxazine in RECOVER?

VBM-positive patients demonstrated faster and stronger responses to brilaroxazine across nearly every measured outcome, especially negative symptoms.

Where can investors view the Reviva publication on RVPH brilaroxazine vocal biomarkers?

The company made the article available on its publications page and noted it appears in Biological Psychiatry.