Reviva Announces Regulatory Update Regarding the Development of Brilaroxazine for the Treatment of Schizophrenia

Rhea-AI Summary

Reviva (NASDAQ: RVPH) announced a regulatory update on Dec 23, 2025 following a pre-NDA meeting with the FDA about brilaroxazine for schizophrenia. The FDA provided written feedback recommending a second Phase 3 trial to generate additional efficacy and safety data prior to an NDA submission. Reviva plans to initiate the RECOVER-2 registrational trial in H1 2026, subject to sufficient financing. The company said its current data package shows broad-spectrum efficacy across symptom domains in 790 subjects, a generally well-tolerated safety profile in over 900 subjects, favorable adherence, and up to one-year safety data for once-daily oral dosing. FDA also gave guidance on data analysis, animal PK, abuse potential, and renal/hepatic impairment studies.

Positive

• Broad-spectrum efficacy observed in 790 trial subjects
• Generally well-tolerated safety profile in > 900 subjects
• Up to one-year safety and adherence data for once-daily dosing

Negative

• FDA recommended a second Phase 3 trial before NDA submission
• RECOVER-2 initiation is conditional on sufficient financing

Key Figures

RECOVER subject count 790 subjects Phase 2 and Phase 3 (double-blind and open-label) schizophrenia trials

Treated subject count Over 900 subjects Total brilaroxazine-treated subjects across clinical development program

Treatment duration Up to one year Once-daily brilaroxazine exposure in RECOVER open-label extension

Planned RECOVER-2 start H1 2026 Targeted initiation of second Phase 3 trial, subject to financing

Dosing schedule Once daily Oral administration frequency for brilaroxazine in schizophrenia

Market Reality Check

$0.3069 Last Close

Volume Volume 3,327,152 is at 0.71x the 20-day average, suggesting typical pre-news activity. normal

Technical Shares at $0.59 are trading below the $0.63 200-day MA and 72.81% under the 52-week high.

Peers on Argus

Peer moves are mixed: KZR up 1.76%, OKUR up 1.37%, while TENX and LSB fell 5.68% and 20.62%, indicating company‑specific drivers for RVPH.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 13	Earnings and pipeline	Positive	-6.6%	Q3 2025 results plus pre‑NDA and NDA timing update for brilaroxazine.
Nov 12	Clinical data poster	Positive	+3.3%	Neuroscience 2025 presentation on anti‑inflammatory data from RECOVER trials.
Nov 10	IP/patent news	Positive	+9.1%	European patent granted for use of brilaroxazine in pulmonary fibrosis.
Oct 29	Investor conference	Neutral	+1.7%	Participation in Spartan Capital investor conference to engage with investors.
Oct 28	Clinical data presentation	Positive	-2.4%	CNS Summit 2025 poster on negative symptom data from RECOVER trials.

Pattern Detected

News with clear clinical or IP positives has often coincided with positive moves, while broader earnings or program updates have sometimes seen negative reactions.

Recent Company History

Over the last few months, Reviva has focused on advancing brilaroxazine and strengthening its position. Key events include a European patent for pulmonary fibrosis and multiple data presentations from the RECOVER Phase 3 program, alongside Q3 2025 results showing a $4.0 million net loss and prior financings. This announcement follows the planned pre‑NDA interaction and reflects updated FDA guidance on development steps before a potential NDA for schizophrenia.

Market Pulse Summary

The stock dropped -45.5% in the session following this news. A negative reaction despite detailed regulatory guidance fits prior instances where broader updates led to weakness, such as the Q3 release that saw a -6.58% move. The FDA’s request for a second Phase 3 adds time and cost before any NDA, while earlier filings highlighted going‑concern language and recent equity financings, factors that could have amplified downside pressure in response to this update.

Key Terms

pre-nda regulatory

"Written feedback from FDA pre-NDA meeting includes a recommendation..."

A "pre-nda" is an early-stage agreement where parties share confidential information before fully committing to a deal or partnership. It acts like a promise to keep shared details private, allowing them to explore opportunities safely. For investors, it signals serious interest and helps ensure that sensitive information remains protected as discussions progress.

new drug application regulatory

"pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

phase 3 medical

"recommended a second Phase 3 clinical trial for brilaroxazine in patients with schizophrenia"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

placebo-controlled medical

"two completed randomized, double-blind, placebo-controlled, multicenter clinical trials"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

open label extension medical

"one Phase 3 trial that included a 1-year open label extension"

An open-label extension is a follow-on phase of a clinical trial where participants keep receiving the experimental drug and both doctors and patients know what treatment is being given. It matters to investors because it produces longer-term safety and effectiveness information, helps regulators and companies assess ongoing benefits or risks, and can indicate whether a therapy has staying commercial value — like an extended test drive revealing durability and real-world performance.

pharmacokinetics medical

"data requirements for studies of animal pharmacokinetics, human abuse potential"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

AI-generated analysis. Not financial advice.

Written feedback from FDA pre-NDA meeting includes a recommendation to conduct a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for the treatment of schizophrenia

Current data package highlights long-term safety profile, broad-spectrum clinical activity, and favorable adherence observed to date for once daily brilaroxazine over up to one year

Initiation of RECOVER-2 registrational trial planned in H1 2026, subject to sufficient financing

CUPERTINO, Calif., Dec. 23, 2025 (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 a regulatory update following a pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding brilaroxazine, a novel serotonin-dopamine and neuroinflammatory signaling modulator, in late-stage development for the treatment of schizophrenia.

In written feedback, the FDA recommended a second Phase 3 clinical trial for brilaroxazine in patients with schizophrenia to, among other things, generate additional efficacy data and expand the safety dataset. Subject to sufficient financing, Reviva plans to initiate the RECOVER-2 Phase 3 trial in the first half of 2026. The RECOVER-2 trial will be similar in design to the completed RECOVER Phase 3 trial of brilaroxazine. The FDA also provided the Company with guidance for, among other topics, methods of data analysis, methods of data presentation, and data requirements for studies of animal pharmacokinetics, human abuse potential, and renal and hepatic impairment.

“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, with data reflecting broad-spectrum efficacy, a well-characterized and generally favorable safety profile, and favorable treatment adherence observed to date, with convenient once-daily oral administration,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “We are committed to working closely with the FDA to generate the additional efficacy and safety data necessary to support a potential NDA and to potentially bring brilaroxazine to patients with schizophrenia as quickly as possible. Subject to sufficient financing, we plan to initiate RECOVER-2 in the first half of 2026.”

The recommendation follows FDA review of the Company’s existing nonclinical and clinical data package, including two completed randomized, double-blind, placebo-controlled, multicenter clinical trials (one Phase 2 trial and one Phase 3 trial that included a 1-year open label extension) and clinical pharmacology studies designed to support a potential NDA filing. Across the clinical development program, brilaroxazine has demonstrated the following:

• Broad spectrum efficacy in major symptom domains of schizophrenia, including negative symptoms, in the 790 subjects that participated in the Phase 2 and Phase 3 (double-blind and open-label portions) clinical trials
• A generally well-tolerated safety profile, observed in the over 900 subjects treated to date

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, 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) announce about brilaroxazine on December 23, 2025?

Reviva said the FDA recommended a second Phase 3 trial and provided guidance on data requirements; RECOVER-2 is planned for H1 2026 subject to financing.

Why does the FDA want a second Phase 3 trial for brilaroxazine (RVPH)?

The FDA recommended a second trial to generate additional efficacy and safety data prior to an NDA submission.

When does Reviva plan to start the RECOVER-2 Phase 3 trial for RVPH's brilaroxazine?

Subject to sufficient financing, Reviva plans to initiate RECOVER-2 in the first half of 2026.

How large is Reviva's existing clinical dataset for brilaroxazine?

The company reports 790 subjects in Phase 2/3 efficacy datasets and over 900 subjects treated overall.

What safety and operational guidance did the FDA provide to Reviva for brilaroxazine?

The FDA provided guidance on methods of data analysis, data presentation, animal PK, human abuse potential, and renal/hepatic impairment studies.