- Written FDA recommendations include a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for schizophrenia --
- Current data package highlights well-tolerated long-term safety profile, broad-spectrum clinical activity, and favorable adherence for once daily brilaroxazine up to one year -
- Initiation of RECOVER-2 registrational trial planned in mid-2026 -
CUPERTINO, Calif., March 30, 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 reported financial results for the full year ended December 31, 2025 and summarized recent business highlights.
"With clear and actionable guidance from the Food and Drug Administration (FDA), we are advancing toward initiating our second registrational phase 3 trial (RECOVER-2) and preparing the data package for supporting a New Drug Application (NDA) for brilaroxazine for the treatment of schizophrenia," said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. "Our strong clinical package, including durable efficacy and consistent safety and tolerability from acute through stable schizophrenia up to one year, and favorable treatment adherence with once-daily dosing, underscores the potential of brilaroxazine to address meaningful unmet needs for patients with schizophrenia. With plans to initiate the RECOVER-2 registrational trial in mid-2026, we remain focused on disciplined execution and bringing this promising therapy toward regulatory approval."
Business Highlights
Clinical Development and Regulatory
-- Published clinical vocal biomarker data from the RECOVER Phase 3
clinical trial highlighting the therapeutic potential of
brilaroxazine for the treatment of schizophrenia in the
peer-reviewed journal Biological Psychiatry, in an article
entitled A Single, Interpretable Vocal Biomarker for Enriching
Antipsychotic Clinical Trials.
-- Announced a regulatory update following a pre-NDA meeting with the
U.S. Food and Drug Administration (FDA) regarding brilaroxazine.
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.
-- Existing nonclinical and clinical data packages include 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, and anxiety/depression in the Phase 2 and
Phase 3 (double-blind and open-label portions) clinical trials
-- A generally well-tolerated safety profile observed in over 900 subjects
treated to date
-- Positive full dataset and successful completion of the Company's
Phase 3 RECOVER open-label extension (OLE) 1-year study evaluating
the long-term safety, tolerability and efficacy of brilaroxazine
in patients with schizophrenia (N=446) reported in June 2025 and
additional analyses reported in October 2025. A summary of the OLE
results is provided here:
-- Once daily brilaroxazine (pooled 15, 30, and 50 mg, N=159)
in the patient population that completed one year treatment
led to robust broad-spectrum efficacy that was sustained
over 1-year including PANSS total score (--18.1), positive
symptoms (--5.0), negative symptoms (--4.4), negative
symptoms Marder factor (-4.4), general psychopathology
(-8.7), personal & social performance (11.3) and CGI-S
(-0.8, >=1 point improvement in 78% of patients).
-- Only <1% patients reported symptom relapse on treatment
over 1-year.
-- No clinically meaningful changes in movement disorder
scales used for evaluating motor side effects such as
akathisia and extrapyramidal symptoms.
-- Benign weight gain (1.5 kg) compared to baseline over 52
weeks (1 year treatment). Weight gain is not dose-dependent
and possibly related to lifestyle or diet.
-- Favorable and consistent improvement in lipid profile, and
blood sugar levels were comparable to baseline over 52
weeks (1 year) across all 3 dose groups.
-- Not associated with hormonal imbalance and sexual side
effects. Elevated prolactin levels reported at the
beginning of the study were significantly reduced to normal
or near normal in all three dose groups. Improvement in
thyroid hormone levels and sexual function reported.
-- No incidence of clinically significant cardiac or
gastrointestinal side effects. No incidence of drug induced
liver injury (DILI).
Non-Clinical Development
-- Completed NDA-enabling carcinogenicity studies (2-year in rats and
6-month in transgenic mice) on brilaroxazine to support the NDA for
schizophrenia indication.
-- Completed cGMP manufacturing of registration batches of brilaroxazine
drug substance (also called active pharmaceutical ingredient).
-- Completed cGMP manufacturing of registration batches of brilaroxazine
drug products.
Intellectual Property
-- Continuing efforts aimed at expansion of a strong diversified patent
portfolio comprising composition of matter and lifecycle management
strategies for innovative formulations and method of treatment for
different major indications.
-- Filed three new U.S. provisional patent applications: two directed to
brilaroxazine composition and one directed to using brilaroxazine for
treating a specific symptom.
-- European Patent (EP3749324) granted by the European Patent Office (EPO)
in November 2025, covering use of brilaroxazine for the treatment of
pulmonary fibrosis, including idiopathic pulmonary fibrosis (IPF), adding
to Reviva's existing patent protection in key markets around the world
including the United States, China and Japan.
Financing
-- Completed public equity offering in June 2025, raising gross proceeds of
$10.0 million, before deducting placement agent fees and other offering
expenses.
-- Completed public equity offering in September 2025, raising gross
proceeds of $9.0 million, before deducting placement agent fees and other
offering expenses.
-- Completed public equity offering in March 2026, raising gross proceeds of
$10.0 million, before deducting placement agent fees and other offering
expenses.
-- The Company currently intends to use the net proceeds from the March 2026
offering together with its existing cash and cash equivalents to fund
research and development activities, including its planned RECOVER-2
Phase 3 trial for brilaroxazine in schizophrenia, and for working capital
and other general corporate purposes.
-- Immediately following the closing of the March 2026 offering, the Company
has cash and cash equivalents of approximately $23 million (unaudited),
which the Company believes will fund its operations into Q1-2027.
Anticipated Milestones and Events
-- Plans to initiate brilaroxazine second registrational Phase 3 trial
(RECOVER-2) for schizophrenia in mid-2026, with trial-related activities
for RECOVER-2 planned to start in Q2-2026 and patient enrollment in the
U.S. planned to begin in Q3-2026.
-- Additional publications on brilaroxazine for the treatment of
schizophrenia expected in 2026.
-- Pursuing partnership opportunities for the development of our pipeline.
Financial Results for 2025
-- The Company reported a net loss of approximately $19.9 million, or $5.48
per share, for the fiscal year ended December 31, 2025, compared to a net
loss of approximately $29.9 million, or $17.73 per share, for the fiscal
year ended December 31, 2024. All share and per share amounts in this
press release including the accompanying tables have been retrospectively
adjusted as appropriate to reflect the Company's one-for-twenty (1:20)
reverse stock split of the Company's issued and outstanding common stock
effected on March 9, 2026.
-- As of December 31, 2025, the Company's cash and cash equivalents totaled
approximately $14.4 million compared to approximately $13.5 million as of
December 31, 2024.
About Reviva
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March 30, 2026 06:05 ET (10:05 GMT)
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