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Reviva Announces Positive Full Dataset for 1-Year Phase 3 RECOVER Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia

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Reviva Pharmaceuticals (NASDAQ: RVPH) announced positive one-year data from its Phase 3 RECOVER open-label extension study of brilaroxazine for schizophrenia treatment. The study demonstrated sustained broad-spectrum efficacy across all symptom domains with a 35% discontinuation rate. The drug showed significant improvements in PANSS scores, with total score improvements of -10.7 at 6 months and -18.1 at 12 months. Safety data revealed only 8.5% of participants reported treatment-emergent adverse events, mostly mild (6.5%) or moderate (2.0%). Notable findings include minimal weight gain (1.52 kg), no drug-related serious adverse events, and improvements in multiple neuroinflammatory markers. The study's success supports brilaroxazine's potential as a novel treatment for schizophrenia, particularly addressing persistent negative symptoms and poor functional outcomes.
Reviva Pharmaceuticals (NASDAQ: RVPH) ha annunciato dati positivi a un anno dallo studio di estensione in aperto di Fase 3 RECOVER su brilaroxazine per il trattamento della schizofrenia. Lo studio ha mostrato un'efficacia sostenuta e ampia in tutti i domini sintomatici, con un tasso di interruzione del 35%. Il farmaco ha evidenziato miglioramenti significativi nei punteggi PANSS, con una riduzione totale di -10,7 a 6 mesi e -18,1 a 12 mesi. I dati di sicurezza hanno rilevato che solo l'8,5% dei partecipanti ha riportato eventi avversi emergenti dal trattamento, per lo più lievi (6,5%) o moderati (2,0%). Tra i risultati rilevanti si segnalano un aumento di peso minimo (1,52 kg), assenza di eventi avversi gravi correlati al farmaco e miglioramenti in diversi marcatori neuroinfiammatori. Il successo dello studio supporta il potenziale di brilaroxazine come trattamento innovativo per la schizofrenia, in particolare per i sintomi negativi persistenti e i risultati funzionali scarsi.
Reviva Pharmaceuticals (NASDAQ: RVPH) anunció datos positivos a un año del estudio de extensión abierto de fase 3 RECOVER con brilaroxazine para el tratamiento de la esquizofrenia. El estudio demostró una eficacia sostenida y de amplio espectro en todos los dominios sintomáticos, con una tasa de discontinuación del 35%. El medicamento mostró mejoras significativas en las puntuaciones PANSS, con una reducción total de -10,7 a los 6 meses y -18,1 a los 12 meses. Los datos de seguridad revelaron que solo el 8,5% de los participantes reportaron eventos adversos emergentes del tratamiento, en su mayoría leves (6,5%) o moderados (2,0%). Entre los hallazgos notables se incluyen un aumento de peso mínimo (1,52 kg), ausencia de eventos adversos graves relacionados con el medicamento y mejoras en múltiples marcadores neuroinflamatorios. El éxito del estudio respalda el potencial de brilaroxazine como un tratamiento novedoso para la esquizofrenia, especialmente para los síntomas negativos persistentes y los malos resultados funcionales.
Reviva Pharmaceuticals (NASDAQ: RVPH)ëŠ� 조현ë³� 치료ë¥� 위한 브릴ë¼ë¡ì‚¬ì§„ì� 3ìƒ� RECOVER 오픈ë¼ë²¨ 연장 연구ì—서 1ë…„ê°„ ê¸ì •ì ì¸ ë°ì´í„°ë¥¼ 발표했습니다. ì� 연구ëŠ� 모든 ì¦ìƒ ì˜ì—­ì—서 ì§€ì†ì ì� ê´‘ë²”ìœ� 효능ì� ìž…ì¦í–ˆìœ¼ë©�, ì¤‘ë‹¨ìœ¨ì€ 35%였습니ë‹�. ì•½ë¬¼ì€ PANSS ì ìˆ˜ì—서 유ì˜ë¯¸í•œ 개선ì� 보였으며, 6개월ì—는 ì´ì ì� -10.7, 12개월ì—는 -18.1ë¡� 개선ë˜ì—ˆìŠµë‹ˆë‹�. 안전ì„� ë°ì´í„°ì— 따르ë©� 참가ìžì˜ 8.5%ë§Œì´ ì¹˜ë£Œ ì¤� ë°œìƒí•� ì´ìƒ ë°˜ì‘ì� 보고했으ë©�, 대부ë¶� ê²½ì¦(6.5%) ë˜ëŠ” 중등ë�(2.0%)였습니ë‹�. 주목í•� 만한 결과로는 체중 ì¦ê°€ê°€ 미미(1.52kg), 약물 ê´€ë � 심ê°í•� ì´ìƒ ë°˜ì‘ ì—†ìŒ, 여러 ì‹ ê²½ì—¼ì¦ ë§ˆì»¤ì� 개선 ë“±ì´ ìžˆìŠµë‹ˆë‹¤. ì� 연구ì� ì„±ê³µì€ íŠ¹ížˆ ì§€ì†ì ì� ë¶€ì •ì  ì¦ìƒê³� 기능 ì €í•� 문제ë¥� 해결하는 ì¡°í˜„ë³‘ì˜ ìƒˆë¡œìš� 치료제로ì„� 브릴ë¼ë¡ì‚¬ì§„ì� 가능성ì� 뒷받침합니다.
Reviva Pharmaceuticals (NASDAQ : RVPH) a annoncé des données positives sur un an issues de l'étude d'extension en ouvert de phase 3 RECOVER portant sur la brilaroxazine pour le traitement de la schizophrénie. L'étude a démontré une efficacité soutenue et à large spectre sur tous les domaines symptomatiques, avec un taux d'arrêt de 35 %. Le médicament a montré des améliorations significatives des scores PANSS, avec une amélioration totale de -10,7 à 6 mois et de -18,1 à 12 mois. Les données de sécurité ont révélé que seulement 8,5 % des participants ont rapporté des événements indésirables liés au traitement, principalement légers (6,5 %) ou modérés (2,0 %). Parmi les résultats notables figurent une prise de poids minimale (1,52 kg), l'absence d'événements indésirables graves liés au médicament et des améliorations de plusieurs marqueurs neuro-inflammatoires. Le succès de l'étude soutient le potentiel de la brilaroxazine comme traitement innovant de la schizophrénie, en particulier pour les symptômes négatifs persistants et les mauvais résultats fonctionnels.
Reviva Pharmaceuticals (NASDAQ: RVPH) gab positive Ein-Jahres-Daten aus der offenen Verlängerungsstudie der Phase 3 RECOVER mit Brilaroxazin zur Behandlung von Schizophrenie bekannt. Die Studie zeigte eine anhaltende breit gefächerte Wirksamkeit über alle Symptombereiche hinweg bei einer Abbruchrate von 35 %. Das Medikament führte zu signifikanten Verbesserungen der PANSS-Werte mit einer Gesamtscore-Verbesserung von -10,7 nach 6 Monaten und -18,1 nach 12 Monaten. Sicherheitsdaten zeigten, dass nur 8,5 % der Teilnehmer behandlungsbedingte unerwünschte Ereignisse berichteten, meist mild (6,5 %) oder moderat (2,0 %). Bemerkenswerte Ergebnisse umfassen eine minimale Gewichtszunahme (1,52 kg), keine schwerwiegenden medikamentenbedingten Nebenwirkungen und Verbesserungen mehrerer neuroinflammatorischer Marker. Der Erfolg der Studie unterstützt das Potenzial von Brilaroxazin als neuartige Behandlung der Schizophrenie, insbesondere zur Behandlung persistierender negativer Symptome und schlechter funktionaler Ergebnisse.
Positive
  • Robust efficacy sustained over 1-year across all symptom domains of schizophrenia
  • Low rate of adverse events (8.5%) with mostly mild to moderate severity
  • Significant PANSS total score improvements (-18.1 at 12 months)
  • Minimal weight gain (1.52 kg) over 1-year treatment
  • No drug-related serious adverse events or major safety concerns
  • Improved lipids levels and endocrine hormone levels
Negative
  • 35% treatment discontinuation rate over one year
  • Some mild adverse events including headache (2.7%), insomnia (4.0%), sleep disturbance (2.9%) and mild tremor (3.1%)

Insights

Reviva's brilaroxazine shows sustained efficacy in schizophrenia with impressive safety profile, positioning it well for FDA submission.

The Phase 3 RECOVER open-label extension (OLE) study results for brilaroxazine represent a significant clinical achievement in schizophrenia treatment. The 1-year data demonstrates sustained efficacy across all symptom domains, including the notoriously difficult-to-treat negative symptoms. This is particularly noteworthy as negative symptoms (social withdrawal, apathy, etc.) are poorly addressed by current antipsychotics yet significantly impact patient functionality.

The 35% discontinuation rate is remarkably low for a long-term schizophrenia trial, where rates typically exceed 50%. Even more telling is that only 1.1% discontinued due to treatment-related adverse events, suggesting exceptional tolerability. The minimal weight gain (1.52kg over a year) is substantially better than many approved antipsychotics that cause 7-10kg gains within months.

The improvement in inflammatory markers aligns with emerging research on schizophrenia pathophysiology, suggesting brilaroxazine may address underlying disease mechanisms rather than just symptoms. This could explain the broad efficacy profile.

Importantly, the study satisfied the FDA requirement of long-term safety data from 100 patients completing 1-year treatment, clearing a critical regulatory hurdle for NDA submission. The absence of cardiac, liver, or metabolic safety signals further strengthens the drug's profile.

The consistency between the 4-week double-blind and 52-week open-label data suggests robust and durable treatment effects, addressing a significant unmet need for medications that maintain efficacy while remaining well-tolerated over extended periods.

� Robust broad-spectrum efficacy sustained over 1-year across all symptom domains including negative symptoms �

� Generally well-tolerated with low rates of adverse events and discontinuation �

� Brilaroxazine improved multiple neuroinflammatory markers reported to enhance efficacy and mitigate side effects �

� Virtual investor webcast today at 8:00 a.m. EDT �

CUPERTINO, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- ÌýReviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Revivaâ€� or the “Companyâ€�), 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 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. Once daily brilaroxazine led to robust broad-spectrum efficacy that was sustained over 1-year and was generally well tolerated with a discontinuation rate of 35% in this long-term study. Brilaroxazine is a novel serotonin dopamine signaling modulator with multi-faceted direct and indirect activities on critical pathways implicated in schizophrenia.ÌýÌýÌý To register for the virtual investor webcast being held today, June 2, 2025 at 8:00 a.m. EDT regarding the OLE trial data, please visit .

“We are pleased to complete the positive registrational trial for our brilaroxazine program in schizophrenia and generate long-term data reinforcing brilaroxazine’s consistent, wide-spectrum efficacy, and well-tolerated safety profile,â€� said Laxminarayan Bhat, Ph.D., Founder, President, and CEO ofÌýReviva. “Importantly, the additional multiple biomarker data serve as independent measures of efficacy that further support improvements across all major symptom domains of schizophrenia. Our clinical program continues to advance towards registration, and we look forward to bringing brilaroxazine to more patients globally as fast as possible.â€�

Dr. Stephen R Marder, MD, Professor, Psychiatry and Biobehavioral Sciences at the University of California, Los Angeles added, �Dissatisfaction with current standards of care is largely driven by persistent negative symptoms and poor functional outcomes. The robust improvement in negative symptoms and sustained broad-spectrum efficacy support the potential of brilaroxazine to address these unmet needs.�

Dr. Larry Ereshefsky, PharmD, BCPP, FCCP, Retired Professor of Psychiatry, Pharmacology and Psychiatry, The University of Texas added, “Brilaroxazine improved multiple biomarkers including reduced levels of inflammatory cytokines that could contribute to enhanced efficacy and mitigate side effects. The impact of reduced inflammation on symptoms may result in improved patient adherence and clinical outcomes. The low discontinuation rates observed in the double-blind and OLE trials are consistent with this beneficial treatment profile.�

Key safety, efficacy and compliance findings for pooled analysis of brilaroxazine (n = 446) at 15 mg (n = 140), 30 mg (n = 158), and 50 mg (n = 148) include: Dose-dependent, broad spectrum, clinically meaningful and sustained long-term (1-year) efficacy across all major symptom domains of schizophrenia.

Point Improvement from Baseline to End of Treatment for Brilaroxazine Pooled (15, 30, and 50 mg) at 6-month and 12-month, pÌýÌý 0.001
ÌýOLE at 6-month
(N=303)
OLE at 12-month
(N=159)
Rollover Patients,
Double-blind to
OLE at 13-month

(N=50)
PANSS Total Score-10.7Ìý-18.1Ìý-47.7Ìý
Positive Symptoms-3.3Ìý-5.0Ìý-14.0Ìý
Negative Symptoms-2.8Ìý-4.4Ìý-10.5Ìý
Negative Marder Factor-3.0Ìý-4.4Ìý---Ìý
PANSS Social Cognition-1.5Ìý-2.9Ìý---Ìý
Personal and Social Performance4.5Ìý11.3Ìý32.7Ìý
CGI-S score >1-point37.3%Ìý58.5%Ìý100%Ìý
PANSS Excitement/Agitation-1.4Ìý-3.5Ìý---Ìý
PANSS General Psychopathology-4.7Ìý-8.7Ìý23.2Ìý

PANSS: Positive and Negative Syndrome Scale; CGI-S: Clinical Global Impression - Severity


Clinical safety, tolerability and adherence findings with pooled doses of brilaroxazine (15, 30, and 50 mg) in the OLE trial patients (N=446) support a well-tolerated safety profile:

  • 8.5% of participants reported at least one treatment-emergent adverse event (TEAE), which were mostly mild (6.5%) or moderate (2.0%) in severity and transient in nature
  • Most common TEAEs 2% were headache (2.7%), insomnia (4.0%), sleep disturbance (2.9%) and mild tremor (3.1%)
  • Brilaroxazine was not associated with any clinically meaningful changes in movement disorder scales used for evaluating motor side effects such as akathisia and extrapyramidal symptoms over 1-year treatment
  • Mild weight gain (1.52 kg) reported in the pooled brilaroxazine dose group over 1-year treatment. Weight gain was not dose dependent with least weight gain (1.28 kg) at 50 mg dose
  • No drug related serious adverse events (SAEs) observed or major safety concerns reported for brilaroxazine after 1-year of treatment; 5 serious adverse events were reported, and none were related to brilaroxazine treatment
  • No incidence of clinically significant cardiac side effects, or gastrointestinal side effects
  • No incidence of drug induced liver injury (DILI)
  • No significant change in blood glucose levels
  • Improved lipids levels and endocrine hormone levels (prolactin, and thyroid)
  • Treatment discontinuation rate of 35% reported in this one-year study primarily due to withdrawal of consent (22%), participant lost to follow up (7%) and treatment related adverse events (1.1%)

We believe that collectively, the Phase 3 RECOVER OLE study (52-week/1-year) findings further strengthen the safety, efficacy and treatment adherence findings in the Phase 3 RECOVER double-blind study (4-week).

The is a global, open-label, multicenter study to assess the safety, tolerability and efficacy of brilaroxazine at flexible doses of 15, 30 or 50 mg, administered once daily for 52-week (1-year) in patients with stable schizophrenia. The OLE study included both rollover participants from the RECOVER double-blind study and de novo participants with stable schizophrenia. Long-term safety data from 100 patients who have completed 1-year of treatment is a requirement for brilaroxazine’s NDA submission to the U.S. Food and Drug Administration (“FDAâ€�).Ìý

Webcast Information
To register for the virtual investor webcast being held today, June 2, 2025 at 8:00 a.m. EDT regarding the OLE trial data, please visit . Subsequent to today’s live webcast, a replay will be made available on Reviva’s website at https://revivapharma.com/events. The archived version of the webcast will be available on the Company’s website for at least 30 days.

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 ratesÌýlowerÌýthan 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 visitÌý.

About RevivaÌý
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 anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development, clinical and regulatory timelines and expenses, planned or additional studies, planned or intended regulatory submissions, the timing of availability of additional data or initiation of additional trials, market opportunity, ability to raise sufficient funding, 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 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, 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

Investor Relations Contact:
LifeSci Advisors, LLC
Bruce Mackle


FAQ

What were the main results of RVPH's Phase 3 RECOVER trial for brilaroxazine?

The trial showed sustained efficacy over 1 year with significant improvements in PANSS scores (-18.1 at 12 months), low adverse event rates (8.5%), and minimal weight gain (1.52 kg).

How safe is brilaroxazine based on the Phase 3 trial results?

Brilaroxazine showed a favorable safety profile with 8.5% treatment-emergent adverse events, mostly mild, no drug-related serious adverse events, and no significant cardiac or gastrointestinal side effects.

What is the discontinuation rate for RVPH's brilaroxazine in the Phase 3 trial?

The study reported a 35% discontinuation rate over one year, primarily due to withdrawal of consent (22%), loss to follow-up (7%), and treatment-related adverse events (1.1%).

How does brilaroxazine affect negative symptoms of schizophrenia?

The drug demonstrated robust improvement in negative symptoms with a -4.4 point improvement in negative symptoms at 12 months, addressing a key unmet need in schizophrenia treatment.

What are the next steps for RVPH's brilaroxazine development?

The company is advancing towards registration and NDA submission to the FDA, having met the requirement of long-term safety data from 100 patients completing 1-year of treatment.
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