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Reviva Reports Third Quarter 2025 Financial Results and Recent Business Highlights

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  • Reviva Pharmaceuticals plans a pre-NDA meeting with the FDA in Q4 2025 to discuss brilaroxazine's path to approval for schizophrenia.
  • The company targets a potential NDA submission for brilaroxazine in the schizophrenia indication for Q2 2026.
  • The European Patent Office granted patent EP3749324 covering brilaroxazine for treating pulmonary fibrosis, adding to existing protections in the US, China, Japan.
  • Phase 3 RECOVER open-label extension study results showed sustained broad-spectrum efficacy over one year with no clinically meaningful changes in movement disorder scales.
  • Long-term safety data indicated benign weight gain of approximately 1.5 kg, favorable lipid profiles, comparable blood sugar levels, no significant cardiac or gastrointestinal side effects.
  • The company reported a net loss of approximately $4.0 million ($0.06 per share) for the three months ended September 30, 2025, compared to $8.4 million in the prior year period.
  • Cash cash equivalents totaled approximately $13.2 million as of September 30, 2025.
  • Reviva completed a public equity offering raising gross proceeds of $9.0 million.
  • The company presented negative symptom data for brilaroxazine at the CNS Summit in November 2025 is scheduled to present anti-inflammatory biomarker data at the Society for Neuroscience Annual Meeting later that month.
  • An IND submission for a liposomal-gel formulation of brilaroxazine in psoriasis is expected in the second half of 2026.
  • The company continues to pursue partnership opportunities for its pipeline development.