Reviva Pharmaceuticals (US:RVPH) Globenewswire·2025-11-13 21:05Core Insights - Reviva Pharmaceuticals is preparing for a pre-New Drug Application (NDA) meeting with the FDA in Q4 2025, targeting a potential NDA submission for brilaroxazine for schizophrenia in Q2 2026 [1][2] - The company has received a European patent for brilaroxazine's use in treating pulmonary fibrosis, adding to its existing patent protections in major markets [1][3] - Brilaroxazine has shown promising results in clinical trials, demonstrating broad-spectrum efficacy and a favorable safety profile [2][3] Clinical Program and Business Highlights - The European Patent Office granted a patent (EP3749324) for brilaroxazine's use in pulmonary fibrosis, complementing existing protections in the US, China, and Japan [3] - Brilaroxazine received Orphan Drug Designation from the FDA for treating idiopathic pulmonary fibrosis in July 2024 [3] - A Phase 3 study showed that once-daily brilaroxazine led to significant improvements in various psychiatric symptoms over one year, with a total PANSS score reduction of 18.1 [3] - The treatment was well-tolerated, with no significant movement disorders or clinically meaningful side effects reported [3] - Weight gain was benign at approximately 1.5 kg over 52 weeks, and improvements in lipid profiles and blood sugar levels were noted [3] Financial Results - For the three months ended September 30, 2025, the company reported a net loss of approximately $4.0 million, or $0.06 per share, compared to a net loss of $8.4 million, or $0.25 per share, for the same period in 2024 [9][14] - As of September 30, 2025, cash and cash equivalents totaled approximately $13.2 million, a slight decrease from $13.5 million at the end of 2024 [9][11] Anticipated Milestones and Events - The company plans to submit an investigational new drug application (IND) for a liposomal-gel formulation of brilaroxazine for psoriasis by H2 2026 [9] - Reviva is actively pursuing partnership opportunities for the development of its pipeline [9]