Zevra Therapeutics(US:ZVRA) Globenewswireยท2025-11-05 21:05Core Insights - Zevra Therapeutics reported a net revenue of $26.1 million for Q3 2025, significantly up from $3.7 million in Q3 2024, primarily driven by MIPLYFFA net revenue of $22.4 million [2][6][31] - The company is focused on expanding its presence in the rare disease market, particularly through the strong performance of MIPLYFFA for Niemann-Pick disease type C [3][28] Financial Highlights - Q3 2025 net revenue was $26.1 million, including $22.4 million from MIPLYFFA, $0.1 million from OLPRUVA, and $2.4 million in net reimbursements from the French EAP for arimoclomol [6][31] - Operating expenses for Q3 2025 were $20.4 million, down from $27.2 million in Q3 2024, with R&D expenses decreasing to $3.4 million from $10.9 million [11][31] - The net loss for Q3 2025 was $(0.5) million, or $(0.01) per share, compared to a net loss of $(33.2) million, or $(0.69) per share, in Q3 2024 [11][31] Product Performance - MIPLYFFA has achieved a market access rate of 66% of covered lives, with 137 prescription enrollment forms submitted since its launch [7] - OLPRUVA has reached an 81% market access rate, with 30 prescription enrollment forms submitted [7] - The company is evaluating options for OLPRUVA while maintaining product availability and support services for patients [7] Pipeline and Innovation - A Marketing Authorization Application for arimoclomol for Niemann-Pick disease type C has been validated and is under review by the European Medicines Agency [7] - Celiprolol, an investigational candidate for Vascular Ehlers-Danlos Syndrome, has restarted enrollment in the Phase 3 DiSCOVER trial [27] Cash Position - As of September 30, 2025, the company had cash, cash equivalents, and securities totaling $230.4 million, indicating sufficient financial resources to execute strategic priorities [11][31]