Mihael Polymeropoulos on FDA approval
From Vanda Pharmaceuticals Q4 2025 Earnings Call · · Investing 101
“We achieved a major regulatory win with the FDA approval of Nourianz in late 2025 for the prevention of vomiting induced by motion. The first new oral pharmacologic option in this space in over 40 years. This approval opens a substantial market opportunity in motion sickness. Motion sickness is a common condition with prevalence estimates indicating that approximately 25 to 30% of US adults, roughly 65 to 78 million people, experience symptoms during travel or motion exposure.”
On , Mihael Polymeropoulos, Founder, President, Chief Executive Officer & Chairman of The Board at VANDA PHARMACEUTICALS INC, spoke about FDA approval during Vanda Pharmaceuticals Q4 2025 Earnings Call on Investing 101.
About Mihael Polymeropoulos
In September 2020, Polymeropoulos discussed Vanda Pharmaceuticals' efforts to address the COVID-19 pandemic. He described the company's "Odyssey study," a phase 3 clinical trial of the drug tradipitant in approximately 300 hospitalized patients with COVID-19 pneumonia. Polymeropoulos stated that the study aimed to "stop the inflammation that advances to severe acute respiratory distress syndrome" and that if enrollment was completed quickly, results could be available within two months. He said that if successful, the company would ask the FDA for accelerated approval. Polymeropoulos also noted that Vanda was pursuing a comprehensive program including the development of antivirals and a vaccine in collaboration with the University of Illinois in Chicago, as well as a genetic variation study of COVID-19 with the University of Washington. He described the FDA as "very cooperative" in responding to projects and urged caution against "over-indexing" on any single approach, stating that "the solution is not going to be just a wonderful vaccine 12 to 18 months from now." In a 2015 acceptance speech for an industry innovation award, Polymeropoulos said his "personal inspiration comes truly from patients with rare orphaned disorders." He recounted his formative career at the National Institutes of Health mapping disease genes and discussed the development of Hetlioz, a medication for non-24-hour sleep-wake disorder in blind individuals, which he said allows them to "reset their circadian timing system." He thanked patients, advocacy organizations, the FDA, and legislators for their work in improving research.