Zhitong Finance and Economics learned that Canada-based Milestone Pharmaceuticals (MISTUS) announced on Tuesday local time that the U.S. Food and Drug Administration (FDA) rejected the New Drug Application (NDA) for its lead drug candidate Etripamil. As soon as this negative news came out, Milestone's stock price was about 40% in the pre-market of the U.S. stock market.
According to public information, Milestone Pharmaceuticals is a Canadian-based start-up biopharmaceutical company focused on the best programs for cardiovascular disease. Its main product line includes ** drugs for heart disease, in particular etripamil, a nasal spray for ** paroxysmal supraventricular tachycardia. The drug was designed to provide a rapid, non-invasive** approach, but its new drug application was recently rejected by the FDA.
The agency issued a so-called Refusal to Submit (RTF) letter, stating that the company did not provide sufficient trial data to open the review process. The FDA has asked for clear clarification on the exact timing of adverse events recorded in Phase 3 clinical trials.
In October, Montreal, Canada-based Milestone submitted an NDA for Etripamil nasal spray for sudden supraventricular tachycardia, a heart type disease characterized by abnormal heart rhythms.
We intend to continue to work with the FDA to better understand some of the outstanding issues and try to reach a consistent view on the way forward," noted Joseph Oliveto, CEO of Milestone. The company said it is seeking to meet with regulators to further clarify its new drug application decision.