FDA Rejects Milestone Pharma's Heart Drug Application Amid Manufacturing Concerns

Milestone Pharmaceuticals faced a setback as the FDA declined to approve its nasal spray Cardamyst (etripamil) for treating paroxysmal supraventricular tachycardia (PSVT), citing chemistry, manufacturing, and controls issues without questioning clinical safety or efficacy. The FDA highlighted concerns about nitrosamine impurities and the need for an inspection of a testing facility associated with the drug. Despite the rejection, Milestone plans to address these issues and intends to request a Type A meeting with the FDA for further discussion. The company remains committed to developing Cardamyst as a novel treatment for PSVT. Currently, Milestone holds $69.7 million in cash and investments, which positions it to navigate this challenge. The stock has seen a price increase of 25% over the last year, reflecting some investor confidence despite the regulatory hurdle.