Milestone Pharma slumps after FDA declines to approve heart rhythm nasal spray

Milestone Pharmaceuticals

28/03/2025 11:46

** Shares of drug developer Milestone Pharmaceuticals MIST.O fall 62.7% to 84 cents premarket

** US FDA declined to approve MIST's nasal spray, Cardamyst, to treat a type of heart condition, company says

** FDA raised no concerns about clinical safety or efficacy, but highlighted two key chemistry, manufacturing and controls issues - MIST

** Issues include needing additional information on nitrosamine impurities, cancer-causing compounds formed during manufacturing and an inspection of a testing facility

** Shares up 25% in the last 12 months, as of last close

 (Reporting by Kamal Choudhury in Bengaluru)

 ((Kamal.Choudhury@thomsonreuters.com;))