Milestone Pharma hits record low after FDA declines to approve heart rhythm nasal spray

Milestone Pharmaceuticals

28/03/2025 16:25

Updates

** Shares of drug developer Milestone Pharmaceuticals MIST.O fall as much as 66.7% to record low of 75 cents

** Stock down 59% at 92 cents in afternoon trade

        ** 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

** Including session moves, stock down 60% YTD

 (Reporting by Kamal Choudhury in Bengaluru)

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