Milestone flagging following CRL
Cardiovascular-focused Milestone Pharmaceuticals (Nasdaq: MIST) was trading more than 60% lower early in trading on Friday, with its share price worth less than $0.90.
This followed Milestone announcing that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in relation to the company’s New Drug Application (NDA) for Cardamyst (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
Milestone has stressed that the FDA did not raise any concerns regarding the clinical safety or efficacy data of what is its lead investigational product. Instead, the agency highlighted two key Chemistry, Manufacturing and Controls issues to be addressed.
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