Milestone Pharma: FDA Issues CRL Regarding New Drug Application For CARDAMYST Nasal Spray

(RTTNews) - Milestone Pharmaceuticals (MIST) announced the FDA issued a Complete Response Letter regarding its New Drug Application for CARDAMYST nasal spray, a prescription medication in development for the conversion of acute episodes of PSVT to sinus rhythm in adults. The FDA highlighted two key Chemistry, Manufacturing and Controls issues to be addressed.

"Our team is evaluating the feedback provided and intends to request a Type A meeting to discuss the issues raised in the CRL," said Joe Oliveto, President and CEO of Milestone Pharmaceuticals.

Milestone Pharmaceuticals had $69.7 million in cash, cash equivalents and short-term investments as of December 31, 2024.

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