Milestone CRL affirms integrity of clinical data, says H.C. Wainwright

H.C. Wainwright keeps a Buy rating on Milestone Pharmaceuticals (MIST) after the company announced receipt of a complete response letter from the FDA regarding its new drug application for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia. While “disappointed,” the firm says the issues raised were exclusively related to chemistry, manufacturing, and controls, with no concerns cited around the clinical efficacy or safety of etripamil. This reaffirms the integrity of the clinical data, the analyst tells investors in a research note. H.C. Wainwright expects the launch to be delayed until the first half of 2026. Its $25 price target is under review.

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