Analyst Brandon Folkes of H.C. Wainwright reiterated a Buy rating on Milestone Pharmaceuticals, retaining the price target of $5.00.
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Brandon Folkes has given his Buy rating due to a combination of factors that suggest a favorable outcome for Milestone Pharmaceuticals. The imminent PDUFA date presents a compelling risk/reward opportunity, as the market appears to have misunderstood the implications of the February 2025 Complete Response Letter (CRL). Folkes’s analysis indicates that the CRL was not a reflection of concerns about Cardamyst’s safety or efficacy, but rather a procedural issue related to updated FDA guidance on nitrosamines, which has since been addressed.
Folkes believes there is a high likelihood of Cardamyst’s approval on December 13, which could act as a significant catalyst for re-rating the stock. The CRL was primarily due to the timing of new FDA guidance on nitrosamine testing, not due to any inherent safety issues with the drug. Additionally, the structural properties of etripamil, the active ingredient in Cardamyst, make it less likely to form harmful nitrosamines, supporting the expectation of a positive outcome. This analysis, combined with Milestone’s prompt resubmission following a Type A meeting, suggests a clear path to approval.