Milestone Pharmaceuticals’ Path to Approval: Addressing CMC Issues for Cardamyst’s Market Potential

Brandon Folkes, an analyst from H.C. Wainwright, has initiated a new Buy rating on Milestone Pharmaceuticals (MIST).

Brandon Folkes’s rating is based on the potential of Milestone Pharmaceuticals’ drug, Cardamyst, to significantly impact the treatment of paroxysmal supraventricular tachycardia (PSVT). The drug could reduce emergency room visits, with peak sales potentially exceeding $700 million if approved. Despite receiving a Complete Response Letter (CRL) from the FDA, Milestone has outlined steps to address the issues, and a Type A meeting with the FDA has been requested to discuss these steps.
The CRL did not raise efficacy or safety concerns but highlighted two Chemistry, Manufacturing, and Controls (CMC) issues. Milestone is actively working on resolving these, including gathering necessary data on nitrosamine impurities. The outcome of the Type A meeting is expected to provide clarity and could act as a catalyst for the stock. Additionally, resolving the inspection issue, which is seen as a technicality, could further lift uncertainties surrounding the stock. Folkes believes that if Milestone can align with the FDA, there is a clear path to approval and significant value creation.

Folkes covers the Healthcare sector, focusing on stocks such as Trevi Therapeutics, Cormedix, and Milestone Pharmaceuticals. According to TipRanks, Folkes has an average return of -7.0% and a 32.93% success rate on recommended stocks.