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Investing.com -- Milestone Pharmaceuticals Inc . (NASDAQ:MIST) shares plummeted 60% following a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray. The FDA’s letter, which is a setback for the drug designed to treat paroxysmal supraventricular tachycardia (PSVT), highlighted two main issues related to Chemistry, Manufacturing and Controls (CMC) that the company must address.
The FDA’s concerns did not pertain to the clinical safety or efficacy of etripamil but rather focused on additional information required on nitrosamine impurities and an inspection of a facility involved in release testing for the drug, which recently underwent a change in ownership. This facility inspection is necessary to ensure compliance with Current Good Manufacturing Practices.
Milestone (WA:MMD)’s President and CEO, Joe Oliveto, expressed the company’s disappointment with the CRL but reaffirmed their commitment to CARDAMYST as a potential novel treatment for PSVT. The company is planning to request a Type A meeting with the FDA to discuss the issues raised and strategize a path forward for resubmission.
The company, which reported having $69.7M in cash, cash equivalents, and short-term investments as of December 31, 2024, is now faced with the challenge of addressing the FDA’s concerns. Etripamil, Milestone’s leading investigational product, is a calcium channel blocker nasal spray that has completed Phase 3 clinical trials for PSVT and Phase 2 trials for atrial fibrillation with a rapid ventricular rate (AFib-RVR). It is designed to be self-administered, providing patients with the ability to manage acute episodes of these conditions without immediate medical intervention.
As the company works to resolve the FDA’s CRL issues, investors will be closely monitoring Milestone’s progress and any further communications from the regulatory agency. The outcome of the planned Type A meeting and subsequent actions will be critical for the future of CARDAMYST and Milestone’s position in the market for self-administered cardiac care solutions.
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