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Milestone Pharmaceuticals Inc. (NASDAQ:MIST) announced on Friday that its New Drug Application for CARDAMYST (etripamil) nasal spray, aimed at treating acute episodes of paroxysmal supraventricular tachycardia, received a Complete Response Letter from the U.S. Food and Drug Administration (FDA).
The company’s shares are trading lower following the news.
While the FDA did not raise concerns about the clinical safety or efficacy of etripamil, it highlighted two critical issues related to Chemistry, Manufacturing, and Controls.
The FDA requested additional information on nitrosamine impurities based on newly issued draft guidance, which was released after the NDA submission.
Additionally, the agency called for an inspection of a facility that conducts release testing for etripamil, to ensure compliance with Current Good Manufacturing Practices.
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This facility had changed ownership during the NDA review process.
Despite the setback, Milestone Pharmaceuticals said that it remains committed to CARDAMYST as a potential treatment for PSVT.
CEO Joe Oliveto expressed disappointment but emphasized the company’s intention to request a Type A meeting with the FDA to address the raised issues and continue pursuing resubmission.
“We are appreciative of the FDA’s efforts and are confident we can collaborate with the agency with the goal of addressing these issues in a resubmission,” said Oliveto.
As of December 31, 2024, the company reported having $69.7 million in cash and short-term investments.
Price Action: MIST shares are trading lower by 62.1% to $0.8533 at last check Friday.
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Posted In: MIST
