The stock of Milestone Pharmaceuticals is witnessing a significant downturn on Tuesday morning following the issuance of a refusal to file letter from the Food and Drug Administration (FDA). Having concluded Friday’s trading session at $2.88, the stock commenced post-Christmas trading on Tuesday at $2.00, indicating a continued decline.
At the time of this publication, Tesla Inc stock (MIST) has witnessed a decline.
MIST
Milestone Pharmaceuticals Inc
Current Price: $1.89
Change : -0.99
Change (%): (-34.37%)
Volume: 1.6M
Source: Tomorrow Events Market Data
The biopharmaceutical company revealed that it had received the FDA letter in response to its new drug application for its etripamil nasal spray, intended for the treatment of a type of abnormal heart rhythm. According to Milestone Pharmaceuticals, the FDA found the application for etripamil nasal spray, as a treatment for paroxysmal supraventricular tachycardia, to be insufficiently complete for a substantive review based on a preliminary assessment.
The FDA, in its communication, sought clarification from Milestone regarding the timing of data recorded for adverse events in Phase 3 clinical trials, as reported by the company. Milestone Pharmaceuticals emphasized that the regulator did not express concerns about the nature or severity of adverse events in its preliminary assessment.
In response to the FDA’s refusal to file, Milestone Pharmaceuticals announced its intention to seek clarification and revealed plans to schedule a meeting with the FDA to address the concerns raised. The company is committed to resolving the issues and ensuring the completeness of its application for etripamil nasal spray.
The impact of the FDA’s decision is reflected in Milestone Pharmaceuticals’ recent stock performance:
– 5 Day Performance: -31.82%
– 1 Month Performance: -33.27%
– 3 Month Performance: -37.50%
– Year-to-Date (YTD) Performance: -52.65%
– 1 Year Performance: -50.40%
Investors are closely monitoring the situation as Milestone Pharmaceuticals navigates the regulatory challenges associated with its new drug application. The decline in stock value underscores the significance of regulatory outcomes in the pharmaceutical industry and the potential impact on stakeholders. The company remains focused on addressing the FDA’s concerns and working towards a resolution to move forward with its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia.
