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Milestone Pharmaceuticals Submits Response to FDA for CARDAMYST

Story Highlights
  • Milestone Pharmaceuticals submitted a response to the FDA’s CRL for CARDAMYST nasal spray.
  • If approved, CARDAMYST will be the first self-administered therapy for PSVT, enhancing patient control.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Milestone Pharmaceuticals Submits Response to FDA for CARDAMYST

Elevate Your Investing Strategy:

An update from Milestone Pharmaceuticals ( (MIST) ) is now available.

On June 16, 2025, Milestone Pharmaceuticals announced the submission of its response to the FDA’s Complete Response Letter regarding its New Drug Application for CARDAMYST (etripamil) nasal spray, intended for managing paroxysmal supraventricular tachycardia (PSVT). This submission follows a productive Type A meeting with the FDA, and the company anticipates a new Prescription Drug User Fee Act (PDUFA) date within the year. If approved, CARDAMYST would be the first self-administered therapy for rapid termination of PSVT episodes, potentially enhancing patient self-management and control over their condition.

The most recent analyst rating on (MIST) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on Milestone Pharmaceuticals stock, see the MIST Stock Forecast page.

Spark’s Take on MIST Stock

According to Spark, TipRanks’ AI Analyst, MIST is a Underperform.

Milestone Pharmaceuticals’ overall stock score reflects substantial financial difficulties, including no revenue and negative cash flows. However, the upcoming launch of CARDAMYST provides a potential turnaround opportunity, which is a significant positive factor. Technical indicators suggest a bearish trend, and valuation metrics highlight the lack of earnings and dividends, indicating a speculative investment.

To see Spark’s full report on MIST stock, click here.

More about Milestone Pharmaceuticals

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company focused on developing and commercializing innovative cardiovascular solutions. The company aims to improve the lives of individuals with complex heart conditions by developing treatments that allow patients to actively manage their care. Their lead investigational product is etripamil, a novel calcium channel blocker nasal spray designed for self-administration to treat symptomatic episodic attacks associated with PSVT and AFib-RVR.

Average Trading Volume: 2,332,139

Technical Sentiment Signal: Sell

Current Market Cap: $88.22M

Find detailed analytics on MIST stock on TipRanks’ Stock Analysis page.

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