Milestone Pharmaceuticals (MIST): FDA Approval Is Done — So Why Is the Stock Acting Dead?

Milestone Pharmaceuticals has already cleared the hurdle that destroys most small biotechs: FDA approval. Yet the stock continues to drift quietly, as if nothing happened. That disconnect is exactly what makes MIST worth another look.

In December 2025, Milestone Pharmaceuticals received FDA approval for CARDAMYST™, a self-administered nasal spray designed to treat acute episodes of paroxysmal supraventricular tachycardia (PSVT). Unlike traditional hospital-based treatments, CARDAMYST is meant to be used at home, allowing patients to potentially stop an episode without an emergency room visit. That delivery model is the core of Milestone’s value proposition.

This approval did not come easily. Earlier in 2025, the FDA issued a Complete Response Letter that sent the stock into freefall. Importantly, those issues were tied to manufacturing and chemistry controls, not drug safety or efficacy. Once those hurdles were addressed, the FDA signed off. The market now has a clear answer to the most important question: the drug works, and it meets regulatory standards.

So why does the stock still trade near two dollars?

The answer appears to be less about fundamentals and more about psychology. MIST ran hard into the approval event and sold off once the binary risk was removed. Since then, it has settled into a narrow trading range, with volume drying up rather than accelerating lower. This kind of post-event consolidation is common in biotech, especially when the story transitions from speculation to execution.

Concerns about dilution have also surfaced, but context matters. The company recently disclosed stock option grants to newly hired employees under Nasdaq’s inducement rule. These options vest over multiple years and do not immediately increase the share count. While they represent potential future dilution, the scale is modest and, importantly, there has been no sign of aggressive share issuance or financing pressure in the market. If dilution were actively hitting, the chart would look very different.

Beyond PSVT, Milestone is attempting to expand the same nasal spray technology into atrial fibrillation with rapid ventricular rate (AFib-RVR), a larger potential market. This program remains investigational and should be viewed as upside optionality rather than a core part of the valuation today. Still, it provides a second path forward if execution continues.

From a technical perspective, MIST is behaving like a stock that is waiting, not failing. Support has held in the mid-$1.80s, while resistance sits just above $2.00. A move through that level could quickly shift sentiment, while a breakdown below support would invalidate the thesis. For now, the market appears undecided, not bearish.

Milestone Pharmaceuticals is no longer a regulatory gamble. It is now a commercial story, and those stories often take time to be understood. The stock may look boring, but boring after FDA approval is often where opportunity begins — provided investors are willing to manage risk and remain patient.

In addition to the U.S. approval, Milestone has also taken meaningful steps toward expanding CARDAMYST into Europe, which adds an underappreciated layer of upside. The company has announced that its European regulatory application has been accepted for review, opening the door to commercialization across multiple EU markets if approved. While Europe often moves more slowly than the FDA, successful authorization would significantly broaden the drug’s addressable patient base and reduce reliance on a single geography. For a company of Milestone’s size, European approval would not just be incremental revenue — it would meaningfully change the scale of the commercial opportunity.

Importantly, this potential expansion is not being priced into the stock today. With shares still trading near post-approval lows, the market appears focused almost entirely on near-term U.S. execution while discounting international growth altogether. If Milestone demonstrates early prescription traction domestically while advancing its European rollout, that narrative gap could begin to close.

From a balance-sheet perspective, Milestone Pharmaceuticals enters its post-approval phase with a manageable cash position, giving the company a runway to execute its initial commercial launch without immediate financing pressure. While the market remains sensitive to dilution risk across small-cap biotech, Milestone’s near-term focus is now squarely on commercialization rather than survival. Investors will be watching operating burn closely as CARDAMYST begins its rollout, but at current levels, the company appears positioned to fund early launch activities while it works to prove real-world demand and payer adoption.

Milestone Pharmaceuticals is currently trading around $1.97, consolidating near the lower end of its historical range after a volatile year. Over the past 52 weeks, the stock has traded between a low of $0.63 and a high of $3.06, underscoring both its downside risk and rebound potential. With a market capitalization of approximately $168 million and average daily trading volume near 5.3 million shares, MIST remains an actively followed small-cap biotech. Analyst sentiment skews bullish: Wells Fargo, TD Cowen, and H.C. Wainwright all carry Buy/Overweight ratings with $8.00 price targets, reflecting confidence in the company’s clinical trajectory, while Jefferies maintains a more cautious Hold rating with a $2.00 target. Collectively, these forecasts result in an average one-year analyst price target of $6.60, implying substantial upside from current levels if execution and catalysts align.

MIST may look quiet now, but post-approval biotechs rarely reward impatience — they reward execution.

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Disclaimer: This content is for informational and educational purposes only and does not constitute financial or investment advice. All opinions expressed are personal and subject to change. Investors should conduct their own research and consult a qualified financial professional before making any investment decisions.