MIST Stock Soars Pre-Market After FDA Approves First Commercial Product – Retail Remains Bullish, Dismisses ‘Sell The News’ Concerns

• Milestone announced that the FDA approved Cardamyst, a novel nasal spray designed to rapidly resolve episodes of Paroxysmal Supraventricular Tachycardia and restore sinus rhythm.
• The nasal spray can be self-administered by patients outside the emergency department or other healthcare settings, the company said.
• Milestone expects Cardamyst to be available for purchase at retail pharmacies in the first quarter of 2026.

Shares of Milestone Pharmaceuticals Inc. (MIST) rose nearly 32% in Monday’s pre-market after the company received approval from the U.S. Food and Drug Administration (FDA) for its first commercial product late Friday.

Milestone announced that the FDA approved Cardamyst, a novel nasal spray designed to rapidly resolve episodes of Paroxysmal Supraventricular Tachycardia (PSVT) and restore sinus rhythm.

Retail sentiment on Stocktwits around Milestone stock trended in the ‘extremely bullish’ territory, while message volumes were at ‘extremely high’ levels at the time of writing.

Cardamyst Approval

Milestone stated in its announcement that the approval of Cardamyst opens up an addressable market of more than two million Americans who suffer from PSVT. The nasal spray can be self-administered by patients outside the emergency department or other healthcare settings, the company said.

Milestone expects Cardamyst to be available for purchase at retail pharmacies in the first quarter (Q1) of 2026.

“Cardamyst is a novel at-the-ready treatment option that addresses the unpredictable impact of PSVT by offering patients the freedom to manage episodes anytime and anywhere,” said Joseph Oliveto, CEO, Milestone Pharmaceuticals.

Clinical Data

Milestone stated that Cardamyst’s approval by the FDA is based on safety data from more than 1,800 participants and over 2,000 episodes of PSVT.

The company said that participants using Cardamyst were twice as likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster than with a placebo.

Retail Optimistic

Retail users on Stocktwits expressed their optimism around the company and Cardamyst following the FDA approval.

One user said that the most challenging part for the company was over after the approval, adding that those who are long on the stock have “ZERO to worry about here.”

Another user dismissed concerns that this is a “sell the news” event, adding that they are “waiting with 0 worries.”

MIST stock is up 2% year-to-date and 30% over the past 12 months.

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