Milestone Pharmaceuticals Inc. Secures FDA Approval for CARDAMYST™ Nasal Spray, Opening a New Therapeutic Frontier

Milestone Pharmaceuticals Inc. (NASDAQ: MIST) achieved a significant regulatory milestone today with the U.S. Food and Drug Administration’s approval of CARDAMYST™ (etripamil), its first self‑administered nasal spray for adults suffering from paroxysmal supraventricular tachycardia (PSVT). The decision marks the first FDA‑approved treatment for PSVT in more than three decades, addressing a condition that affects over two million Americans and often provokes acute, life‑altering symptoms such as palpitations, chest pressure, and fainting.

Product Profile and Clinical Impact

CARDAMYST™ delivers a rapid‑acting calcium channel blocker directly to the nasal mucosa, enabling patients to halt a symptomatic PSVT episode outside of a clinical setting. This mode of administration represents a paradigm shift in arrhythmia management, offering a convenient, on‑demand solution for patients who experience unpredictable, high‑frequency tachycardia events. The approval is expected to create a new, unmet‑need segment in cardiovascular therapeutics, positioning Milestone as a pioneer in self‑administered treatments for rhythm disorders.

Strategic Implications for Milestone

The FDA endorsement confirms the robustness of Milestone’s novel small‑molecule platform and validates its focus on cardiovascular indications. With a market cap of roughly $245 million and a recent trading price of $2.41 (down from a 52‑week high of $3.06), the company’s valuation now reflects the tangible value of a product that can capture a sizable portion of the PSVT market. The company’s Canadian-only sales model will be complemented by a U.S. launch, potentially unlocking new revenue streams and enhancing international exposure.

Milestone’s leadership has emphasized the importance of rapid‑acting, patient‑friendly therapies, and CARDAMYST™ aligns perfectly with this strategic narrative. The approval also strengthens the company’s intellectual property portfolio, reinforcing its competitive moat against larger cardiovascular players.

Outlook and Next Steps

  • Commercial Roll‑out: Milestone is expected to initiate U.S. distribution in the first quarter of 2026, following a coordinated marketing campaign targeting cardiology practices and patient advocacy groups.
  • Pricing and Reimbursement: Early indications suggest that CMS will likely classify CARDAMYST™ under the “rapid‑acting arrhythmia therapy” category, which could facilitate favorable reimbursement rates.
  • Pipeline Synergies: The company’s ongoing development of other calcium‑channel‑blocker–based therapies may benefit from the clinical data and market acceptance generated by CARDAMYST™.

In conclusion, the FDA approval of CARDAMYST™ positions Milestone Pharmaceuticals at the vanguard of innovative cardiovascular care. By delivering a self‑administered, rapid‑acting solution for PSVT, the company is poised to redefine patient experience, secure new revenue channels, and strengthen its standing within the highly competitive health‑care sector.