Milestone Pharmaceuticals Receives EMA Acceptance for Etripamil Nasal Spray

MONTREAL and CHARLOTTE, N.C., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) seeking the approval of etripamil nasal spray, developed to be the first rapid, reliable option in the treatment of paroxysmal supraventricular tachycardia (PSVT) outside of the healthcare setting. Etripamil, which has the conditionally approved brand name TACHYMIST™ in Europe, is an investigational, novel calcium channel blocker delivered via a nasal spray by the patient for the potential treatment of PSVT and other cardiac arrhythmias. A decision on approval is expected by the first quarter of 2027.

Milestone Pharmaceuticals has made a significant announcement regarding the acceptance of its Marketing Authorization Application (MAA) for Etripamil Nasal Spray by the European Medicines Agency (EMA). Etripamil is a novel treatment option being developed for patients suffering from Paroxysmal Supraventricular Tachycardia (PSVT), a condition that typically leads to episodes of rapid heart rate causing discomfort and complications in daily life.

The acceptance of the MAA marks a pivotal step in Milestone's ongoing efforts to bring this potentially life-changing medication to market. Etripamil nasal spray is designed to provide rapid and on-demand termination of PSVT episodes, which could greatly enhance the quality of life for patients who frequently experience these episodes.

This development underscores Milestone Pharmaceuticals' commitment to addressing unmet medical needs in cardiovascular health. The company is dedicated to innovative therapeutic solutions that empower patients to manage their conditions more effectively. The EMA's acceptance of the application indicates a rigorous evaluation process that could lead to approval and subsequent availability of Etripamil for patients across Europe.

PSVT affects a substantial number of individuals, often leading to emergency interventions. Currently, treatment options are limited, which highlights the importance of introducing a non-invasive, easy-to-administer solution like Etripamil nasal spray. This product could lead to fewer emergency room visits and lessen the overall burden on healthcare systems.

As the review process unfolds, Milestone anticipates continuing discussions with both the EMA and stakeholders to optimize the development and deployment strategies for Etripamil. The company is hopeful that positive outcomes from the review could accelerate access for patients who need this treatment.

In summary, the acceptance of the MAA by the EMA is a crucial milestone for Milestone Pharmaceuticals, bringing them one step closer to fulfilling their mission of delivering effective solutions for patients with PSVT. The upcoming regulatory process will be closely monitored by industry experts and patients alike, all eager to see how this innovative treatment can change the landscape of PSVT management.