Milestone Pharmaceuticals Inc. 8-K

What Happened

• Milestone Pharmaceuticals, Inc. (MIST) filed a Form 8-K on January 6, 2026 announcing that the European Medicines Agency (EMA) has accepted the company’s Marketing Authorization Application (MAA) seeking approval of etripamil nasal spray.
• The filing states a regulatory decision from the EMA is expected by the first quarter of 2027. A press release dated January 6, 2026 is attached as Exhibit 99.1 to the 8-K.

Key Details

• Filing date: January 6, 2026 (Form 8-K, Item 8.01).
• Product: etripamil nasal spray (MAA submitted to EMA).
• Expected EMA decision timing: by Q1 2027.
• Press release included as Exhibit 99.1 to the 8-K.

Why It Matters

• This is a formal regulatory milestone: EMA acceptance of an MAA means the agency will conduct a full review of etripamil for potential approval in the European Union, not that approval has been granted.
• For investors, a favorable EMA decision could clear the way for commercialization in Europe and become a material driver of future revenue; the Q1 2027 timeline provides a near-term regulatory milestone to watch.
• The 8-K flags the company’s progress through the regulatory process and gives shareholders a clear update and timeline without making operational or financial claims.