EMA accepts Milestone Pharmaceuticals (NASDAQ: MIST) etripamil spray MAA

Rhea-AI Filing Summary

Milestone Pharmaceuticals Inc. reported that the European Medicines Agency has accepted its Marketing Authorization Application for etripamil nasal spray. This step means the European regulator has agreed to formally review the company’s request to market the drug.

The company noted that a decision on approval of etripamil nasal spray is expected by the first quarter of 2027, giving a clear timeline for when the European outcome should be known.

Insights

Biopharma regulatory analyst

EMA acceptance starts formal review of Milestone’s etripamil nasal spray, with an approval decision expected by early 2027.

Milestone Pharmaceuticals Inc. disclosed that the European Medicines Agency has accepted its Marketing Authorization Application for etripamil nasal spray. Acceptance indicates the submission passed the agency’s initial screening and has moved into full scientific review, a key regulatory milestone for any drug seeking access to the European market.

The company also stated that a decision on approval is expected by the first quarter of 2027, giving a defined window for the outcome of this process. Actual impact will depend on the EMA’s final decision and any conditions it may impose, which are not described here and will be known only once the review is completed.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

January 6, 2026

MILESTONE PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

Québec		001-38899		Not applicable
(state or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

1111 Dr. Frederik-Philips Boulevard,
Suite 420
Montréal, Québec CA		H4M 2X6
(Address of principal executive offices)		(Zip Code)

Registrant's telephone number, including area code: (514) 336-0444

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Shares		MIST		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events

On January 6, 2026, the Company issued a press release announcing the acceptance of a Marketing Authorization Application by the European Medicines Agency seeking the approval of etripamil nasal spray. A decision on approval is expected by the first quarter of 2027. A copy of the press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.  

Exhibit Number		Description of Exhibit
99.1		Press Release dated January 6, 2026
104		Cover Page Interactive Data (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	MILESTONE PHARMACEUTICALS INC.
	By:	/s/Amit Hasija
		Amit Hasija
		Chief Financial Officer
	Dated: January 6, 2026

FAQ

What did Milestone Pharmaceuticals (MIST) announce in this 8-K?

Milestone Pharmaceuticals Inc. announced that the European Medicines Agency has accepted its Marketing Authorization Application seeking approval of etripamil nasal spray.

Which regulatory body accepted Milestone Pharmaceuticals’ etripamil application?

The Marketing Authorization Application for etripamil nasal spray was accepted by the European Medicines Agency.

What product is Milestone Pharmaceuticals seeking EMA approval for?

Milestone Pharmaceuticals is seeking approval for etripamil nasal spray through a Marketing Authorization Application to the European Medicines Agency.

When is a decision on etripamil nasal spray approval expected for Milestone (MIST)?

A decision on approval of etripamil nasal spray is expected by the first quarter of 2027.

What type of SEC filing did Milestone Pharmaceuticals submit for this update?

Milestone Pharmaceuticals submitted a Form 8-K current report to disclose the acceptance of its Marketing Authorization Application by the European Medicines Agency.

On which exchange are Milestone Pharmaceuticals common shares listed and under what symbol?

Milestone Pharmaceuticals’ common shares are listed on The Nasdaq Stock Market LLC under the trading symbol MIST.