Milestone Pharma wins FDA OK for CARDAMYST PSVT nasal spray

Milestone Pharmaceuticals Inc. reports that the U.S. Food and Drug Administration has approved its New Drug Application for CARDAMYST (etripamil) nasal spray for the management of paroxysmal supraventricular tachycardia (PSVT).

Rhea-AI Filing Summary

Milestone Pharmaceuticals Inc. reports that the U.S. Food and Drug Administration has approved its New Drug Application for CARDAMYST (etripamil) nasal spray for the management of paroxysmal supraventricular tachycardia (PSVT).

The company also furnished a new corporate presentation dated December 15, 2025, which is available as an exhibit and through the Investors & Media section of its website. Milestone states that it intends to use this website section to provide material information in line with Regulation FD, alongside press releases, SEC filings, and public calls or webcasts.

Positive

• U.S. FDA approval of Milestone’s New Drug Application for CARDAMYST (etripamil) nasal spray for the management of paroxysmal supraventricular tachycardia (PSVT).

Negative

• None.

Insights

Biotech regulatory analyst

FDA approval of CARDAMYST marks a major regulatory milestone for Milestone Pharmaceuticals and its PSVT treatment focus.

The company discloses that the U.S. Food and Drug Administration has approved its New Drug Application for CARDAMYST (etripamil) nasal spray for the management of paroxysmal supraventricular tachycardia (PSVT). Approval of a New Drug Application is a central step in bringing a prescription therapy to patients, so this represents a significant advancement for Milestone’s lead program.

Milestone also notes that it has prepared a corporate presentation dated December 15, 2025, filed as Exhibit 99.1 and accessible via the Investors & Media section of its website. The company states that it intends to use this website section, together with press releases, SEC disclosures, and public calls or webcasts, to provide material information consistent with Regulation FD.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

What major regulatory milestone did Milestone Pharmaceuticals (MIST) disclose?

Milestone Pharmaceuticals reported that the U.S. Food and Drug Administration has approved its New Drug Application for CARDAMYST (etripamil) nasal spray for the management of PSVT.

What is CARDAMYST (etripamil) nasal spray approved to manage for Milestone Pharmaceuticals (MIST)?

CARDAMYST (etripamil) nasal spray is approved by the U.S. Food and Drug Administration for the management of paroxysmal supraventricular tachycardia (PSVT).

When did the FDA approve Milestone Pharmaceuticals' CARDAMYST nasal spray?

Milestone states that on December 12, 2025, the U.S. Food and Drug Administration approved its New Drug Application for CARDAMYST (etripamil) nasal spray for PSVT.

What investor materials did Milestone Pharmaceuticals (MIST) provide on December 15, 2025?

On December 15, 2025, Milestone Pharmaceuticals provided a corporate presentation that may be used in conferences and investor meetings, filed as Exhibit 99.1 and accessible via its Investors & Media website section.

How does Milestone Pharmaceuticals plan to use its website for Regulation FD disclosure?

Milestone states that it intends to use the Investors & Media section of its website to disclose material non-public information and comply with Regulation FD, in addition to press releases, SEC filings, and public conference calls and webcasts.

Which exhibits accompany this Milestone Pharmaceuticals (MIST) SEC disclosure?

The disclosure lists Exhibit 99.1 as a corporate presentation dated December 15, 2025, Exhibit 99.2 as a press release dated December 12, 2025, and Exhibit 104 as cover page interactive data.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 12/15/2025 - 08:56 AM Learn about SEC filing dates

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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):

December 12, 2025

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 7.01. Regulation FD Disclosure.

On December 15, 2025, Milestone Pharmaceuticals Inc. (“Milestone” or the “Company”) provided a corporate presentation that may be used in connection with presentations at conferences and investor meetings. The full text of the Company’s corporate presentation is filed as Exhibit 99.1 hereto, and incorporated herein by reference, and may also be accessed through the “Investors & Media” section of the Company’s website at www.milestonepharma.com.

The Company intends to use its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on its website in the “Investors & Media” section. Accordingly, investors should monitor such portions of its website, in addition to following press releases, filings with the U.S. Securities Exchange Commission (the “SEC”) and public conference calls and webcasts.

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, or the Securities Act. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing with the SEC, made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 8.01 Other Events

On December 12, 2025, the Company issued a press release announcing that the U.S. Food and Drug Administration has approved the Company’s New Drug Application for CARDAMYST (etripamil) nasal spray for the management of paroxysmal supraventricular tachycardia (PSVT). A copy of the press release is filed herewith as Exhibit 99.2 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	Corporate Presentation, dated December 15, 2025
99.2	Press Release dated December 12, 2025
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: December 15, 2025