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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):

May 29, 2024

 

 

 

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 x

 

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. x

 

 

 

 

 

 

Item 8.01. Other Events.

 

On May 29, 2024, Milestone Pharmaceuticals Inc. (“Milestone” or the “Company”) issued a press release announcing that its resubmitted New Drug Application for CARDAMYST (etripamil) nasal spray, its lead investigational product for the management of paroxysmal supraventricular tachycardia, has been accepted for filing by the U.S. Food and Drug Administration and that the Prescription Drug User Fee Act target date is 10 months from the acceptance date of May 26, 2024. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits.

 

Exhibit No. Description
99.1 Press release, dated May 29, 2024.
104 Cover Page Interactive Data File (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.
   
Date: May 29, 2024 By: /s/ Amit Hasija
    Amit Hasija
    Chief Financial Officer Principal Financial Officer