UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01 Entry into a Material Definitive Agreement.
On July 10, 2025, Milestone Pharmaceuticals Inc. (the “Company”) entered into an amendment (the “Amendment”) to its existing Purchase and Sale Agreement (the “Royalty Purchase Agreement”) with RTW Royalty I DAC, an affiliate of RTW Investments, LP. Pursuant to the Amendment, the Marketing Approval Deadline (as defined in the Royalty Purchase Agreement) has been extended from September 30, 2025 to December 31, 2025.
References to the terms of the Amendment are qualified in their entirety by reference to the full text of the Amendment, which will be filed as an exhibit to the Company’s next applicable periodic report.
Item 8.01 Other Events.
On July 11, 2025, the Company issued a press release announcing that the U.S. Food and Drug Administration has accepted for review the Company’s response to issues raised in the Complete Response Letter regarding its New Drug Application for CARDAMYST (etripamil) nasal spray for the management of paroxysmal supraventricular tachycardia and assigned a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025.
A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated July 11, 2025 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document) |
SIGNATURE
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. | ||
| Dated: July 11, 2025 | By: | /s/Amit Hasija |
| Amit Hasija | ||
| Chief Financial Officer | ||