Every 8-K that Milestone Pharmaceuticals (MIST) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow MIST and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full MIST filings page.
Milestone Pharmaceuticals Inc. (MIST) announced that China’s National Medical Products Administration has approved etripamil nasal spray for treatment of paroxysmal supraventricular tachycardia (PSVT) in adults, the first regulatory approval for etripamil outside the United States.
The approval triggers a $2.0 million payment to Milestone from partner Everest Medicines, which holds exclusive development and commercialization rights in Greater China. Milestone is also eligible for up to $98.0 million in additional commercial and development milestones and tiered royalties of up to 18% on future sales in Greater China. The decision was supported by Phase 3 data, including the JX02002 study in China, where etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes.
Milestone Pharmaceuticals Inc. reported second-quarter 2026 results and business updates centered on the launch of CARDAMYST, its FDA-approved nasal spray for paroxysmal supraventricular tachycardia (PSVT). Product revenue was $559,000 for the quarter and $797,000 for the first six months of 2026, compared with no product revenue a year earlier.
Cash, cash equivalents and short-term investments totaled $170.6 million as of June 30, 2026, up from $106.0 million as of December 31, 2025, and the company expects this to fund operations into the second half of 2027. The quarterly net loss widened to $28.6 million, or $0.21 per share, from $13.0 million, or $0.20 per share, driven largely by a jump in selling, general and administrative expense to $22.6 million as the company supports the CARDAMYST launch.
Commercially, Milestone states that over half of commercially insured lives in the U.S. now have coverage for CARDAMYST. Internationally, European review of etripamil for PSVT is ongoing with a targeted decision in the first half of 2027, and a New Drug Application in China is under review. The Phase 3 ReVeRA-301 registrational trial of etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR) is open, with several sites activated and patients being evaluated for enrollment.
Milestone Pharmaceuticals Inc. reported results from its 2026 annual shareholder meeting. Shareholders approved an amendment to the 2019 Equity Incentive Plan that increases the number of ordinary shares authorized for issuance by 6,800,000 shares, expanding the pool available for future equity-based compensation.
All eight director nominees were elected, each receiving roughly 23.4–24.2 million votes for and about 3.1–3.9 million votes withheld, with 48.6 million broker non-votes recorded per nominee. Shareholders also ratified PricewaterhouseCoopers LLP as auditor with 75,025,285 votes for, 249,836 against and 664,912 abstentions.
They approved the amended 2019 Equity Incentive Plan with 19,262,773 votes for, 5,479,043 against, 2,617,059 abstentions and 48,581,158 broker non-votes. In a non-binding advisory vote on executive pay, 19,665,705 votes supported the compensation of named executive officers, 6,990,920 were against, 702,247 abstained and 48,581,161 were broker non-votes.
Milestone Pharmaceuticals reported first quarter 2026 results and its first commercial sales of CARDAMYST for paroxysmal supraventricular tachycardia. Product revenue, net was $238 thousand, reflecting the early launch, while the company recorded a net loss of $26,066 thousand, or $0.20 per share, compared with a net loss of $20,761 thousand a year earlier.
Commercial expenses rose as the company invested $15,812 thousand in launch activities, up from $10,378 thousand in 2025. As of March 31, 2026, Milestone held cash and cash equivalents of $71,317 thousand and short-term investments of $112,899 thousand. Management highlighted positive early prescriber adoption, Express Scripts national formulary coverage for CARDAMYST, and initiation of a Phase 3 pivotal trial of etripamil in atrial fibrillation with rapid ventricular rate.
Milestone Pharmaceuticals reported a larger net loss in 2025 as it transitioned into commercial stage following FDA approval of CARDAMYST nasal spray for paroxysmal supraventricular tachycardia (PSVT) and its U.S. launch. Revenue reached $1,546 thousand in 2025, up from none in 2024, reflecting initial product and license activity.
Operating expenses rose as the company invested in research, administration and a full commercial build-out, leading to a net loss of $63,058 thousand versus $41,519 thousand in 2024, or a basic and diluted net loss per share of $0.75 compared with $0.67. Year-end 2025 cash and cash equivalents were $73,046 thousand, with total assets of $113,561 thousand and shareholders’ equity of $41,769 thousand.
Milestone Pharmaceuticals Inc. filed a current report describing that it has issued a press release announcing the availability of CARDAMYST (etripamil) nasal spray in the United States. The product is indicated for the management of paroxysmal supraventricular tachycardia, a type of rapid heart rhythm. The press release with additional details is included as Exhibit 99.1 and is incorporated by reference into the report.
Milestone Pharmaceuticals Inc. reported that it has closed a previously arranged royalty financing tied to its drug candidate etripamil. Under a Royalty Purchase Agreement originally signed in March 2023, funds managed by RTW Investments agreed to pay a purchase price of $75.0 million after U.S. Food and Drug Administration approval of etripamil, in exchange for a right to receive tiered quarterly royalties on annual net product sales of etripamil in the United States.
On January 12, 2026, the company completed this transaction and received the $75.0 million payment from certain funds managed by RTW in return for the royalty interest. Going forward, those RTW-managed funds are entitled to the specified tiered royalty stream on U.S. sales of etripamil, while Milestone retains the upfront cash proceeds from the sale.
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.
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.
Milestone Pharmaceuticals Inc. filed a report stating that on November 12, 2025 it issued a press release covering its financial results for the third quarter ended September 30, 2025.
The press release also includes a regulatory and corporate update, giving readers insight into recent business and regulatory developments alongside the quarterly numbers. This press release is furnished as Exhibit 99.1 to the report and incorporated by reference, meaning the detailed figures and commentary are contained in that attached document.
Milestone Pharmaceuticals reported that it issued a press release announcing its financial results for the quarter ended June 30, 2025 and providing a regulatory and corporate update. The Form 8-K states the press release is attached as Exhibit 99.1 and is incorporated by reference; the filing text itself does not include the numerical results or detailed financial tables. The 8-K also lists the Interactive XBRL cover page file as Exhibit 104 and identifies the disclosure under the Results of Operations and Financial Condition item. Investors are directed to the attached press release for substantive figures and commentary.
Milestone Pharmaceuticals Inc. (NASDAQ: MIST) filed an 8-K on 10 July 2025 disclosing two material events:
- Royalty Purchase Agreement Amendment (Item 1.01): The Company and RTW Royalty I DAC agreed to extend the Marketing Approval Deadline for etripamil from 30 Sep 2025 to 31 Dec 2025. The amendment provides Milestone with an additional three months to secure U.S. marketing approval before contractual milestone or repayment provisions are triggered. Full terms will be included in the next periodic filing.
- Regulatory Update (Item 8.01): On 11 July 2025 the FDA accepted Milestone’s complete response to the prior Complete Response Letter for its New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray targeting paroxysmal supraventricular tachycardia. The agency set a new Prescription Drug User Fee Act (PDUFA) action date of 13 Dec 2025.
Investment view: FDA acceptance and a defined PDUFA date re-start the approval clock, reducing regulatory uncertainty and acting as an upside catalyst. The three-month extension in the royalty agreement aligns contractual timelines with the new PDUFA date, avoiding potential covenant breaches. No financial statements were included, but successful approval would unlock royalty financing and potential commercialization revenue.