Welcome to our dedicated page for Milestone Pharmaceuticals news (Ticker: MIST), a resource for investors and traders seeking the latest updates and insights on Milestone Pharmaceuticals stock.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) generates news primarily around its cardiovascular drug programs, regulatory milestones, and corporate developments. The company’s lead product, CARDAMYST™ (etripamil) nasal spray, is FDA approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults, and many of its announcements relate to this therapy and the broader etripamil clinical program.
News items for MIST often cover regulatory events, such as U.S. Food and Drug Administration actions on CARDAMYST, responses to Complete Response Letters, Prescription Drug User Fee Act (PDUFA) dates, and acceptance of a Marketing Authorization Application by the European Medicines Agency for etripamil nasal spray with the conditionally approved brand name TACHYMIST™ in Europe. These updates provide context on how the company’s PSVT program is progressing in major regulatory jurisdictions.
Another frequent category is clinical and scientific data. Milestone issues press releases on new analyses from its etripamil trials in PSVT and AFib-RVR, including pooled efficacy and safety results presented at medical meetings such as the American Heart Association Scientific Sessions. These articles describe conversion rates to sinus rhythm, time to conversion, and safety findings across randomized and open-label studies.
Investors and followers of MIST will also see corporate and financial news, including quarterly financial results, equity offerings, royalty purchase agreements, and inducement option grants under Nasdaq Listing Rule 5635(c)(4). Such releases outline how the company funds development and commercialization activities and how it prepares for the launch and distribution of CARDAMYST.
This news page aggregates these types of updates so readers can track Milestone’s regulatory progress, clinical data disclosures, and financing events in one place. Users interested in MIST can review past and recent headlines to understand how the company’s cardiovascular portfolio and commercial plans are evolving over time.
Milestone Pharmaceuticals (Nasdaq: MIST) announced the EMA accepted its Marketing Authorization Application (MAA) for etripamil nasal spray (brand name TACHYMIST) for treatment of paroxysmal supraventricular tachycardia (PSVT).
A regulatory decision is expected by Q1 2027. If approved, etripamil is intended as a rapid, patient self‑administered nasal spray for PSVT outside healthcare settings and the MAA uses the global clinical data that supported prior U.S. FDA approval.
The company highlighted a potential patient population of about 2 million people in Europe who suffer from PSVT.
Aptar (NYSE: ATR) announced its Bidose (BDS) Liquid Nasal Spray System is the delivery mechanism for CARDAMYST (etripamil) nasal spray, which received FDA approval for conversion of acute symptomatic PSVT to sinus rhythm in adults on December 17, 2025.
The product pairs two Bidose devices in a protective dual-container with an integrated cap designed to prevent accidental activation and aid portability. Aptar provided device development and regulatory support via its Pharma Services offerings in collaboration with Milestone Pharmaceuticals.
Milestone (Nasdaq: MIST) announced FDA approval of CARDAMYST (etripamil) nasal spray for conversion of acute symptomatic paroxysmal supraventricular tachycardia (PSVT) in adults, the first FDA‑approved PSVT treatment in 30+ years for more than 2 million Americans. CARDAMYST is expected to be available in retail pharmacies in Q1 2026. Approval is supported by safety data from >1,800 participants and >2,000 PSVT episodes, including the Phase 3 RAPID trial (64% vs 31% conversion at 30 minutes; HR=2.62; p<0.001) and a median time to conversion of 17 vs 54 minutes. Milestone said it is well‑capitalized to launch using existing capital and royalty financing and is pursuing a Phase 3 program for AFib‑RVR via an sNDA pathway.
Milestone Pharmaceuticals (Nasdaq: MIST) granted a total of 30,000 stock options as inducement awards to two newly hired employees under its 2021 Inducement Plan, with a grant date of December 1, 2025.
The options have an exercise price of $2.69 per share (equal to the closing price on the grant date) and vest over four years: 25% at the one-year anniversary and the remainder in 36 equal monthly installments. Awards are subject to continuous service and standard plan terms and were made in accordance with Nasdaq Listing Rule 5635(c)(4).
Milestone Pharmaceuticals (NASDAQ: MIST) reported Q3 2025 results and regulatory updates ahead of a PDUFA target date of December 13, 2025 for CARDAMYST (etripamil) nasal spray in PSVT. The company had $82.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025, and completed an underwritten equity offering with ~$48.7 million net proceeds plus an amended royalty purchase agreement that includes a $75 million royalty payment upon FDA approval. Clinical data from >600 patients showed consistent efficacy and safety versus placebo. Milestone is preparing for a rapid commercial launch and finalized a Phase 3 protocol in AFib-RVR (ReVeRA-301).
Milestone Pharmaceuticals (Nasdaq: MIST) granted 65,000 stock options as a material inducement under its 2021 Inducement Plan on a Nov 3, 2025 grant date.
The options have an exercise price of $1.85 per share (equal to the closing price on the grant date) and vest over four years: 25% on the one‑year anniversary of the vesting commencement date, then the remainder in 36 equal monthly installments. Awards are subject to continuous service and the Plan's grant agreements. The grant was made in accordance with Nasdaq Listing Rule 5635(c)(4) and the Plan is designated for inducement awards to new hires or those returning after bona fide non‑employment.
Milestone (Nasdaq: MIST) announced pooled analyses showing consistent efficacy, tolerability, and safety for investigational etripamil nasal spray in self‑administered treatment of PSVT.
Key pooled results: 622 enrolled patients across trials; median time to conversion 18.5 minutes (95% CI: 15.7–21.0); Kaplan‑Meier conversion by 30 minutes 59.6% (range 53.6%–64.3%); conversion by 60 minutes 63.2%–75.1%. Safety from >1,050 treated patients was described as predominantly mild, transient, and nasal‑site localized; test‑dose failure rate was 1.4% among >1,100 dosed in sinus rhythm.
Data will be presented Nov 10, 2025 at AHA Scientific Sessions by James Ip, M.D. The FDA PDUFA date for the CARDAMYST NDA is Dec 13, 2025.
Milestone Pharmaceuticals (Nasdaq: MIST) will present a poster at the American Heart Association Scientific Sessions 2025 in New Orleans on November 10, 2025. The poster reports combined data on the efficacy, safety, and test-dose tolerability of self-administered etripamil for acute paroxysmal supraventricular tachycardia (PSVT) across multiple clinical trials.
The presentation is by James Ip, M.D. and is scheduled for Monday, November 10, 2025, 10:30–11:30 AM CST. The data describe patient-administered use of etripamil focusing on acute PSVT episodes.
Milestone Pharmaceuticals (NASDAQ: MIST) announced its participation in two upcoming healthcare conferences. CEO Joe Oliveto will conduct one-on-one meetings at the Wells Fargo Healthcare Conference in Boston (September 3-5, 2025) and deliver a corporate presentation at the H.C. Wainwright 27th Annual Global Investment Conference in New York (September 8-10, 2025).
The H.C. Wainwright presentation will be webcast live on September 9 at 12:00 PM EDT, with a replay available for approximately 90 days on the company's website.
Milestone Pharmaceuticals (Nasdaq: MIST) reported Q2 2025 financial results and significant regulatory progress for CARDAMYST™. The FDA accepted the company's Complete Response Letter (CRL) response, setting a new PDUFA date of December 13, 2025 for their PSVT treatment.
The company substantially strengthened its financial position through a public offering raising up to $170 million in gross proceeds if all warrants are exercised, with immediate net proceeds of $48.7 million. Additionally, Milestone extended its $75 million royalty agreement with RTW Investments through December 2025.
Q2 2025 financial results showed a net loss of $13.0 million, compared to $9.4 million in Q2 2024. The company ended the quarter with $43.4 million in cash and equivalents, while commercial expenses increased to $5.1 million as they prepare for CARDAMYST's potential launch.
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