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) reported FDA approval and U.S. launch of CARDAMYST (etripamil) nasal spray for acute symptomatic PSVT, with retail availability in late January 2026 and national sales deployment in mid-February 2026. The company reported $106.0 million cash at year-end and pro forma liquidity of about $200 million supporting runway into late 2027.
Full-year 2025 results include $1.5 million revenue, R&D $18.1 million, commercial expense $28.3 million, and a net loss of $63.1 million. EMA MAA accepted with a decision expected by H1 2027.
Milestone (Nasdaq: MIST) will present data at ACC.26 (March 28-30, 2026) showing minimal blood pressure effects after intranasal etripamil (CARDAMYST) test dosing.
Phase 3 analysis reported mean systolic BP change ~1.8 mmHg (single 70 mg, N=440) and TEAE rates of hypotension 0.4% and syncope 0.2% (N=1,610), supporting potential safe self-administration for adults with PSVT.
Milestone Pharmaceuticals (Nasdaq: MIST) will report its fourth quarter and full-year 2025 results and provide a business update on Friday, March 20, 2026 before the market opens. A conference call and webcast for investors is scheduled at 8:30am ET.
Access details include domestic and international dial‑in numbers, a conference ID, a Call me™ option active 15 minutes before start, and a replay available on the company’s Investors and Media website.
Milestone Pharmaceuticals (Nasdaq: MIST) will present at the TD Cowen 46th Annual Health Care Conference in Boston, March 2-4, 2026. Amit Hasija, CFO, and Lorenz Muller, Chief Commercial Officer, will speak.
A live webcast is scheduled for March 3, 2026 at 9:10 AM EST, with a replay available for approximately 90 days on the company website. Meetings can be requested through TD Cowen representatives.
Milestone Pharmaceuticals (Nasdaq: MIST) appointed David Sandoval as General Counsel and Chief Compliance Officer effective Feb 10, 2026, coinciding with the commercial launch of CARDAMYST™ (etripamil) nasal spray. CARDAMYST received FDA approval on December 12, 2025 as a self-administered treatment for acute PSVT conversion in adults.
Sandoval brings more than 15 years of legal and compliance experience across life sciences, SEC compliance, commercialization, and major strategic transactions, and will advise across contracts, finance, IR, BD, IP and HR.
Milestone Pharmaceuticals (Nasdaq: MIST) granted a total of 419,000 stock options as inducement awards to two new employees under its 2021 Inducement Plan.
The options were granted on February 2, 2026 with an exercise price of $1.96 per share (equal to the closing price). The awards vest over four years: 25% at the one-year anniversary, then monthly over 36 months, and are subject to continuous service and Plan terms. The grants were made pursuant to Nasdaq Listing Rule 5635(c)(4) and the Plan is reserved for inducement hires or rehires following non-employment.
Milestone Pharmaceuticals (Nasdaq: MIST) announced U.S. commercial availability of CARDAMYST (etripamil) nasal spray, a prescription, self‑administered treatment indicated to convert acute symptomatic paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
The FDA approved CARDAMYST on December 12, 2025. The product is now available through U.S. retail pharmacies, with a national sales force planned for deployment in mid‑February 2026. Launch support includes a patient assistance platform offering benefits verification, reimbursement support, and copay assistance; eligible commercially insured patients are expected to have a $25 copay cap.
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.