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 granting of equity awards to four new employees on March 4, 2025. The compensation package includes 94,000 stock options with an exercise price of $1.65 per share, matching the company's closing share price on March 3, 2025.
The options were granted under the company's 2021 Inducement Plan and will vest over four years, with 25% vesting after one year and the remaining portion vesting in 36 equal monthly installments. These equity awards were approved by the Company's Compensation Committee and Board of Directors as inducement material for new employment, complying with Nasdaq Listing Rule 5635(c)(4).
Milestone Pharmaceuticals (Nasdaq: MIST) has announced its participation in the TD Cowen 45th Annual Health Care Conference in Boston, scheduled for March 3-5, 2025. President and CEO Joe Oliveto will lead a fireside chat presentation on March 4th at 9:10 AM EST.
The presentation will be accessible through a live webcast for conference attendees, with a replay option available for approximately 90 days afterward on the company's website in the News & Events section at www.milestonepharma.com. Interested parties seeking meetings with the Milestone team during the conference should contact their TD Cowen representative.
Milestone Pharmaceuticals (NASDAQ: MIST) has received a Notice of Allowance from the USPTO for a new Method of Use patent for etripamil nasal spray (CARDAMYST™), their lead product for PSVT management. The patent covers the repeat dose regimen used in the RAPID Phase 3 study and proposed in the CARDAMYST New Drug Application (NDA).
The patent will extend CARDAMYST's intellectual property protection in the US until July 2042, adding 6 years of protection. The repeat dose regimen allows patients to administer a second 70 mg dose if PSVT symptoms persist 10 minutes after the initial dose.
The FDA is currently reviewing CARDAMYST's NDA with a PDUFA target date of March 27, 2025. Milestone is preparing for a potential commercial launch in mid-2025.
Milestone Pharmaceuticals (Nasdaq: MIST) has announced details for its upcoming Commercial Launch Plan investor event, scheduled for February 25, 2025, in New York. The event, running from 10:30 AM to 12:30 PM ET, will be available both in-person and virtually.
The presentation will feature Joseph Oliveto, President and CEO, and Lorenz Muller, Chief Commercial Officer, who will outline the commercial strategy for etripamil nasal spray (proposed trade name CARDAMYST™). This lead investigational product is designed for managing paroxysmal supraventricular tachycardia (PSVT).
The company's New Drug Application (NDA) for CARDAMYST is currently under FDA review, with a PDUFA target date of March 27, 2025. Milestone anticipates a mid-2025 launch for PSVT treatment. The event will conclude with a live Q&A session.
Milestone Pharmaceuticals (MIST) has outlined its strategic priorities for 2025, highlighting the upcoming PDUFA date of March 27, 2025 for CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT). The company is preparing for a mid-2025 commercial launch, pending FDA approval.
The company has strengthened its launch leadership team with Jeff Moore as VP of Sales and plans to deploy approximately 60 sales professionals focusing on cardiologists, electrophysiologists, and cardiac-focused primary care physicians. Sales representatives will be hired around FDA approval time.
Additionally, Milestone plans to initiate a Phase 3 trial for etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) in H1 2025. The study will evaluate a self-administered, repeat-dose regimen of 70 mg/dose, targeting approximately 150 events in patients with symptomatic episodes.
Milestone Pharmaceuticals (Nasdaq: MIST) has announced the granting of equity awards to three new employees. The awards consist of 113,000 stock options to purchase company common shares, issued under the company's 2021 Inducement Plan. The options were granted on January 2, 2025, with an exercise price of $2.17 per share, matching the closing price of Milestone's shares on the grant date.
The options will vest over four years, with 25% vesting after one year and the remaining balance vesting in 36 equal monthly installments. These awards were granted as inducement material for employment in accordance with Nasdaq Listing Rule 5635(c)(4), specifically designed for new hires who were not previously Milestone employees.
Milestone Pharmaceuticals (Nasdaq: MIST) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. President and CEO Joe Oliveto and Chief Commercial Officer Lorenz Muller will engage in a fireside chat on December 4, 2024, at 10:30 a.m. Eastern Time. The event will feature a live webcast available to conference participants. Interested parties can request access to the fireside chat or schedule meetings with the Milestone team by contacting corporateaccess@psc.com.
Milestone Pharmaceuticals (MIST) reported Q3 2024 financial results and provided updates on CARDAMYST™. The FDA is reviewing the NDA for CARDAMYST in PSVT with a PDUFA date of March 27, 2025. The company's partner Corxel reported positive Phase 3 trial results in China, showing 40.5% of patients converting from PSVT to sinus rhythm versus 15.9% for placebo. Financial highlights include cash position of $76.4M as of September 30, 2024. Q3 net loss was $9.4M, reduced from $15.1M in the prior year period. The company plans to initiate a Phase 3 trial for etripamil in AFib-RVR in H1 2025.
Milestone Pharmaceuticals (Nasdaq: MIST) has announced a virtual investor education event scheduled for October 8, 2024, from 10:00 AM to 11:30 AM ET. Titled 'Learnings from the Field: Expert Perspectives on Managing PSVT and Studying AFib-RVR in the Community Setting', the event will feature cardiologists Dr. Aamer H. Jamali and Dr. Farhad Rafii from Interventional Cardiology Medical Group in West Hills, CA.
The presentation will focus on the impact of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation (AFib) on patients, along with current management practices. It will also highlight clinical trial experiences in PSVT and upcoming trials in atrial fibrillation with rapid ventricular rate (AFib-RVR), which could potentially change the standard of care. A live Q&A session will follow the formal presentation.
Milestone Pharmaceuticals (Nasdaq: MIST) announced positive topline results from a Phase 3 study of etripamil nasal spray for paroxysmal supraventricular tachycardia (PSVT) in China, conducted by its licensing partner Ji Xing Pharmaceuticals. The 500-patient trial met its primary endpoint, with 40.5% of etripamil-treated patients converting to sinus rhythm within 30 minutes compared to 15.9% for placebo (p<0.001). Secondary endpoints were also met, and safety data was consistent with previous studies. This expands etripamil's global development to over 2,000 patients. Milestone's partnership with Ji Xing includes potential milestone payments of up to $107.5 million and royalties on future sales in Greater China.
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