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. (MIST) is a clinical-stage biopharmaceutical company pioneering patient-administered therapies for cardiovascular emergencies. This page serves as the definitive source for verified news and press releases related to MIST's innovative arrhythmia treatments, including etripamil nasal spray for PSVT and AFib-RVR management.
Investors and medical professionals will find timely updates on clinical trial progress, regulatory milestones, and strategic partnerships. Our curated news collection provides essential insights into the company's scientific advancements while maintaining compliance with financial disclosure standards.
Key content categories include FDA submission updates, phase 3 trial results analysis, intellectual property developments, and executive leadership announcements. All materials are vetted for accuracy and relevance to support informed decision-making.
Bookmark this page for streamlined access to MIST's latest developments in rapid-onset cardiovascular therapies. Check regularly for updates on groundbreaking treatment models that combine medical innovation with patient empowerment.
Milestone Pharmaceuticals (NASDAQ: MIST) received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for CARDAMYST™ (etripamil) nasal spray, a treatment for converting acute PSVT episodes to sinus rhythm in adults.
The CRL focused on two Chemistry, Manufacturing and Controls (CMC) issues: additional information needed on nitrosamine impurities based on new draft guidance, and a required inspection at a facility performing release testing that changed ownership during NDA review. Notably, the FDA raised no concerns about etripamil's clinical safety or efficacy data.
The company plans to request a Type A meeting to discuss addressing these issues in a resubmission. As of December 31, 2024, Milestone reported $69.7 million in cash, cash equivalents and short-term investments.
Milestone Pharmaceuticals (Nasdaq: MIST) announced it will present a moderated poster at the American College of Cardiology annual meeting (ACC25) in Chicago from March 29-31, 2025. The presentation will focus on clinical data for etripamil, showcasing its potential to convert multiple episodes of Paroxysmal Supraventricular Tachycardia (PSVT) to normal sinus rhythm.
According to Chief Medical Officer Dr. David Bharucha, the data demonstrates that successful conversion of earlier PSVT episodes predicts success in subsequent treatments. The findings support etripamil's potential use for successive PSVT episodes, pending approval, aiming to improve patient experience and quality of life.
Milestone Pharmaceuticals (NASDAQ: MIST) has reported its Q4 and full year 2024 financial results, highlighting the upcoming FDA PDUFA review date of March 27, 2025, for CARDAMYST™ nasal spray for PSVT treatment. The company plans a mid-2025 launch, pending approval.
Financial highlights include:
- Cash position of $69.7 million as of December 31, 2024
- Q4 2024 net loss of $12.4 million ($0.19 per share)
- Full-year 2024 net loss of $41.5 million ($0.67 per share)
Notable developments include a new Method of Use patent potentially extending CARDAMYST protection until 2042, and plans to initiate a Phase 3 trial for etripamil in AFib-RVR in 2025. The company's R&D expenses decreased to $14.4 million in 2024 from $31.1 million in 2023, while G&A expenses increased slightly to $16.7 million from $15.9 million.
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.
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