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. (Symbol: MIST) is a biopharmaceutical company headquartered at 6100 Royalmount Ave, Montreal, QC, Canada. The company specializes in developing and commercializing innovative treatments for cardiovascular conditions, with a key focus on its lead investigational product, etripamil.
Milestone's primary product, etripamil, is a calcium channel blocker designed for rapid onset as a nasal spray. This unique formulation allows patients to self-administer the medication to terminate episodes of paroxysmal supraventricular tachycardia (PSVT). PSVT is a condition characterized by an abnormally fast heart rate, which can be both sudden and recurrent.
The company is also conducting a Phase 2 clinical trial to evaluate the efficacy of etripamil for patients with atrial fibrillation experiencing a rapid ventricular rate (AFib-RVR). This trial marks another significant step in expanding the usage of etripamil to address additional cardiovascular indications.
Recent Achievements and Current Projects:
- Milestone intends to use the proceeds from its latest offering to further the development of etripamil for PSVT and AFib-RVR, along with other general corporate purposes.
- The company has secured a shelf registration statement on Form S-3, effective as of February 2, 2022, allowing for streamlined securities offering.
- Milestone actively participates in educational initiatives, such as partnering with the Arrhythmia Alliance for SVT Awareness Day, aimed at raising awareness about heart rhythm disorders.
Financial Condition and Partnerships: Milestone maintains a strong financial position, supported by recent offerings and strategic partnerships. The company's collaborations with healthcare organizations and participation in global awareness campaigns underline its commitment to improving cardiovascular health.
Key Highlights:
- Innovative treatment for PSVT with a patient-administered nasal spray.
- Ongoing Phase 2 trial for AFib-RVR.
- Effective use of proceeds for development and expansion.
- Active involvement in cardiovascular health awareness initiatives.
With a robust pipeline and strategic initiatives, Milestone Pharmaceuticals Inc. is dedicated to addressing unmet needs in cardiovascular care, making significant strides in the biopharmaceutical industry.
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.
Milestone Pharmaceuticals (Nasdaq: MIST) has appointed Joseph Papa to its Board of Directors, effective September 3, 2024. Papa brings over 35 years of experience in the pharmaceutical and healthcare industry, having served as Chairman and CEO of Bausch + Lomb, Bausch Health, and Perrigo. His expertise includes navigating companies through rapid growth, transformation, and strategic M&A transactions.
Robert J. Wills, Chairman of Milestone's Board, expressed enthusiasm for Papa's addition, citing his track record in driving growth and extensive experience across biopharmaceutical companies. Papa's appointment comes as Milestone prepares for the potential approval of CARDAMYST™ (etripamil nasal spray) for paroxysmal supraventricular tachycardia. Papa expressed excitement about joining Milestone, praising the company's leadership, innovation culture, and commitment to improving lives of people with heart conditions.
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