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.
Overview of Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company dedicated to developing and commercializing innovative cardiovascular treatments that empower patients to manage their conditions effectively. Headquartered in Montreal, Canada, Milestone focuses on addressing unmet needs in the cardiovascular space, particularly for patients with episodic and life-altering heart conditions. The company's lead investigational product, etripamil, is a novel calcium channel blocker designed as a rapid-onset nasal spray, offering a self-administered solution for managing symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular rate (AFib-RVR).
Core Business and Product Offering
Milestone's primary value proposition lies in its innovative approach to cardiovascular care. Etripamil is being developed to allow patients to actively participate in managing their heart conditions without requiring immediate medical supervision. This novel treatment approach is particularly significant for conditions like PSVT, characterized by sudden and unpredictable episodes of rapid heart rhythm, and AFib-RVR, which involves irregular and rapid heartbeats. By enabling self-administration, etripamil addresses key challenges in these conditions, such as the unpredictability of episodes and the limitations of existing treatment options, which often require medical intervention or carry significant side effects.
Clinical Development and Market Context
Milestone Pharmaceuticals is advancing etripamil through rigorous clinical trials to establish its safety and efficacy. The company has conducted Phase 2 trials for AFib-RVR and continues to focus on PSVT, where etripamil has shown promise in terminating episodes rapidly. The cardiovascular treatment market is highly competitive, with established pharmaceutical players and emerging biopharma companies vying to address similar conditions. Milestone differentiates itself through its emphasis on patient-centric solutions and self-management, which align with broader healthcare trends toward empowering patients and reducing the burden on healthcare systems.
Challenges and Competitive Positioning
Operating in the biopharmaceutical industry, Milestone faces challenges such as navigating complex regulatory pathways, securing FDA approvals, and demonstrating the clinical and economic value of its treatments. Its reliance on intellectual property, including patents extending to 2042, highlights the importance of innovation and exclusivity in its business model. While competitors may offer alternative treatments for PSVT and AFib-RVR, Milestone's focus on self-administered, rapid-onset therapies positions it uniquely in the market, potentially addressing gaps left by traditional medications and invasive procedures.
Significance and Industry Impact
Milestone's work represents a significant advancement in cardiovascular care, particularly for patients with episodic conditions that can disrupt daily life. The company's innovative approach aligns with the growing demand for treatments that improve patient autonomy and quality of life. By addressing critical unmet needs and leveraging novel delivery mechanisms, Milestone is contributing to the evolution of cardiovascular treatment paradigms, with the potential to set new standards for patient care in its target markets.
Milestone Pharmaceuticals (Nasdaq: MIST) announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference in New York City from September 9-11, 2024. President and CEO Joe Oliveto will engage in a Fireside Chat on September 10th at 2 PM EDT.
The event will be accessible via webcast, available both live and as a replay for approximately 90 days after the presentation. Interested parties can view the webcast in the News & Events section of Milestone's website at www.milestonepharma.com.
This participation provides an opportunity for Milestone Pharmaceuticals to showcase its latest developments and engage with investors in a prominent global investment forum.
Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) announced an upcoming data presentation on etripamil at the ESC Congress 2024 in London on August 30, 2024. Professor John Camm will present patient-reported outcomes data from the NODE-303 Phase 3 trial of etripamil in paroxysmal supraventricular tachycardia (PSVT) in a moderated poster presentation.
The presentation, titled "Quality of Life Measures with Etripamil Self-Administration for Acute Episodes of Paroxysmal Supraventricular Tachycardia in a Medically Unsupervised Setting: Patient-Reported Outcomes from NODE-303," will provide insights about patient experience, satisfaction, and disease management. Dr. David Bharucha, Chief Medical Officer at Milestone Pharmaceuticals, emphasized the importance of this data in understanding the self-administration of investigational etripamil nasal spray in a medically unsupervised setting.
Milestone Pharmaceuticals (Nasdaq: MIST) reported Q2 2024 financial results and provided regulatory updates. Key highlights include:
1. FDA accepted the NDA for CARDAMYST™ (etripamil) nasal spray for PSVT, with a PDUFA date set for March 2025.
2. Cash position of $83.3 million as of June 30, 2024, expected to fund operations into 2026.
3. Planning for Phase 3 trial of etripamil in AFib-RVR, with enrollment expected to start in H1 2025.
4. Q2 2024 net loss of $9.4 million, compared to $16.0 million in Q2 2023.
5. Reduced R&D expenses due to completion of Phase 3 studies.
6. Two new independent directors appointed to the board in July 2024.
Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) has announced its participation in the upcoming BTIG Virtual Biotechnology Conference, scheduled for August 5-6, 2024. The company's President and CEO, Joe Oliveto, will be featured in a Fireside Chat presentation on August 6th at 8 AM EDT.
Investors and interested parties can access the presentation live or as a replay for approximately 90 days after the event. The webcast will be available in the News & Events section of Milestone's corporate website at www.milestonepharma.com. This conference provides an opportunity for Milestone Pharmaceuticals to showcase its latest developments and engage with the investment community in the biotechnology sector.
Milestone Pharmaceuticals (Nasdaq: MIST) has announced a refresh of its Board of Directors. Stuart Duty and Andrew Saik have been appointed as new independent directors, effective immediately. A third independent director will be appointed in the near term. This move comes as part of a Cooperation Agreement with Alta Fundamental Advisers , a shareholder.
Mr. Duty brings over 30 years of experience in investment banking and operations in biotechnology and specialty pharmaceuticals. Mr. Saik has more than 25 years of accounting and finance experience, including CFO roles at several biopharmaceutical companies. The company expects their varied perspectives to provide valuable insights as Milestone approaches an exciting phase.
Debra K. Liebert and Richard C. Pasternak will not seek reelection at the upcoming Annual Meeting. The changes aim to strengthen leadership as Milestone works towards providing new treatment options for patients with paroxysmal supraventricular tachycardia and atrial fibrillation.
Milestone Pharmaceuticals (Nasdaq: MIST) will host Part I of its virtual investor educational series on June 20, 2024, at 8:00 AM ET. The event, titled “Learnings from the Field: Expert Perspectives on Managing PSVT in the Community Setting,” will feature Dr. George Mark and Dr. Vivek Sailam from The Heart House and Cooper University Health Care. They will discuss the impact of paroxysmal supraventricular tachycardia (PSVT) on patients, current treatments, unmet needs, and future treatment expectations. A live Q&A session will follow the presentation.
Milestone Pharmaceuticals (Nasdaq: MIST) announced its participation in the Jefferies Global Healthcare Conference in New York City from June 4-6, 2024. The company's management will engage in a Fireside Chat on June 6 at 11:30 AM EDT. The event will be webcast live and available for replay for about 90 days on Milestone's website.
Milestone Pharmaceuticals announced the FDA's acceptance of its New Drug Application for CARDAMYST, an etripamil nasal spray intended for managing paroxysmal supraventricular tachycardia (PSVT). This milestone occurred on May 26, 2024, with a Prescription Drug User Fee Act (PDUFA) target date set for ten months later. The clinical trial program for CARDAMYST is the largest data package studied for an acute drug treatment for PSVT self-management. Milestone is preparing for the anticipated launch of the product under the trade name CARDAMYST, which has conditional FDA approval.
Milestone Pharmaceuticals (Nasdaq: MIST) is partnering with Arrhythmia Alliance to raise awareness about supraventricular tachycardia (SVT). SVT Awareness Day is scheduled for June 5, 2024, during World Heart Rhythm Week (June 4-10). SVT affects two million people in the U.S., causing rapid heartbeats, breathlessness, and anxiety. The awareness campaign includes virtual coffee mornings, Live X Chat, and Facebook Live sessions with healthcare experts. Educational videos from patients and healthcare providers will also be released. The aim is to improve understanding and treatment of SVT, which often requires costly and invasive medical procedures.
Milestone Pharmaceuticals Inc. reported financial results for Q1 2024, resubmitted NDA for etripamil in PSVT, with expected FDA approval in the first half of 2025. The company's cash position is sufficient until 2026, with potential synthetic royalty payment. New clinical data for etripamil's real-world use were presented. Phase 3 guidance for etripamil in AFib-RVR was received from the FDA. Milestone closed a public offering, raising $32.2 million for development and commercialization. Financially, the company had $89.5 million in cash and no revenue in Q1 2024.
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