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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 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.
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.
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