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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 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.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced upcoming data presentations on etripamil at ISPOR 2024, the 2024 Stanford BioDesign Arrhythmia Technologies Retreat, and Heart Rhythm 2024. The presentations will cover topics such as healthcare resource utilization in clinical trials and the effectiveness of etripamil nasal spray in termination of cardiac conditions.
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