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. develops and commercializes cardiovascular medicines, centered on CARDAMYST (etripamil) nasal spray. CARDAMYST is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia, or PSVT, to sinus rhythm in adults. Etripamil is also being developed for symptomatic episodic attacks associated with AFib-RVR.
Company news commonly covers CARDAMYST commercialization, payer formulary access, real-world evidence work such as the RESET-PSVT registry, cardiovascular conference presentations, regulatory updates, financial results and business updates. Milestone also reports equity inducement grants and other corporate actions tied to its Nasdaq-listed common shares.
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.
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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