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Milestone Pharmaceuticals Launches Phase 3 Trial for Etripamil
Milestone Pharmaceuticals announced that the first patient has been enrolled in the Phase 3 ReVeRA-301 pivotal trial evaluating etripamil for atrial fibrillation with rapid ventricular rate. The trial uses the same repeat-dose regimen as the pivotal trials for etripamil, which is FDA-approved for paroxysmal supraventricular tachycardia as Cardamyst nasal spray.
Milestone Pharmaceuticals Q2 Revenue at $559,000
Reports Q2 revenue $559,000, consensus $816,670. "We continue to make steady progress on the launch of CARDAMYST for PSVT supported by prescription growth from a widening base of new prescribers and a meaningful recent increase in insurance coverage. We are confident that this increased coverage paired with optimized sales and marketing strategies positions us to drive acceleration of CARDAMYST prescriptions moving forward," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Separately, we have activated several sites in our Phase 3 ReVeRA-301 trial in AFib-RVR and look forward to enrolling the first patient. AFib-RVR is one of the most common heart arrhythmias, affecting millions of Americans. The trial is evaluating the same self-administered regimen already approved in PSVT, giving us a clear path toward extending etripamil to a larger, adjacent patient population."
Milestone Pharmaceuticals Files $300M Mixed Securities Shelf
Milestone Pharmaceuticals files $300M mixed securities shelf
Milestone Pharmaceuticals Q1 Revenue $238,000
Reports Q1 revenue $238,000, consensus $37.64M. "We're excited to report on our first quarter of sales for CARDAMYST for paroxysmal supraventricular tachycardia, or PSVT. Healthcare professionals' initial reaction to the product is positive and we are very encouraged by the early breadth of unique prescribers writing for their patients," said Joseph Oliveto, President and CEO of Milestone Pharmaceuticals. "Gaining Express Scripts' national formulary coverage in March reflects meaningful early payor adoption, highlighting the value CARDAMYST offers to insurers. We are also observing clinician enthusiasm for expanded development of etripamil in patients with AFib-RVR, as we have now kicked off our Phase 3 pivotal trial and are actively engaging potential clinical trial sites."
Milestone Pharmaceuticals Announces Cardamyst Study Plan
Milestone Pharmaceuticals announced details on RESET-PSVT, a planned Phase 4, multicenter, prospective, observational registry intended to generate real-world evidence on the use of Cardamyst nasal spray in adults with paroxysmal supraventricular tachycardia. "Registry of Etripamil Studies Evaluating Treatment in Paroxysmal Supraventricular Tachycardia: Study Design," was presented in a poster session at the Preventive Cardiovascular Nurses Association Cardiovascular Nursing Symposium in Scottsdale, Arizona. The study will be led by the Duke Clinical Research Institute. RESET-PSVT is expected to enroll an estimated 450 adult patients across approximately 20 electrophysiology and cardiology sites, with enrollment beginning by the end of 2026. The registry is designed to evaluate patients who have been prescribed Cardamyst as well as patients prescribed or given other therapies, with enrolled patients and their healthcare providers completing patient- and provider-outcome surveys, respectively. The study's primary endpoint is to characterize patterns of use of Cardamyst in PSVT management, including frequency of PSVT episodes, frequency of use of Cardamyst, number of doses administered per episode and triggers for use. Secondary endpoints include comparisons between Cardamyst and non-Cardamyst users across patient-reported quality of life, healthcare utilization and episode characteristics. Exploratory analyses are expected to evaluate prescribing and use patterns across patient subgroups, along with qualitative analysis of participant experience.
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