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Milestone Pharmaceuticals Receives Approval for Etripamil Nasal Spray in China
Milestone Pharmaceuticals announced that China's National Medical Products Administration has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia in adults. Etripamil, marketed in the United States as CARDAMYST nasal spray, is a self-administered treatment for adults with PSVT. The NMPA decision marks the first regulatory approval of etripamil outside the United States and triggers a $2M milestone payment to Milestone Pharmaceuticals. Everest Medicines has an exclusive license with Milestone to develop etripamil nasal spray in Greater China. Under the License Agreement with Everest, Milestone is also eligible to receive up to $98M in commercial and development milestones and tiered royalties of up to 18% on future sales of etripamil in Greater China. The NMPA approval was based on data from the global pivotal Phase 3 RAPID study and the Phase 3 JX02002 study conducted in China. JX02002 met its primary endpoint, demonstrating that etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes of treatment. Overall, treatment-emergent adverse events were comparable between the etripamil and placebo groups, and no serious adverse events were reported within 24 hours after dosing across Phase 3 studies.
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."
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