(RTTNews) - Milestone Pharmaceuticals Inc. (MIST) is awaiting a pivotal U.S. FDA decision this month on the company's lead drug candidate, CARDAMYST nasal spray, for the acute treatment of paroxysmal supraventricular tachycardia (PSVT).
CARDAMYST (Etripamil) is a novel, fast-acting calcium channel blocker designed to be self-administered by patients outside the hospital setting, offering a potential first-in-class option for rapid conversion of PSVT episodes to normal sinus rhythm.
The FDA has set a PDUFA target action date of December 13, 2025, for its review of the NDA.
The NDA submission was supported by the results from Milestone's Phase 3 NODE clinical program, including long-term safety data from NODE-303 and efficacy data across more than 600 patients. Analyses presented at the American Heart Association Scientific Sessions 2025 showed consistent efficacy and safety across trial designs and geographies, with Etripamil achieving higher conversion rates than placebo. The therapy has also been referenced in recent AHA ACLS Guidelines as a potential intranasal calcium channel blocker option for future treatment algorithms.
Milestone is concurrently advancing Etripamil in atrial fibrillation with rapid ventricular rate (AFib-RVR), but PSVT remains the primary regulatory focus.
The company has finalized the ReVeRA-301 Phase 3 protocol, with plans to pursue a supplemental NDA pathway leveraging PSVT data alongside the AFib program.
Milestone reported $82.6 million in cash as of September 30, 2025, strengthened by a recent equity offering and an amended royalty purchase agreement. The company expects to receive a $75 million milestone payment upon FDA approval from existing shareholder, RTW Investments, LP and certain of its affiliates, supporting a rapid commercial launch.
Approval of CARDAMYST would mark the first new pharmacological option for PSVT in decades and could transition Milestone from a clinical-stage biotech to a commercial entity. With the December decision approaching, investors are closely watching MIST as it faces one of the most critical milestones in its corporate history.
Over the past 12 months, MIST has traded between $0.62 and $2.77. The stock closed yesterday's trading at $2.64, up 0.76%.
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