Milestone Pharmaceuticals Announces NMPA Approval of Etripamil Nasal Spray for PSVT in China
MIST sits 21% above its 52-week low of $1.
Summary
Milestone Pharmaceuticals announced that China's NMPA approved etripamil nasal spray for PSVT, triggering a $2.0 million milestone payment and unlocking up to $98.0 million in additional milestones plus royalties of up to 18% on Greater China sales.
Key Events · Product Development and Regulatory · MIST
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NMPA Approval of Etripamil for PSVT
China's National Medical Products Administration approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults, marking the first regulatory approval of etripamil outside the United States.
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$2.0M Milestone Payment Triggered
The approval triggers a $2.0 million milestone payment to Milestone Pharmaceuticals under its license agreement with Everest Medicines.
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Up to $98M in Additional Milestones and Royalties
Milestone is eligible to receive up to $98.0 million in commercial and development milestones and tiered royalties of up to 18% on future sales of etripamil in Greater China.
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Clinical Data Supporting Approval
Approval was based on the global Phase 3 RAPID study and the Phase 3 JX02002 study conducted in China, which met its primary endpoint with a hazard ratio of 3.002 (95% CI: 1.578-5.711; p = 0.0005).
Analysis · MIST · Life Sciences
China's NMPA approved etripamil nasal spray for PSVT, marking the first regulatory approval outside the U.S. and triggering a $2.0 million milestone payment to Milestone. The approval also unlocks up to $98.0 million in additional commercial and development milestones plus tiered royalties of up to 18% on future Greater China sales. This expands the commercial opportunity for CARDAMYST into a market with an estimated 3-6 million diagnosed PSVT patients, providing a second revenue stream beyond the U.S. launch.
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At the time of this filing, MIST was trading at $1.21 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $150.6M. The 52-week trading range was $1.00 to $3.06. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.