Milestone earns China approval triggering $2 million payment
- Milestone Pharmaceuticals (NASDAQ:MIST) received regulatory approval from China's National Medical Products Administration for its etripamil nasal spray.
- The company earned an immediate $2 million payment and unlocked eligibility for up to $98 million in future commercial milestones.
- The company stated the approval allows its licensing partner Everest Medicines to advance commercialization of the paroxysmal supraventricular tachycardia treatment across Greater China.
Milestone Pharmaceuticals (NASDAQ:MIST) received regulatory approval from China's National Medical Products Administration for its etripamil nasal spray, triggering a $2 million milestone payment.
This regulatory decision marks the first authorization for the paroxysmal supraventricular tachycardia treatment in a market outside the United States.
Phase 3 clinical trial results demonstrated the drug was significantly superior to placebo in converting patients to a normal sinus rhythm within 30 minutes.
The company stated that its commercial partnership with Everest Medicines unlocks eligibility for up to $98 million in future development milestones and tiered royalties up to 18% on regional sales.
Researchers recorded a hazard ratio of 3.002 during the late-stage efficacy evaluations compared to standard placebo treatments.
The company noted the drug's safety profile maintained comparable adverse events to placebo, with no serious adverse events occurring within 24 hours of administration across Phase 3 trials.
