China's NMPA approved etripamil nasal spray for adult PSVT. Everest owes Milestone $2.0 million.

China's National Medical Products Administration approved etripamil nasal spray for adult PSVT. The decision is Milestone's first etripamil approval outside the United States and triggers a $2.0 million Everest Medicines payment.

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) said on September 3, 2026, that China's National Medical Products Administration (NMPA) has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults. The disclosure is Form 8-K AccNo 0001104659-26-105052, Items 8.01 and 9.01, accepted September 3 at 16:03:58 ET, with the press release attached as Exhibit 99.1.

What China authorized

The NMPA decision covers etripamil nasal spray for adult PSVT. The exhibit calls it the first regulatory approval of etripamil outside the United States. In the United States, the same active product is marketed as CARDAMYST nasal spray. This filing records a China approval. It does not announce a new U.S. Food and Drug Administration action.

PSVT is a type of arrhythmia marked by sudden episodes of rapid heartbeats. The company estimates three to six million people in China and about two million in the United States are currently diagnosed with PSVT. Those are company estimates in the press note, not NMPA findings.

Everest holds Greater China rights — and a $2.0 million check

Everest Medicines has an exclusive license with Milestone to develop etripamil nasal spray in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan. The NMPA approval triggers a $2.0 million milestone payment to Milestone Pharmaceuticals. Under the same license agreement, Milestone says it is also 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. The exhibit does not say whether the $2.0 million sits inside that $98.0 million figure or outside it. Everest is to lead commercialization in Greater China. Launch timing and China pricing are not printed.

The China Phase 3 number in the note

The NMPA approval, as described in Exhibit 99.1, rested on data from the global pivotal Phase 3 RAPID study and the Phase 3 JX02002 study conducted in China. JX02002 met its primary endpoint: etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes of treatment, with a hazard ratio of 3.002 (95% CI: 1.578, 5.711; p = 0.0005). The company says treatment-emergent adverse events were comparable between the etripamil and placebo groups, and that no serious adverse events were reported within 24 hours after dosing across Phase 3 studies.

U.S. status as printed — not a new FDA event

Exhibit 99.1 states that CARDAMYST (etripamil) nasal spray is approved by the U.S. FDA for the conversion of acute symptomatic episodes of PSVT to sinus rhythm in adults. It describes CARDAMYST as a calcium channel blocker nasal spray designed for self-administration. The same exhibit notes Phase 2 work in pediatric PSVT and Phase 3 development for acute atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. Those U.S. statements are background printed in the China-approval note. They are not a separate FDA decision in AccNo 0001104659-26-105052.

Still pending after this note

China commercial launch timing and price. Whether and when the $2.0 million cash is received. How the $2.0 million relates to the up-to-$98.0 million eligibility pot. Royalty tier breakpoints. Any later NMPA labeling detail beyond the adult PSVT indication summarized here.