Milestone Pharmaceuticals Announces NMPA Approval of Etripamil Nasal Spray for PSVT in China, Marking First Regulatory Approval of Etripamil Outside of the United States
China’s NMPA approval of etripamil for PSVT unlocks immediate and potential future payments and royalties for Milestone via its Everest partnership.
Rhea-AI Summary
Milestone Pharmaceuticals (MIST) received approval from China’s National Medical Products Administration (NMPA) for etripamil nasal spray to treat paroxysmal supraventricular tachycardia (PSVT) in adults in China, marking the first regulatory approval of etripamil outside the United States.
The decision triggers a $2.0 million milestone payment to Milestone. Everest Medicines holds exclusive rights to develop and commercialize etripamil in Greater China and, under the license, Milestone is eligible for up to $98.0 million in additional commercial and development milestones plus tiered royalties of up to 18% on future sales. Approval is supported by the global Phase 3 RAPID study and China Phase 3 JX02002 trial, where etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes (hazard ratio 3.002; p=0.0005), with comparable adverse events to placebo and no serious adverse events within 24 hours of dosing across Phase 3 studies.
Positive
- $2.0 million milestone payment triggered by NMPA approval in China
- Eligibility for up to $98.0 million in additional commercial and development milestones
- Tiered royalties of up to 18% on future etripamil sales in Greater China
- First approval outside the U.S. expands etripamil’s regulatory footprint to the China market
- Phase 3 JX02002 met primary endpoint with hazard ratio 3.002 and p=0.0005
- No serious adverse events reported within 24 hours after dosing across Phase 3 studies
Negative
- None.
Market reaction after China NMPA approval: MIST +4.16%
Following this news, MIST has gained 4.16%, reflecting a moderate positive market reaction. Our momentum scanner has triggered 5 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $1.23. Trading volume is very high at 4.1x the average, suggesting strong buying interest.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Sep 02 | Investor conferences | Neutral | +3.5% | Upcoming healthcare conference presentations and one-on-one investor meetings |
| Aug 27 | PSVT quality-of-life data | Neutral | +0.8% | Survey highlighted lifestyle disruption, anxiety, and unmet treatment needs |
| Aug 21 | Phase 3 trial initiation | Positive | +2.4% | First patient enrolled in pivotal AFib-RVR ReVeRA-301 trial |
| Aug 12 | Second-quarter earnings | Negative | -11.4% | Widening net loss accompanied commercial launch and liquidity update |
| Aug 04 | Earnings date announcement | Neutral | -2.1% | Company scheduled second-quarter results and investor conference call |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
MIST's recent news reactions were mixed, with clinical-trial news followed by a 2.43% gain but earnings news followed by an -11.42% decline.
Key Terms
nmpa regulatory
paroxysmal supraventricular tachycardia medical
hazard ratio technical
calcium channel blocker medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Everest Medicines to Lead Commercialization in Greater China, Bringing Novel Innovation to Estimated 3-6 Million Chinese Patients with PSVT
Approval Triggers
MONTREAL and CHARLOTTE, N.C., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that China’s National Medical Products Administration (NMPA) has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) 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
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 (hazard ratio = 3.002 [
“We believe the approval of etripamil nasal spray in China represents exciting progress toward our vision to help patients around the world living with PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We congratulate Everest on this achievement and look forward to continued collaboration as they launch the product in this important market.”
About Paroxysmal Supraventricular Tachycardia (PSVT)
An estimated three to six million people in China and two million people in the United States are currently diagnosed with PSVT, which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options, with patients often electing to pursue prolonged, burdensome, and costly trips to the emergency department or even undergo invasive cardiac ablation procedures.
About CARDAMYST in the United States
CARDAMYST® (etripamil) nasal spray is approved by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. It is a novel calcium channel blocker nasal spray designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. The product is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT. Currently, etripamil is in Phase 2 development for treatment of PSVT in pediatric patients and Phase 3 development for control of acute atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. For more information, please visit CARDAMYST.com.
U.S. FDA Indication
CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
IMPORTANT SAFETY INFORMATION FOR CARDAMYST (etripamil)
What is CARDAMYST?
CARDAMYST is a prescription medicine used to help restore normal sinus heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat called paroxysmal supraventricular tachycardia (PSVT).
It is not known if CARDAMYST is safe and effective in children.
Do not use CARDAMYST if you:
- are allergic to CARDAMYST or any of its ingredients. See the Patient Information for a complete list of ingredients in CARDAMYST.
- have limitations in activities due to heart failure (moderate to severe heart failure).
- have Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome, or an abnormal heart rhythm pattern called pre-excitation (delta wave) on an electrocardiogram (ECG).
- have sick sinus syndrome without a permanent pacemaker.
- have second degree or higher atrioventricular (AV) block.
Before using CARDAMYST, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of fainting.
- have low blood pressure.
- are pregnant or plan to become pregnant. It is not known if CARDAMYST will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if CARDAMYST passes into your breast milk. You should stop breastfeeding for 12 hours after treatment with CARDAMYST. During this time, pump and throw away your breast milk. Talk to your healthcare provider about the best way to feed your baby after using CARDAMYST.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of CARDAMYST?
CARDAMYST may cause serious side effects, including:
- Fainting due to CARDAMYST effects on blood pressure, heart rate, and electrical activity of the heart. CARDAMYST may cause dizziness and fainting, especially in people with a history of fainting and certain heart problems, or people with a history of fainting during an episode of PSVT. Use CARDAMYST while sitting in a safe area where you will not fall if you become dizzy or lightheaded. Lie down if you feel dizzy or lightheaded after using CARDAMYST. If fainting occurs after using CARDAMYST, caregivers should place you on your back and seek medical help.
The most common side effects of CARDAMYST include:
|
|
These are not all of the possible side effects for CARDAMYST. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information
https://milestonepharma.com/etripamilprescribinginformation.pdf for CARDAMYST.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST® (etripamil) nasal spray, a novel calcium channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in Phase 3 development for the control of symptomatic episodic attacks associated with AFib-RVR. https://milestonepharma.com/
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the commercialization and adoption of CARDAMYST; the ability of Milestone to receive up to
Contact:
Investor Relations
Kevin Gardner, kgardner@lifesciadvisors.com
Media Relations
Rebecca Novak, rnovak@milestonepharma.com
