Milestone Pharmaceuticals Announces Acceptance of Marketing Authorization Application for Etripamil Nasal Spray in PSVT by the European Medicines Agency
Rhea-AI Summary
Milestone Pharmaceuticals (Nasdaq: MIST) announced the EMA accepted its Marketing Authorization Application (MAA) for etripamil nasal spray (brand name TACHYMIST) for treatment of paroxysmal supraventricular tachycardia (PSVT).
A regulatory decision is expected by Q1 2027. If approved, etripamil is intended as a rapid, patient self‑administered nasal spray for PSVT outside healthcare settings and the MAA uses the global clinical data that supported prior U.S. FDA approval.
The company highlighted a potential patient population of about 2 million people in Europe who suffer from PSVT.
Positive
- EMA MAA accepted for etripamil nasal spray
- Regulatory decision expected by Q1 2027
- Addresses ~2 million PSVT patients in Europe
- Uses the global clinical data supporting U.S. FDA approval
Negative
- Approval is pending; commercial use depends on EMA decision
- Etripamil remains investigational until European approval is granted
- European launch timing uncertain until EMA decision in Q1 2027
News Market Reaction
On the day this news was published, MIST gained 1.49%, reflecting a mild positive market reaction. Argus tracked a peak move of +2.7% during that session. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $3M to the company's valuation, bringing the market cap to $192M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Biotech peers show mixed moves: ACOG -5.22%, VTYX -8.11%, KYTX -8.45% while GLSI gained 7.56% and CYBN was roughly flat at 0.12%, pointing to stock-specific rather than clear sector-wide direction for MIST.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 17 | Device partner news | Positive | -3.3% | Aptar device highlighted as delivery system for FDA‑approved CARDAMYST nasal spray. |
| Dec 12 | FDA approval | Positive | -18.3% | FDA approved CARDAMYST as first self‑administered nasal spray for PSVT in adults. |
| Dec 02 | Inducement grants | Neutral | -1.5% | Stock option inducement awards to new employees under the 2021 Inducement Plan. |
| Nov 12 | Earnings and update | Positive | +1.1% | Q3 2025 results, cash of <b>$82.6M</b> and regulatory progress toward CARDAMYST PDUFA date. |
| Nov 04 | Inducement grants | Neutral | -2.2% | Additional stock option inducement grants under Nasdaq Listing Rule 5635(c)(4). |
Recent positive regulatory milestones, including FDA approval of CARDAMYST, were followed by negative price reactions, suggesting a tendency for the stock to sell off on good news.
Over the last few months, Milestone advanced etripamil from regulatory review to U.S. approval. An FDA approval for CARDAMYST on Dec 12, 2025 was followed by device-partner news on Dec 17, 2025. Earlier, Q3 2025 results highlighted $82.6 million in liquidity and preparations for launch, alongside equity financing and royalty arrangements. Multiple inducement option grants in Nov–Dec 2025 reflected ongoing hiring. Today’s EMA MAA acceptance fits a continued path of expanding etripamil’s reach beyond the U.S.
Market Pulse Summary
This announcement highlights acceptance of Milestone’s MAA for etripamil nasal spray by the EMA, with a potential decision by Q1 2027 for a European PSVT population of about 2 million patients. It follows prior U.S. approval and reflects ongoing efforts to globalize the franchise. Context from recent filings underscores the importance of monitoring cash resources, commercial rollout progress, and any additional regulatory interactions in major markets.
Key Terms
marketing authorization application regulatory
european medicines agency regulatory
paroxysmal supraventricular tachycardia medical
calcium channel blocker medical
AI-generated analysis. Not financial advice.
- European decision on approval is expected by Q1 2027
- If approved, etripamil nasal spray is expected to offer patients a safe and effective self-administered treatment option for PSVT outside of the healthcare setting
MONTREAL and CHARLOTTE, N.C., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) seeking the approval of etripamil nasal spray, developed to be the first rapid, reliable option in the treatment of paroxysmal supraventricular tachycardia (PSVT) outside of the healthcare setting. Etripamil, which has the conditionally approved brand name TACHYMIST™ in Europe, is an investigational, novel calcium channel blocker delivered via a nasal spray by the patient for the potential treatment of PSVT and other cardiac arrhythmias. A decision on approval is expected by the first quarter of 2027.
“Following guidance from the EMA, this MAA incorporates the global clinical data package that supported the U.S. Food and Drug Administration approval of etripamil for the treatment of PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “TACHYMIST could become the first approved patient self-administered therapy representing a meaningful step forward in patient care for the approximately two million people suffering from PSVT in Europe.”
About the Pivotal RAPID Phase 3 Trial
The MAA submission is supported by efficacy, safety, and tolerability results from a robust clinical trial program based on data from more than 1,800 participants and more than 2,000 episodes of PSVT. This includes the successful Phase 3 RAPID trial, a global, randomized, double-blind comparison of etripamil vs. placebo, published in The Lancet in 2023. In clinical studies, participants using etripamil were two times more likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster compared with placebo. The RAPID trial achieved its primary endpoint with
A consistent safety profile and treatment effects were observed across all subgroups, including participants concurrently on beta blockers or calcium channel blockers. The most frequent adverse events occurring in ≥
About Paroxysmal Supraventricular Tachycardia
An estimated two million people in the United States, and an additional two million people in Europe, 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 requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures.
About Etripamil
Etripamil 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 under the brand name CARDAMYST™. Etripamil is a novel calcium channel blocker nasal spray designed as a self-administered rapid response therapy for patients, thereby bypassing the need for direct medical oversight. Etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. TACHYMIST™, the conditionally approved brand name for etripamil nasal spray in Europe, 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 acute treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing 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 development for the treatment of symptomatic episodic attacks associated with AFib-RVR.
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: timing and expectations regarding the EMA’s review of the MAA, including the timing around a decision on approval; Milestone’s expectations on the market for PSVT in Europe; expectations in regards to etripamil’s efficacy; etripamil’s potential as a novel treatment option to help patients with PSVT; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether Milestone’s future interactions with the EMA will have satisfactory outcomes; whether and when, if at all, Milestone’s MMA for etripamil will be approved by the EMA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of Milestone’s clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in the Middle East and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended September 30, 2025, in each case under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Investor Relations
Kevin Gardner, kgardner@lifesciadvisors.com
Media Relations
Rebecca Novak, rnovak@milestonepharma.com
FAQ
What did Milestone announce about etripamil (MIST) on January 6, 2026?
When does the EMA decision for etripamil (MIST) expect to occur?
What would approval of etripamil (MIST) mean for PSVT patients in Europe?
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