Milestone Pharmaceuticals Announces U.S. Availability of CARDAMYST™ (etripamil) Nasal Spray, the First and Only FDA-Approved Self-Administered Treatment for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)

Rhea-AI Summary

Milestone Pharmaceuticals (Nasdaq: MIST) announced U.S. commercial availability of CARDAMYST (etripamil) nasal spray, a prescription, self‑administered treatment indicated to convert acute symptomatic paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

The FDA approved CARDAMYST on December 12, 2025. The product is now available through U.S. retail pharmacies, with a national sales force planned for deployment in mid‑February 2026. Launch support includes a patient assistance platform offering benefits verification, reimbursement support, and copay assistance; eligible commercially insured patients are expected to have a $25 copay cap.

Positive

• FDA approval received on December 12, 2025 (first PSVT approval in >30 years)
• Product now available through U.S. retail pharmacies
• National sales force deployment planned for mid‑February 2026
• Patient assistance program with benefits verification, reimbursement support, and copay help
• Expected $25 copay cap for eligible commercially insured patients

Negative

• Formulary coverage not finalized—company is continuing negotiations with insurers for placement and coverage
• Copay cap limited to eligible commercially insured patients, leaving coverage uncertainty for others

News Market Reaction

-2.02%

1 alert

-2.02% News Effect

On the day this news was published, MIST declined 2.02%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Copay cap: $25 Sales force launch: mid-February 2026 FDA approval date: December 12, 2025 +1 more

4 metrics

Copay cap $25 Expected cap for eligible commercially insured CARDAMYST patients

Sales force launch mid-February 2026 National sales force deployment timing for CARDAMYST commercialization

FDA approval date December 12, 2025 FDA approval of CARDAMYST for PSVT in adults

Treatment gap more than 30 years First FDA-approved PSVT treatment in over 30 years

Market Reality Check

Price: $1.89 Vol: Volume 2,126,422 is below...

low vol

$1.89 Last Close

Volume Volume 2,126,422 is below the 20-day average of 3,374,993 (relative volume 0.63). low

Technical Shares at $1.98 are trading above the $1.80 200-day MA but remain 35.29% below the 52-week high and well above the 52-week low.

Peers on Argus

MIST was down 0.5% pre-news while key peer GLSI appeared in momentum scans, up a...

1 Up

MIST was down 0.5% pre-news while key peer GLSI appeared in momentum scans, up about 5.03%. With only one peer in momentum and it moving opposite to MIST, the setup points to stock-specific dynamics rather than a sector-wide move.

Historical Context

5 past events · Latest: Jan 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	EMA MAA acceptance	Positive	+1.5%	EMA accepted MAA for etripamil nasal spray in PSVT with Q1 2027 decision.
Dec 17	Device partnership	Positive	-3.3%	Aptar announced its Bidose Nasal System as CARDAMYST’s FDA-approved delivery device.
Dec 12	FDA approval	Positive	-18.3%	FDA approved CARDAMYST nasal spray as first self-administered PSVT treatment in 30+ years.
Dec 02	Inducement grants	Neutral	-1.5%	Granted 30,000 stock options to new hires under inducement plan with four-year vesting.
Nov 12	Q3 2025 earnings	Neutral	+1.1%	Reported Q3 2025 results, $82.6M cash and preparation for CARDAMYST PDUFA decision.

Pattern Detected

Recent history shows that even strongly positive regulatory milestones, including FDA approval of CARDAMYST, have sometimes been met with negative price reactions, while other regulatory and earnings updates saw modest gains.

Recent Company History

Over the past few months, Milestone moved from preparing for a CARDAMYST FDA decision to securing full approval and advancing global market access. The company reported Q3 2025 results with $82.6 million in liquidity and detailed launch preparations ahead of the December 13, 2025 PDUFA date. FDA approval of CARDAMYST for PSVT on December 12, 2025 was followed by EMA acceptance of an MAA for Europe, targeting a decision by Q1 2027. Today’s U.S. retail availability update continues that commercialization trajectory.

Market Pulse Summary

This announcement marks the U.S. retail availability of CARDAMYST, Milestone’s first commercial prod...

Analysis

This announcement marks the U.S. retail availability of CARDAMYST, Milestone’s first commercial product for PSVT, backed by a national sales force rollout in mid‑February 2026 and an expected $25 copay cap for eligible patients. It builds on FDA approval in December 2025 and EMA’s MAA acceptance. Investors may watch insurer coverage decisions, the effectiveness of the assistance program, and early prescription trends as key indicators of launch execution.

Key Terms

paroxysmal supraventricular tachycardia, psvt, sinus rhythm, fda, +2 more

6 terms

paroxysmal supraventricular tachycardia medical

"episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults"

A sudden, brief episode of an abnormally fast heartbeat that starts in the upper chambers of the heart and then stops on its own; think of it like an electrical short that causes the heart to race for minutes to hours before returning to normal. Investors care because its prevalence and the effectiveness of treatments drive demand for drugs, medical devices, hospital services and clinical trials, which can affect revenues, regulatory risk and healthcare spending trends.

psvt medical

"self-administered treatment for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)"

Paroxysmal supraventricular tachycardia (PSVT) is a condition in which the heart suddenly starts beating very fast because electrical signals loop abnormally in the upper chambers, with episodes that often begin and stop abruptly like an engine that unexpectedly revs. Investors should care because PSVT can cause temporary incapacity, require medical treatment or hospitalization for key personnel, affect workforce productivity, and influence companies developing related diagnostics, drugs, or devices.

sinus rhythm medical

"for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm"

Sinus rhythm is the heart’s normal beating pattern generated by its natural pacemaker, like a metronome setting a steady tempo. For investors, it's a simple indicator of healthy cardiac function that can affect patient outcomes, clinical trial results, device performance and regulatory assessments; deviations from sinus rhythm may signal safety or efficacy issues that influence a company’s clinical and commercial prospects.

fda regulatory

"The U.S. Food and Drug Administration (FDA) approved CARDAMYST on December 12, 2025"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

copay financial

"For eligible commercially insured patients, copays are expected to be capped at $25"

A copay is a fixed out-of-pocket amount a patient pays at the time of a medical visit, prescription pick-up, or treatment, with their insurance covering the rest. Think of it as a set “share” of the bill, like an entry fee you pay while the insurer pays the remainder. For investors, copays influence how often patients use services and drugs, affect revenue and cash flow for providers and pharmacies, and can shape demand for treatments and insurance plans.

formulary placement financial

"Milestone continues to negotiate with insurers for formulary placement and coverage"

Formulary placement is how a health insurer or pharmacy chooses and ranks a drug on its approved list of medicines, determining how easily patients can get it, how much they pay, and whether special approvals are needed. For investors, placement acts like a store shelf position: a favorable spot or lower patient cost usually boosts sales and revenue potential, while a restricted or high-cost tier can sharply limit a drug’s commercial uptake.

AI-generated analysis. Not financial advice.

• CARDAMYST is now conveniently available to patients through retail pharmacies
• National sales force hired with promotional launch in mid-February
• Expected $25 copay cap for eligible commercially insured patients
• Launch supported by comprehensive patient assistance program offering benefits verification and reimbursement support

MONTREAL and CHARLOTTE, N.C., Jan. 26, 2026 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced that CARDAMYST™ (etripamil) nasal spray, its first commercial product, is now available through U.S. retail pharmacies. CARDAMYST is a prescription medication indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Implementation of a rapid commercialization plan is underway with a national sales force to be deployed in mid-February 2026.

CARDAMYST will launch with the support of a patient assistance platform as Milestone continues to negotiate with insurers for formulary placement and coverage. The program provides benefits verification, reimbursement support, and copay assistance for most patients with commercial insurance that covers CARDAMYST, helping to reduce financial and administrative barriers to treatment. For eligible commercially insured patients, copays are expected to be capped at $25, reinforcing Milestone’s commitment to making CARDAMYST affordable for patients who need it.

“Many patients have been waiting for help to take greater control of their PSVT condition. Now that CARDAMYST is available, patients have access to a convenient, self-administered option designed to treat episodes of PSVT wherever and whenever they occur,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “Beyond availability, our team continues to engage insurers with the goal of having CARDAMYST widely covered and affordable.”

The U.S. Food and Drug Administration (FDA) approved CARDAMYST on December 12, 2025, marking the first FDA approval of a treatment for PSVT in more than 30 years.

About Paroxysmal Supraventricular Tachycardia (PSVT)
An estimated 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
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 acute treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. For more information, please visit CARDAMYST.com.

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:

nasal discomfort nasal congestion runny nose

throat irritation nosebleed

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 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: the retail availability of CARDAMYST; Milestone’s expectations regarding the promotional launch of CARDAMYST; expectations in regards to etripamil’s efficacy; Milestone’s ability to make CARDAMYST widely covered and affordable, including any applicable copay caps; 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.

Contact: 

Investor Relations 
Kevin Gardner, kgardner@lifesciadvisors.com 

Media Relations 
Rebecca Novak, rnovak@milestonepharma.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/55ffc562-1e02-4b4f-8ace-822b39d104f4

FAQ

When did Milestone (MIST) receive FDA approval for CARDAMYST?

The FDA approved CARDAMYST on December 12, 2025.

Is CARDAMYST (MIST) available at U.S. pharmacies now?

Yes. CARDAMYST is now available through U.S. retail pharmacies.

When will Milestone deploy a national sales force for CARDAMYST (MIST)?

A national sales force is planned to be deployed in mid‑February 2026.

What patient cost support does Milestone offer for CARDAMYST (MIST)?

Milestone launched a patient assistance platform with benefits verification, reimbursement support, and expected copay caps of $25 for eligible commercially insured patients.

Will CARDAMYST (MIST) be covered by insurers immediately?

Coverage is not finalized; Milestone is continuing to negotiate with insurers for formulary placement and coverage.