Milestone Pharmaceuticals to Present Data on CARDAMYST™ (etripamil) Nasal Spray at the 2026 American College of Cardiology Annual Scientific Session

Rhea-AI Summary

Milestone (Nasdaq: MIST) will present data at ACC.26 (March 28-30, 2026) showing minimal blood pressure effects after intranasal etripamil (CARDAMYST) test dosing.

Phase 3 analysis reported mean systolic BP change ~1.8 mmHg (single 70 mg, N=440) and TEAE rates of hypotension 0.4% and syncope 0.2% (N=1,610), supporting potential safe self-administration for adults with PSVT.

Positive

• FDA approval (Dec 2025) as first self‑administered nasal PSVT therapy
• Mean systolic BP change only 1.8 mmHg after single 70 mg test dose
• Low TEAE rates: hypotension 0.4% and syncope 0.2% (N=1,610)

Negative

• Calcium channel blocker class carries residual risk of hypotension
• Syncope events occurred in 0.2% of patients (N=1,610)

Key Figures

Single-dose BP change: 1.8 mmHg (SD 11.2) Repeat-dose BP change: 0.0 mmHg (SD 12.0) Phase 3 population: 1,610 patients +5 more

8 metrics

Single-dose BP change 1.8 mmHg (SD 11.2) Mean systolic BP change over 30 min after 70 mg etripamil (N=440)

Repeat-dose BP change 0.0 mmHg (SD 12.0) Mean systolic BP change over 45 min for repeat doses (N=714)

Phase 3 population 1,610 patients Patients assessed for hypotension and syncope within 24 hours

Hypotension TEAEs 0.4% (N=7) Treatment-emergent hypotension events within 24 hours in Phase 3 trials

Syncope TEAEs 0.2% (N=4) Treatment-emergent syncope events within 24 hours; 2 pre-dose

Etripamil dose 70 mg Intranasal test dose used in NODE-301 parts 1–3

Poster time 10:06–10:13am CT Moderated poster on March 29, 2026 at ACC.26

Expert Theater time 12:00–1:00pm CT Sponsored Expert Theater on March 30, 2026 at ACC.26

Market Reality Check

Price: $1.70 Vol: Volume 763,272 is at 0.56...

low vol

$1.70 Last Close

Volume Volume 763,272 is at 0.56x the 20-day average, indicating subdued trading interest. low

Technical Shares at $1.70 are trading below the $1.90 200-day moving average, reflecting a weak longer-term trend.

Peers on Argus

MIST fell 2.86% while momentum-screened peers like GLSI and SGMO showed gains of...

2 Up

MIST fell 2.86% while momentum-screened peers like GLSI and SGMO showed gains of about 4.5%, pointing to stock-specific dynamics rather than a sector-wide move.

Historical Context

5 past events · Latest: Mar 12 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 12	Earnings timing update	Neutral	+2.3%	Announced date and call details for Q4 and full-year 2025 results.
Feb 26	Conference participation	Neutral	-0.6%	Planned presentation at TD Cowen healthcare conference with webcast access.
Feb 10	Executive appointment	Positive	+1.1%	Appointed new General Counsel and CCO alongside CARDAMYST commercial launch.
Feb 03	Equity inducement grants	Neutral	+0.5%	Granted 419,000 stock options to new employees under inducement plan.
Jan 26	Product launch update	Positive	-2.0%	Announced U.S. commercial availability of CARDAMYST nasal spray for PSVT.

Pattern Detected

Recent news has generally produced modest single-day moves, with both positive and neutral items sometimes met by small gains or mild pullbacks.

Recent Company History

Over the past few months, Milestone has transitioned CARDAMYST from FDA approval in December 2025 to U.S. commercial availability announced on Jan 26, 2026. Subsequent news focused on equity inducement grants, key leadership appointments aligned with the CARDAMYST launch, a healthcare conference appearance, and an upcoming Q4 and full-year 2025 earnings date. Today’s ACC.26 safety data presentation reinforces the product’s profile in PSVT and builds on the commercial launch narrative highlighted in prior announcements.

Market Pulse Summary

This announcement highlights detailed Phase 3 safety data for intranasal etripamil, showing minimal ...

Analysis

This announcement highlights detailed Phase 3 safety data for intranasal etripamil, showing minimal blood pressure changes and very low rates of hypotension and syncope in 1,610 patients self-treating PSVT. It builds on prior milestones: FDA approval in December 2025 and U.S. commercial availability announced in January 2026. Investors may watch upcoming earnings, prescription uptake, and further clinical data, including investigation in atrial fibrillation with rapid ventricular rate, to gauge the drug’s commercial and clinical trajectory.

Key Terms

paroxysmal supraventricular tachycardia, psvt, atrial fibrillation, sinus rhythm, +3 more

7 terms

paroxysmal supraventricular tachycardia medical

"Minimal Blood Pressure Effects of Intranasal Etripamil in Trials for Paroxysmal Supraventricular Tachycardia (PSVT)"

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

"new treatment option for adults with symptomatic 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.

atrial fibrillation medical

"under investigation for atrial fibrillation with rapid ventricular rate."

Atrial fibrillation is a common heart rhythm problem in which the heart’s upper chambers quiver instead of delivering steady, strong pumps, like a washing machine on an unbalanced cycle. It matters to investors because it increases use of medications, medical devices, hospital care and long‑term monitoring, drives demand for new treatments and diagnostics, and can affect healthcare costs, regulatory decisions and revenue prospects across drug, device and insurance markets.

sinus rhythm medical

"observed following an etripamil test dose, while the patients were in 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.

hypotension medical

"potential hypotension is a known class effect of calcium channel blockers"

Hypotension is abnormally low blood pressure that reduces the flow of blood and oxygen to the body’s organs, which can cause dizziness, fainting, fatigue or in severe cases organ damage. For investors, it matters because drugs, devices or procedures that cause or treat hypotension can change clinical trial outcomes, safety labels, prescribing use and healthcare costs—similar to a drop in water pressure that can disrupt an entire building’s plumbing.

treatment-emergent adverse events medical

"syncope treatment-emergent adverse events (TEAEs) across Phase 3 trials"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

phase 3 medical

"this analysis from Milestone’s etripamil Phase 3 program shows that etripamil had a minimal impact"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

MONTREAL and CHARLOTTE, N.C., March 16, 2026 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that a moderated poster presentation titled “Minimal Blood Pressure Effects of Intranasal Etripamil in Trials for Paroxysmal Supraventricular Tachycardia (PSVT)” will be featured at the 2026 American College of Cardiology Annual Scientific Session (ACC.26), March 28-30^th in New Orleans, La. An Expert Theater will also be conducted at ACC.26, providing a deeper look at this new treatment option for adults with symptomatic PSVT.

“Although potential hypotension is a known class effect of calcium channel blockers, this analysis from Milestone’s etripamil Phase 3 program shows that etripamil had a minimal impact on blood pressure after test dosing and very low rates of hypotension,” said David Bharucha, M.D., PhD, Chief Medical Officer of Milestone Pharmaceuticals. “We believe these data support the potential for safe self-administration by patients of intranasal etripamil for PSVT outside the clinical setting.”

Data Highlights

• Etripamil (CARDAMYST™), a novel calcium channel blocker (CCB) nasal spray, was FDA-approved as the first and only self-administered treatment for adults with symptomatic PSVT in December 2025 and is under investigation for atrial fibrillation with rapid ventricular rate. The Phase 3 trials that evaluated the product in PSVT included NODE-301 parts 1-3, NODE-302, and NODE-303.
• CCBs are associated with a risk of hypotension, therefore blood pressure (BP) or symptoms of hypotension were diligently assessed.
• Mean heart rate (HR) and BP change from baseline were analyzed for 30 to 45 minutes post-test dose of etripamil 70 mg in NODE 301 parts 1-3. Patients self-administered either a single or repeat TD (2 x 70 mg). The authors report a descriptive analysis of symptoms of potential hypotension or syncope treatment-emergent adverse events (TEAEs) across Phase 3 trials of PSVT episodes, self-treated outside of the clinical setting.
• Minimal change from baseline HR and BP was observed following an etripamil test dose, while the patients were in sinus rhythm. Mean systolic BP change was 1.8 mmHg (SD 11.2) over 30 min for single 70 mg dose (N=440) and 0.0 mmHg (SD 12.0) over 45 min for repeat doses (N=714).
• Among 1,610 patients, TEAEs of hypotension and syncope within 24 hours were 0.4% (N=7) and 0.2% (N=4), respectively. Two of the four AEs of syncope occurred prior to drug administration. All TEAEs resolved without medical intervention.
• The authors concluded that although CCBs generally carry a potential risk of hypotension, these data demonstrate minimal BP reduction during test dose and rare symptoms of hypotension or syncope, supporting the potential safe self-administration of etripamil for PSVT treatment.

Presentation Details
Moderated Poster Presentation Title:	Minimal Blood Pressure Effects of Intranasal Etripamil in Trials for Paroxysmal Supraventricular Tachycardia
Presenter:	Narendra Singh, M.D., Clinical Assistant Professor, Medical College of Georgia at Augusta University and Mercer University, Atlanta. Director, Clinical Research-NSC Research
Date and Time:	Sunday, March 29, 2026, 10:06 – 10:13am CT
Location:	Moderated Poster Theater 10, Posters, Hall E
Presentation Number:	1089-09
Separately, a sponsored Expert Theater will be held at ACC.26 to explore the potential role of CARDAMYST as an emerging therapy to treat symptomatic episodes of PSVT in adults.
Presentation Details:
Expert Theater:	Discover the First and Only FDA-Approved Nasal Spray to Treat PSVT in Adults*
Presenter:	Farhad Rafii, M.D., Clinical Study Investigator
Date and Time:	Monday, March 30, 2026, 12:00-1:00pmCT
Location:	IET #3 (Booth 2863)
*This event is not part of ACC.26, as planned by its Program Committee, and does not qualify for continuing medical education (CME), continuing nursing education (CNE) or continuing education (CE) credit.

Attendees can learn more about CARDAMYST by visiting Booth #319.

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 control 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 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 development for the control 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: Milestone’s exp expectations in regards to etripamil’s efficacy and its safe self-administration by patients outside the clinical setting; Milestone’s research, development and regulatory plans for etripamil; 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

FAQ

What did Milestone (MIST) report about blood pressure effects of etripamil at ACC.26?

The presentation reports minimal blood pressure effects after etripamil test dosing. According to the company, mean systolic BP change was 1.8 mmHg for a single 70 mg dose (N=440), supporting limited BP impact in Phase 3 PSVT trials.

How common were hypotension and syncope in Milestone's Phase 3 etripamil data?

Hypotension and syncope were rare in the pooled Phase 3 analysis. According to the company, hypotension TEAEs were 0.4% and syncope TEAEs 0.2% among 1,610 patients, with all events resolving without medical intervention.

Does the ACC.26 presentation change CARDAMYST (MIST) self‑administration guidance for PSVT?

The data support potential safe self‑administration of CARDAMYST for adults with PSVT. According to the company, minimal BP reduction and low TEAE rates underpin the case for out‑of‑clinic self‑use.

When and where will Milestone present the etripamil blood pressure analysis at ACC.26?

The moderated poster is scheduled for March 29, 2026 at 10:06 AM CT in Moderated Poster Theater 10. According to the company, presentation number 1089‑09 will cover BP effects in Phase 3 trials.

What specific Phase 3 trials were included in Milestone's etripamil safety analysis?

The analysis pooled results from NODE‑301 parts 1‑3, NODE‑302, and NODE‑303. According to the company, these Phase 3 trials evaluated intranasal etripamil in self‑treated PSVT episodes outside clinical settings.