Ankündigung • Sep 03

Milestone Pharmaceuticals Receives Nmpa Approval for Etripamil Nasal Spray for Psvt in China

Milestone Pharmaceuticals Inc. 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 $2.0 million milestone payment to Milestone Pharmaceuticals. Everest Medicines has an exclusive license with Milestone to develop etripamil nasal spray in Greater China (including Mainland China, Hong Kong, Macau and Taiwan). Under the License Agreement with Everest, Milestone 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 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 [95% CI: 1.578, 5.711]; p = 0.0005). Overall, treatment-emergent adverse events were comparable between the etripamil and placebo groups, and no serious adverse events were reported within 24 hours after dosing across Phase 3 studies. 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. 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. CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. 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. Do not use CARDAMYST if you have limitations in activities due to heart failure (moderate to severe heart failure). Do not use CARDAMYST if you 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). Do not use CARDAMYST if you have sick sinus syndrome without a permanent pacemaker. Do not use CARDAMYST if you 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. If you 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. 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, throat irritation, nasal congestion, nosebleed, and runny nose. 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.

Ankündigung • Nov 08

Milestone Pharmaceuticals Inc. Announces New Data from Phase 3 RAPID Trial of Etripamil Nasal Spray in Patients with PSVT During Late-Breaking Session at the AHA Scientific Sessions 2022

Milestone Pharmaceuticals Inc. announced the presentation of new data from the Phase 3 RAPID clinical trial of etripamil, the Company's investigational calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT) in the at-home setting. The presentation, titled "Self-administered Etripamil for Termination of Spontaneous Paroxysmal Supraventricular Tachycardia: Primary Analysis from the RAPID Study", was featured during a Late-Breaking Clinical Trials session at the American Heart Association (AHA) Scientific Sessions 2022 held November 5-7 in Chicago, IL and virtually. Etripamil, a new chemical entity, is Milestone's lead investigational product. A copy of the presentation will be available in the Publications section of Milestone's website. The multi-center, randomized, double-blind, placebo-controlled RAPID trial enrolled 706 patients across clinical sites in North America and Europe. Patients were randomized 1:1 to a nasal spray of etripamil or placebo, as prompted by symptoms of PSVT and without medical monitoring. To maximize the potential treatment effect of etripamil, patients who did not experience PSVT-symptom relief within 10 minutes were directed to self-administer a repeat dose of study drug. Pre- and post-drug ambulatory electrocardiographic (ECG) data were independently adjudicated. The RAPID trial achieved its primary endpoint, with patients taking etripamil demonstrating a highly statistically significant and clinically meaningful difference in time to PSVT conversion compared to placebo. A Kaplan Meier analysis showed a statistically significantly greater proportion of patients who took etripamil converted within thirty minutes compared to placebo (64.3% vs. 31.2%; hazard ratio [HR] = 2.62; 95% CI 1.66, 4.15; p<0.001). By 90 minutes post-study drug administration, 80.6% of etripamil patients converted versus 60.7% of placebo patients (HR = 1.93; 95% CI 1.349, 2.752; p<0.001) and statistical significance was maintained throughout the five-hour observation window. Significant reductions in time to conversion in patients who took etripamil were evident early and persisted throughout the observation window of the study compared to placebo. The median time to conversion for patients in RAPID who received etripamil was 17.2 minutes compared to 53.3 minutes for patients on placebo. The safety and tolerability data from the RAPID trial continue to support the potential self-administration of etripamil, with findings consistent with those observed in prior trials. The most common randomized treatment emergent adverse events (RTEAEs), which are adverse events (AEs) that occurred within 24 hours of study drug administration, were related to the nasal administration site. Overall, the majority of RTEAEs were reported as mild (68%) to moderate (31%). There were no reported serious AEs related to etripamil. Independently adjudicated ECG data show no cases of 2nd or 3rd degree heart block or significant pauses during at-home drug administration. To date, the Company's overall PSVT clinical program has resulted in more than 1,600 unique patient exposures to etripamil doses of =70 mg. In the RAPID study, patients who were treated with etripamil sought additional medical interventions less frequently (15% vs. 25%; p=0.103) and had fewer emergency department visits (14% vs. 21%; p=0.209) than patients in the placebo arm. These findings were consistent with the Company's previously completed Phase 3 NODE-301 study, in which patients who were treated with etripamil also sought additional medical interventions less frequently (14% vs. 27%; p=0.119) and saw a reduction in emergency department visits (13% vs. 25%; p=0.076) compared to patients in the placebo arm. Notably, analyses of pooled data from the NODE-301 and RAPID trials show that etripamil treatment provided a statistically significant reduction in both the use of additional medical interventions and visits to the emergency department. As previously communicated, the Company believes results from the RAPID trial together with the data from the already completed NODE-301 trial could fulfill the efficacy requirement for a New Drug Application (NDA) submission for etripamil in patients with PSVT. The Company plans to submit an NDA application in mid-2023 pending agency feedback. About Paroxysmal Supraventricular Tachycardia: Paroxysmal supraventricular tachycardia (PSVT) is a condition affecting approximately two million Americans that is characterized by intermittent episodes of a rapid heartbeat that starts and stops suddenly. Episodes of supraventricular tachycardia (SVT) are often associated with symptoms such as palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain intravenous medications, including adenosine, beta-blockers and calcium channel blockers, have long been used for the acute treatment of PSVT. However, these medications must be administered under medical supervision, usually in an emergency department or other acute care setting. About Etripamil: Etripamil, a new chemical entity, is Milestone's lead investigational product. It is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to a medically unsupervised setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and a Phase 2 proof-of-concept trial that is underway in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR).

Gesamte Aktionärsrendite	-80.6%
Zukünftige Dividendenrendite	n/a
Wachstum der Dividende	n/a
Nächster Dividendenzahlungstermin	n/a
Ex-Dividendendatum	n/a
Dividende pro Aktie	n/a
Ausschüttungsquote	n/a

Segment	Dividendenrendite
Unternehmen (MIST)	n/a
Untere 25 % des Marktes (US)	1.4%
Markt Top 25 % (US)	4.1%
Branchendurchschnitt (Pharmaceuticals)	1.9%
Analystenprognose (MIST) (bis zu 3 Jahre)	n/a

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/09/14 21:43
Aktienkurs zum Tagesende	2026/09/14 00:00
Gewinne	2026/06/30
Jährliche Einnahmen	2025/12/31

Paket	Daten	Zeitrahmen	Beispiel US-Quelle ^*
Finanzdaten des Unternehmens	10 Jahre	Gewinn- und Verlustrechnung Kapitalflussrechnung Bilanz	SEC-Formular 10-K SEC-Formular 10-Q
Konsensschätzungen der Analysten	+3 Jahre	Finanzielle Vorausschau Kursziele der Analysten	Analysten Research Berichte Blue Matrix
Marktpreise	30 Jahre	Aktienkurse Dividenden, Splits und Aktionen	ICE-Marktdaten SEC-Formular S-1
Eigentümerschaft	10 Jahre	Top-Aktionäre Insiderhandel	SEC-Formular 4 SEC-Formular 13D
Verwaltung	10 Jahre	Das Führungsteam Direktorium	SEC-Formular 10-K SEC-Formular DEF 14A
Wichtige Entwicklungen	10 Jahre	Ankündigungen des Unternehmens	SEC-Formular 8-K

Analyst	Einrichtung
Olivia Brayer	Cantor Fitzgerald & Co.
Brandon Folkes	H.C. Wainwright & Co.
Patrick Trucchio	H.C. Wainwright & Co.

Milestone Pharmaceuticals Ausschüttungen und Rückkäufe

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Wichtige Informationen

Jüngste Updates zu Dividenden und Rückkäufen

Recent updates

Milestone Pharmaceuticals Receives Nmpa Approval for Etripamil Nasal Spray for Psvt in China

Milestone Pharmaceuticals Presents Data On The Impact Of Paroxysmal Supraventricular Tachycardia (PSVT) On Patients’ Daily Lives And Quality Of Life Between Episodes At ESC Congress 2026

Milestone Pharmaceuticals Initiates Pivotal Phase 3 Trial Of Etripamil Nasal Spray For Self-Administered Treatment Of Atrial Fibrillation With Rapid Ventricular Rate

Consensus revenue estimates decrease by 14%, EPS upgraded

Milestone Pharmaceuticals: Here Comes The Revenue Ramp

New minor risk - Profitability

Forecast to breakeven in 2028

Milestone Pharmaceuticals Inc. has filed a Follow-on Equity Offering in the amount of $100 million.

Milestone Pharmaceuticals Inc. to Report Q1, 2026 Results on May 13, 2026

Milestone Pharmaceuticals Inc., Annual General Meeting, Jun 10, 2026

CEO, President & Director recently sold US$82k worth of stock

CEO, President & Director notifies of intention to sell stock

FDA Approval And Shift To Self Administered Care Will Reshape This Cardiovascular Opportunity

Milestone Pharmaceuticals Announces Registry to Generate Real-World Evidence on Cardamyst Nasal Spray in Patients with Psvt

Payer Constraints On Self Administered PSVT Care Will Challenge Near Term Progress Yet Offer Upside

Insufficient new directors

New minor risk - Share price stability

Consensus EPS estimates upgraded to US$0.41 loss

Acute Cardiovascular Self Administration Will Reshape Treatment Patterns And Support Long Term Thesis

Milestone Pharmaceuticals Inc. to Report Q4, 2025 Results on Mar 20, 2026

Milestone Pharmaceuticals Inc. Appoints David Sandoval as General Counsel and Chief Compliance Officer

New minor risk - Share price stability

CEO, President & Director exercised options and sold US$67k worth of stock

Milestone Pharmaceuticals Inc. Announces U.S. Availability of Cardymst™? (Etripamil) Nasal Spray

CEO, President & Director notifies of intention to sell stock

Milestone Pharmaceuticals Announces Acceptance of Marketing Authorization Application for Etripamil Nasal Spray in PSVT by the European Medicines Agency

Milestone Pharmaceuticals Inc. Receives FDA Approval of Cardymst™? (etripamil) as First and Only Self-Administered Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)

Does Milestone Pharmaceuticals (NASDAQ:MIST) Have A Healthy Balance Sheet?

Milestone Pharmaceuticals to Present New Analysis from Investigational Etripamil Nasal Spray Clinical Trials for PSVT at the American Heart Association Scientific Sessions 2025

New major risk - Shareholder dilution

Milestone Pharmaceuticals Inc. Announces FDA Acceptance of the Company's Response to the CRL for CARDAMYST™? (Etripamil) Nasal Spray

Milestone Pharmaceuticals Submits Response to the FDA’s CRL for CARDAMYST (etripamil) Nasal Spray for PSVT Following Type A Meeting

New major risk - Negative shareholders equity

New major risk - Revenue and earnings growth

Consensus revenue estimates decrease by 50%, EPS upgraded

New minor risk - Market cap size

Price target increased by 21% to US$12.67

Milestone Pharmaceuticals Inc. Announces FDA Issues Complete Response Letter for Etripamil for PSVT

Milestone Pharmaceuticals Inc., Annual General Meeting, Jun 10, 2025

Consensus EPS estimates fall by 26%

New major risk - Financial position

New minor risk - Profitability

No longer forecast to breakeven

New minor risk - Share price stability

Forecast to breakeven in 2027

Price target increased by 24% to US$13.00

Does Milestone Pharmaceuticals (NASDAQ:MIST) Have A Healthy Balance Sheet?

Milestone Pharmaceuticals Appoints Joseph Papa to Its Board of Directors

Milestone Pharmaceuticals Inc., Annual General Meeting, Aug 28, 2024

Milestone Pharmaceuticals Inc. Refreshes Board of Directors

Here's Why Shareholders Should Examine Milestone Pharmaceuticals Inc.'s (NASDAQ:MIST) CEO Compensation Package More Closely

New minor risk - Market cap size

Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for CARDAMYST™

New minor risk - Profitability

Price target increased by 24% to US$13.00

Forecast to breakeven in 2026

New major risk - Shareholder dilution

Milestone Pharmaceuticals Announces Etripamil Data Demonstrating Patients’ Ability to Self-Manage Recurring PSVT, Presented at The American College of Cardiology Annual Meeting

Price target increased by 21% to US$13.00

Milestone Pharmaceuticals Inc. Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia

Milestone Pharmaceuticals Inc., Annual General Meeting, Jun 13, 2024

Full year 2023 earnings: EPS misses analyst expectations

New major risk - Revenue and earnings growth

No longer forecast to breakeven

New minor risk - Shareholder dilution

Milestone Pharmaceuticals Inc. has completed a Follow-on Equity Offering in the amount of $29.966667 million.

Milestone Pharmaceuticals Inc. Announces Plan to Resubmit NDA for Etripamil for the Treatment of Psvt

Price target decreased by 21% to US$10.75

Forecast to breakeven in 2026

Milestone Pharmaceuticals Receives Refusal to File Letter from U.S. FDA for New Drug Application for Etripamil in the Treatment of PSVT

Price target increased by 13% to US$16.00

Alta Advisers Sends a Letter to Milestone Pharmaceuticals

Insufficient new directors

New minor risk - Market cap size

Milestone Pharmaceuticals Inc. Announces Submission of New Drug Application to the U.S. FDA for Etripamil