Milestone Pharmaceuticals Announces RESET-PSVT Registry to Generate Real-World Evidence on CARDAMYST Nasal Spray in Patients with PSVT

About this update from Milestone Pharmaceuticals Inc.

MONTREAL , CHARLOTTE - Milestone Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, announced details on RESET-PSVT, a planned Phase 4, multicenter, prospective, observational registry intended to generate real-world evidence on the use of CARDAMYST (etripamil) nasal spray in adults with paroxysmal supraventricular tachycardia (PSVT). Registry of Etripamil (CARDAMYST) Studies Evaluating Treatment in Paroxysmal Supraventricular Tachycardia (RESET-PSVT): Study Design,' was presented in a poster session at the Preventive Cardiovascular Nurses Association (PCNA) 2026 Cardiovascular Nursing Symposium in Scottsdale, Arizona . The study will be led by the Duke Clinical Research Institute (DCRI). CARDAMYST was approved by the U.S. Food and Drug Administration (FDA) in December 2025 and is now commercially available in the United States . RESET-PSVT is expected to enroll an estimated 450 adult patients across approximately 20 electrophysiology and cardiology sites, with enrollment beginning by the end of 2026. The registry is designed to evaluate patients who have been prescribed CARDAMYST as well as patients prescribed or given other therapies, with enrolled patients and their healthcare providers completing patient- and provider-outcome surveys, respectively. 'RESET-PSVT will be important in further expanding the evidence base for CARDAMYST beyond our controlled clinical trials and into real-world clinical practice,' said David Bharucha , M.D., PhD, Chief Medical Officer of Milestone Pharmaceuticals . 'This registry is designed to help us better understand how CARDAMYST is being used in adults with PSVT in routine care, while also capturing patient-reported outcomes that can provide meaningful insight into how patients are living with this condition. In addition to evaluating treatment patterns, we believe the study has the potential to deepen our understanding of quality of life, episode burden and healthcare utilization over time. This is the first registry of its kind in the PSVT space, and we expect it to inform healthcare providers, support future scientific dialogue and further characterize the value of CARDAMYST in the acute management of PSVT.' The study's primary endpoint is to characterize patterns of use of CARDAMYST in PSVT management, including frequency of PSVT episodes, frequency of use of CARDAMYST, number of doses administered per episode and triggers for use. Secondary endpoints include comparisons between CARDAMYST and non-CARDAMYST users across patient-reported quality of life, healthcare utilization and episode characteristics. Exploratory analyses are expected to evaluate prescribing and use patterns across patient subgroups, along with qualitative analysis of participant experience. 'We believe this registry is important because it is designed to capture meaningful patient-reported outcomes in a contemporary PSVT population,' said Sean D. Pokorney , M.D., MBA, RESET-PSVT Lead Investigator and Assistant Professor of Medicine at Duke University School of Medicine and the Duke Clinical Research Institute (DCRI). 'In addition to informing how CARDAMYST is being used in practice, these data may provide valuable insight into quality of life, healthcare utilization and the broader patient experience over time.' RESET-PSVT is intended to generate prospective evidence to inform the real-world use of recently approved CARDAMYST and demonstrate its potential impact on the acute management of PSVT. Results are expected to be shared at scientific conferences and in peer-reviewed publications in the future. In addition, an expert theater 'Discover the First and Only FDA-Approved Nasal Spray to Treat PSVT in Adults,' sponsored by Milestone, will take place April 11 during the PCNA symposium. Product Theater : Discover the First and Only FDA-Approved Nasal Spray to Treat PSVT in Adults Presenter: Eleanor C. Vierra , NP, ACNP-C, Cardiovascular Acute Care Nurse Practitioner Day/Time: Saturday, April 11 , 8:00am MT 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 control of acute atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. 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 expectations in regard to the efficacy of etripamil 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 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: Kevin Gardner Email: [email protected] Rebecca Novak Email: [email protected] (C) 2026 Electronic News Publishing, source ENP Newswire

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