Milestone Pharmaceuticals Provides 2025 Corporate Outlook and Will Host Investor Event on February 25 in NYC
Milestone Pharmaceuticals (MIST) has outlined its strategic priorities for 2025, highlighting the upcoming PDUFA date of March 27, 2025 for CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT). The company is preparing for a mid-2025 commercial launch, pending FDA approval.
The company has strengthened its launch leadership team with Jeff Moore as VP of Sales and plans to deploy approximately 60 sales professionals focusing on cardiologists, electrophysiologists, and cardiac-focused primary care physicians. Sales representatives will be hired around FDA approval time.
Additionally, Milestone plans to initiate a Phase 3 trial for etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) in H1 2025. The study will evaluate a self-administered, repeat-dose regimen of 70 mg/dose, targeting approximately 150 events in patients with symptomatic episodes.
Milestone Pharmaceuticals (MIST) ha delineato le sue priorità strategiche per il 2025, evidenziando la prossima data PDUFA del 27 marzo 2025 per il spray nasale CARDAMYST™ (etripamil) per la Tachicardia Supraventricolare Parossistica (PSVT). L'azienda si sta preparando per un lancio commerciale previsto per metà 2025, in attesa dell'approvazione della FDA.
L'azienda ha rafforzato il suo team di leadership per il lancio con Jeff Moore come VP delle Vendite e prevede di schierare circa 60 professionisti delle vendite focalizzati su cardiologi, elettrofisiologi e medici di base specializzati in cardiologia. I rappresentanti di vendita saranno assunti intorno al momento dell'approvazione della FDA.
Inoltre, Milestone prevede di avviare un studio di Fase 3 per etripamil in pazienti con fibrillazione atriale con frequenza ventricolare rapida (AFib-RVR) nel primo semestre del 2025. Lo studio valuterà un regime di dosaggio autoadministrato e ripetuto di 70 mg/dose, mirando a circa 150 eventi in pazienti con episodi sintomatici.
Milestone Pharmaceuticals (MIST) ha delineado sus prioridades estratégicas para 2025, destacando la próxima fecha PDUFA del 27 de marzo de 2025 para el aerosol nasal CARDAMYST™ (etripamil) para la Taquicardia Supraventricular Paroxística (PSVT). La empresa se está preparando para un lanzamiento comercial a mediados de 2025, a la espera de la aprobación de la FDA.
La empresa ha fortalecido su equipo de liderazgo de lanzamiento con Jeff Moore como VP de Ventas y planea desplegar aproximadamente 60 profesionales de ventas centrados en cardiólogos, electrofisiólogos y médicos de atención primaria enfocados en cardiología. Se contratarán representantes de ventas alrededor del momento de la aprobación de la FDA.
Además, Milestone planea iniciar un ensayo de Fase 3 para etripamil en pacientes con fibrilación auricular con frecuencia ventricular rápida (AFib-RVR) en el primer semestre de 2025. El estudio evaluará un régimen de dosis autoadministrado y repetido de 70 mg/dosis, con un objetivo de aproximadamente 150 eventos en pacientes con episodios sintomáticos.
Milestone Pharmaceuticals (MIST)는 2025년 전략 우선 사항을 개략적으로 설명하며, 2025년 3월 27일에 예정된 CARDAMYST™ (etripamil) 비강 스프레이의 PDUFA 날짜를 강조했습니다. 이 회사는 FDA의 승인을 기다리며 2025년 중반에 상업적 출시를 준비하고 있습니다.
회사는 Jeff Moore를 영업 부사장으로 임명하여 출시 리더십 팀을 강화했으며, 심장 전문의, 전기생리학자 및 심장 전문 1차 진료 의사에 중점을 두고 약 60명의 영업 전문가를 배치할 계획입니다. 영업대표는 FDA 승인 시점에 맞춰 채용될 예정입니다.
또한 Milestone은 2025년 상반기 중 심박수 급속한 심방세동 환자를 대상으로 etripamil의 3상 시험을 시작할 계획입니다. 이 연구는 증상이 있는 에피소드를 겪는 환자에서 70mg/용량의 자가 투여, 반복 투여 요법을 평가할 예정이며, 약 150건의 사건을 목표로 하고 있습니다.
Milestone Pharmaceuticals (MIST) a défini ses priorités stratégiques pour 2025, soulignant la prochaine date PDUFA du 27 mars 2025 pour le spray nasal CARDAMYST™ (etripamil) destiné à la Tachycardie Supraventriculaire Paroxystique (PSVT). L'entreprise se prépare à un lancement commercial au milieu de 2025, en attendant l'approbation de la FDA.
L'entreprise a renforcé son équipe de direction pour le lancement avec Jeff Moore comme VP des Ventes et prévoit de déployer environ 60 professionnels des ventes ciblant les cardiologues, les électrophysiologistes et les médecins de soins primaires spécialisés en cardiologie. Les représentants commerciaux seront embauchés autour de la période d'approbation de la FDA.
De plus, Milestone prévoit de lancer un essai de Phase 3 pour l'etripamil chez des patients souffrant de fibrillation auriculaire avec une fréquence ventriculaire rapide (AFib-RVR) au premier semestre 2025. L'étude évaluera un schéma posologique autoadministré et répété de 70 mg/dose, visant environ 150 événements chez des patients présentant des épisodes symptomatiques.
Milestone Pharmaceuticals (MIST) hat seine strategischen Prioritäten für 2025 umrissen und hebt das bevorstehende PDUFA-Datum von 27. März 2025 für das Nasenspray CARDAMYST™ (etripamil) zur Behandlung der paroxysmalen supraventrikulären Tachykardie (PSVT) hervor. Das Unternehmen bereitet sich auf eine kommerzielle Markteinführung Mitte 2025 vor, abhängig von der Genehmigung durch die FDA.
Das Unternehmen hat sein Launch-Führungsteam gestärkt, indem Jeff Moore als VP für Vertrieb eingestellt wurde, und plant, etwa 60 Vertriebsmitarbeiter zu rekrutieren, die sich auf Kardiologen, Elektrophysiologen und kardiologisch ausgerichtete Hausärzte konzentrieren. Vertriebsmitarbeiter sollen rund um den Zeitpunkt der FDA-Genehmigung eingestellt werden.
Zusätzlich plant Milestone, im ersten Halbjahr 2025 eine Phase-3-Studie für Etripamil bei Patienten mit Vorhofflimmern und schneller ventrikulärer Rate (AFib-RVR) zu starten. Die Studie wird ein selbstverabreichtes, wiederholtes Dosierungsschema von 70 mg/Dosis bewerten, das sich auf etwa 150 Ereignisse bei Patienten mit symptomatischen Episoden konzentriert.
- FDA PDUFA date set for March 27, 2025 for CARDAMYST
- FDA has indicated no advisory committee is planned
- Commercial launch team expansion with key VP of Sales hire
- Planned deployment of 60-person sales force
- None.
Insights
The upcoming PDUFA date for CARDAMYST represents a pivotal moment for Milestone Pharmaceuticals, with several positive indicators suggesting strong potential for approval. The FDA's decision not to convene an advisory committee is particularly noteworthy, as it often indicates a straightforward review process and confidence in the application's data package.
The commercial strategy appears well-structured, with a targeted initial sales force of 60 professionals - a size that suggests careful market analysis and cost-efficient deployment. The focus on clinical cardiologists, electrophysiologists and cardiac-focused primary care physicians demonstrates a precise understanding of the prescriber landscape for PSVT management.
The planned Phase 3 study in AFib-RVR represents a strategic expansion of CARDAMYST's potential market. The trial design, incorporating FDA feedback and targeting 150 events with the same successful dosing regimen from the RAPID trial, indicates a de-risked approach to indication expansion. This could significantly expand the addressable market, as AFib-RVR represents a larger patient population than PSVT.
The timing of the planned commercial presence at major cardiology conferences (ACC.2025 and HRS) immediately following the PDUFA date shows excellent strategic planning, potentially maximizing early adoption among key opinion leaders. This coordinated approach to medical education and commercial launch suggests a well-thought-out market entry strategy.
- PDUFA date of March 27, 2025 for CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT)
- Commercial capabilities build out in process, with proposed launch in PSVT targeted for mid-2025
- Plans to initiate Phase 3 Study in AFib-RVR in H1 2025
MONTREAL and CHARLOTTE, N.C., Jan. 28, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today provided a corporate update and outlined its strategic priorities for 2025.
“2025 is set to be a transformative year for Milestone as we prepare for potential FDA approval of CARDAMYST and the opportunity to empower patients suffering with PSVT to self-manage episodes outside of the healthcare setting,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “Our leadership team is building a solid foundation for the planned launch of CARDAMYST mid-year, and we look forward to sharing a comprehensive update at our investor event on February 25.”
CARDAMYST for Paroxysmal Supraventricular Tachycardia
- FDA Prescription Drug User Fee Act (PDUFA) target date is March 27, 2025. Milestone’s New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, its lead investigational product, for the management of PSVT, is under review at the U.S. Food and Drug Administration (FDA). The FDA has communicated that an advisory committee is not planned.
- Launch in PSVT targeted for mid-2025. Milestone is currently preparing for a commercial launch of CARDAMYST in mid-2025 pending FDA approval. The launch leadership team has been strengthened by the recent hiring of Jeff Moore as VP of Sales, adding to already established expertise in Marketing, Medical Affairs, and Market Access. Regional sales management is expected to be on board in February to lead a launch sales team of approximately 60 professionals initially focused on clinical cardiologists, electrophysiologists, and cardiac-focused primary care physicians. Sales representatives will be hired around the time of FDA approval and will be added to our current field based Medical Affairs and Market Access Teams engaged with regional and national Key Opinion Leaders, Patient Advocacy Organizations and Payer Organizations.
Investor Event in New York, February 25
- The company will host a live investor event to provide an overview of its commercial strategy for CARDAMYST. The event will feature presentations by Joseph Oliveto, President and CEO, and Lorenz Muller, Chief Commercial Officer. To register, click here or contact Sam Matel at smatel@lifesciadvisors.com.
- Upcoming Medical Conferences. Assuming approval on the PDUFA date, Milestone will have its first branded product presence at ACC.2025 (American College of Cardiology annual meeting, March 29 to 31, 2025 in Chicago) and the Heart Rhythm Society Annual Meeting (April 24 to 27, 2025 in San Diego).
Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR)
- Phase 3 pivotal trial in AFib-RVR expected to begin enrollment in H1 2025. Milestone plans to initiate a trial of etripamil nasal spray in patients with AFib-RVR in the at-home setting. The protocol has been finalized, incorporating FDA feedback, and the study is sized based on achieving approximately 150 events in patients with symptomatic episodes. A self-administered, repeat-dose regimen of 70 mg/dose will be evaluated (the same approach that was studied in the successful RAPID trial in PSVT).
About Etripamil
Etripamil is Milestone's lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, 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. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone's lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR.
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 timing and outcomes of future interactions with the FDA, including the PDUFA target date; the timing and enrollment of our Phase 3 trial in AFib-RVR; the timing of our potential commercial launch of CARDAMYST; the timing of our first branded product presence; the potential of etripamil to provide health care providers with a new treatment option to enable on-demand care and patient self-management and provide patients with active management and a greater sense of control over their condition. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our 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, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza 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, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption "Risk Factors," as such discussion may be updated from time to time by subsequent filings Milestone may make with the U.S. Securities & Exchange Commission. 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:
Kim Fox, Vice President, Communications, kfox@milestonepharma.com
Investor Relations
Chris Calabrese, ccalabrese@lifesciadvisors.com
Kevin Gardner, kgardner@lifesciadvisors.com
FAQ
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