Milestone Pharmaceuticals to Host Commercial Launch Plan Investor Event in New York on February 25, 2025
Milestone Pharmaceuticals (Nasdaq: MIST) has announced details for its upcoming Commercial Launch Plan investor event, scheduled for February 25, 2025, in New York. The event, running from 10:30 AM to 12:30 PM ET, will be available both in-person and virtually.
The presentation will feature Joseph Oliveto, President and CEO, and Lorenz Muller, Chief Commercial Officer, who will outline the commercial strategy for etripamil nasal spray (proposed trade name CARDAMYST™). This lead investigational product is designed for managing paroxysmal supraventricular tachycardia (PSVT).
The company's New Drug Application (NDA) for CARDAMYST is currently under FDA review, with a PDUFA target date of March 27, 2025. Milestone anticipates a mid-2025 launch for PSVT treatment. The event will conclude with a live Q&A session.
Milestone Pharmaceuticals (Nasdaq: MIST) ha annunciato i dettagli del suo prossimo evento per gli investitori sul Piano di Lancio Commerciale, programmato per il 25 febbraio 2025 a New York. L'evento, che si terrà dalle 10:30 alle 12:30 ET, sarà disponibile sia di persona che virtualmente.
La presentazione vedrà la partecipazione di Joseph Oliveto, Presidente e CEO, e di Lorenz Muller, Direttore Commerciale, che delineeranno la strategia commerciale per etripamil spray nasale (nome commerciale proposto CARDAMYST™). Questo prodotto investigativo principale è progettato per gestire la tachicardia sopraventricolare parossistica (PSVT).
La richiesta di Nuovo Farmaco (NDA) dell'azienda per CARDAMYST è attualmente in fase di revisione da parte della FDA, con una data obiettivo PDUFA fissata per il 27 marzo 2025. Milestone prevede un lancio a metà 2025 per il trattamento della PSVT. L'evento si concluderà con una sessione di domande e risposte dal vivo.
Milestone Pharmaceuticals (Nasdaq: MIST) ha anunciado los detalles de su próximo evento para inversores sobre el Plan de Lanzamiento Comercial, programado para el 25 de febrero de 2025 en Nueva York. El evento, que se llevará a cabo de 10:30 a 12:30 PM ET, estará disponible tanto de manera presencial como virtual.
La presentación contará con Joseph Oliveto, Presidente y CEO, y Lorenz Muller, Director Comercial, quienes describirán la estrategia comercial para etripamil aerosol nasal (nombre comercial propuesto CARDAMYST™). Este producto investigacional líder está diseñado para el manejo de la taquicardia supraventricular paroxística (PSVT).
La Solicitud de Nuevo Medicamento (NDA) de la compañía para CARDAMYST está actualmente bajo revisión de la FDA, con una fecha objetivo PDUFA del 27 de marzo de 2025. Milestone anticipa un lanzamiento a mediados de 2025 para el tratamiento de la PSVT. El evento concluirá con una sesión de preguntas y respuestas en vivo.
Milestone Pharmaceuticals (Nasdaq: MIST)는 2025년 2월 25일 뉴욕에서 예정된 상업 출시 계획 투자자 이벤트의 세부 사항을 발표했습니다. 이 행사는 ET 기준으로 오전 10시 30분부터 오후 12시 30분까지 진행되며, 현장 참석과 가상 참석 모두 가능합니다.
발표에는 Joseph Oliveto 사장 및 CEO와 Lorenz Muller 상업 담당이사가 참여하여 etripamil 비강 스프레이 (제안된 상표명 CARDAMYST™)의 상업적 전략을 설명할 것입니다. 이 주요 연구 제품은 발작성 상심실 빈맥(PSVT) 관리를 위해 설계되었습니다.
회사의 CARDAMYST에 대한 신약 신청(NDA)은 현재 FDA 검토 중이며, PDUFA 목표일은 2025년 3월 27일입니다. Milestone은 PSVT 치료를 위한 2025년 중반 출시를 예상하고 있습니다. 행사 마지막에는 라이브 Q&A 세션이 진행될 예정입니다.
Milestone Pharmaceuticals (Nasdaq: MIST) a annoncé les détails de son prochain événement pour investisseurs concernant le Plan de Lancement Commercial, prévu pour le 25 février 2025 à New York. L'événement, qui se déroulera de 10h30 à 12h30 ET, sera disponible à la fois en présentiel et virtuellement.
La présentation mettra en vedette Joseph Oliveto, Président et CEO, et Lorenz Muller, Directeur Commercial, qui exposeront la stratégie commerciale pour etripamil spray nasal (nom commercial proposé CARDAMYST™). Ce produit d'investigation principal est conçu pour gérer la tachycardie supraventriculaire paroxystique (PSVT).
La Demande de Nouveau Médicament (NDA) de l'entreprise pour CARDAMYST est actuellement sous examen par la FDA, avec une date cible PDUFA fixée au 27 mars 2025. Milestone prévoit un lancement à mi-2025 pour le traitement de la PSVT. L'événement se terminera par une séance de questions-réponses en direct.
Milestone Pharmaceuticals (Nasdaq: MIST) hat die Einzelheiten zu seiner bevorstehenden Investorenveranstaltung zum kommerziellen Launch-Plan bekannt gegeben, die für den 25. Februar 2025 in New York angesetzt ist. Die Veranstaltung findet von 10:30 bis 12:30 Uhr ET statt und wird sowohl persönlich als auch virtuell angeboten.
Die Präsentation wird Joseph Oliveto, Präsident und CEO, sowie Lorenz Muller, Chief Commercial Officer, umfassen, die die kommerzielle Strategie für etripamil Nasenspray (vorgeschlagener Handelsname CARDAMYST™) skizzieren werden. Dieses führende Forschungsprodukt ist zur Behandlung von paroxysmaler supraventrikularer Tachykardie (PSVT) konzipiert.
Der Neue Arzneimittelantrag (NDA) des Unternehmens für CARDAMYST befindet sich derzeit in der Überprüfung durch die FDA, mit einem PDUFA-Zieltermin am 27. März 2025. Milestone erwartet einen Launch zur Mitte 2025 für die PSVT-Behandlung. Die Veranstaltung wird mit einer Live-Q&A-Session enden.
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MONTREAL and CHARLOTTE, N.C., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced further details on its in-person and virtual Commercial Launch Plan investor event to take place in New York on Tuesday, February 25, 2025 from 10:30 AM to 12:30 PM ET. Investors planning to attend the in-person event are required to register in advance. To register, click here.
Featuring presentations by Joseph Oliveto, President and Chief Executive Officer, and Lorenz Muller, Chief Commercial Officer, the event will provide an overview of Milestone’s commercial strategy for etripamil nasal spray (proposed trade name CARDAMYST™), its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). Milestone’s New Drug Application (NDA) for CARDAMYST is currently under review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025. Milestone currently expects to launch in PSVT mid-2025.
A live question and answer session will follow the formal presentation.
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 atrial fibrillation with rapid ventricular rate (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 of our potential commercial launch of CARDAMYST; and the ability of etripamil for PSVT to 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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