Milestone Pharmaceuticals plans an investor event to discuss its etripamil nasal spray's commercial strategy ahead of FDA review.
Quiver AI Summary
Milestone Pharmaceuticals Inc. announced an investor event on February 25, 2025, in New York to discuss its commercial launch plan for etripamil nasal spray, also known as CARDAMYST™, which is under FDA review for the treatment of paroxysmal supraventricular tachycardia (PSVT). The event will feature presentations by the company's CEO and CCO, followed by a Q&A session. Milestone anticipates launching the product in mid-2025, pending FDA approval, which has a target decision date of March 27, 2025. Etripamil is designed as a self-administered rapid response therapy for patients to manage their symptoms without needing immediate medical supervision, potentially offering greater control over their treatment.
Potential Positives
- Milestone Pharmaceuticals announced a Commercial Launch Plan investor event, indicating proactive engagement with investors and transparency about its upcoming strategies.
- The event will detail the commercial strategy for etripamil nasal spray (proposed trade name CARDAMYST™), showcasing the company's focus on innovation in its product offerings for managing paroxysmal supraventricular tachycardia (PSVT).
- The New Drug Application (NDA) for CARDAMYST is currently under review by the FDA, with a target action date of March 27, 2025, suggesting the company's advancements towards regulatory approval and market entry.
- Etripamil is designed as a self-administered therapy, which could provide patients with greater control over their condition, enhancing patient experience and potentially leading to improved health outcomes.
Potential Negatives
- The press release includes a significant number of forward-looking statements that emphasize the risks and uncertainties associated with the FDA review process and the timing of the potential launch of etripamil, indicating that outcomes may not meet investor expectations.
- Milestone Pharmaceuticals highlights potential market risks related to economic conditions, geopolitical events, and public health emergencies, which could impact the company's ability to successfully launch its product and perform financially.
- There is a lack of concrete assurances regarding the approval of the New Drug Application (NDA) for etripamil, making it uncertain whether the anticipated launch will occur as planned.
FAQ
When is Milestone Pharmaceuticals' Commercial Launch Plan investor event?
The event will take place on February 25, 2025, from 10:30 AM to 12:30 PM ET in New York.
How can I register for the Milestone investor event?
Investors must register in advance to attend the in-person event. Registration details are available in the press release.
What is CARDAMYST™ and its purpose?
CARDAMYST™ is the proposed trade name for etripamil, a nasal spray designed for managing paroxysmal supraventricular tachycardia (PSVT).
What are the clinical applications of etripamil?
Etripamil is being developed for self-administration to treat symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular rate.
What is the FDA's role in Milestone's product development?
The FDA is currently reviewing Milestone's New Drug Application (NDA) for CARDAMYST™, with a target date of March 27, 2025.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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
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