Examining Milestone Pharmaceuticals' Progress Towards FDA Approval
Milestone Pharmaceuticals Updates on Financial Results
Milestone Pharmaceuticals Inc. (NASDAQ: MIST) recently provided a detailed overview of its fourth-quarter and full-year financial outcomes, alongside pivotal updates regarding its regulatory processes and operational strategies. The company is gearing up for the potential FDA approval of CARDAMYST™, a nasal spray designed for the treatment of paroxysmal supraventricular tachycardia (PSVT).
Financial Overview from Q4 2024
As of the end of December 2024, Milestone reported cash, cash equivalents, and short-term investments amounting to $69.7 million. This is a slight increase from $66.0 million recorded a year prior. Importantly, the company has indicated no revenue generation during the fourth quarter or throughout 2024, contrasting with the $1.0 million milestone payment received in 2023 from Corxel Pharmaceuticals.
Research and Development Efforts
For the fourth quarter of 2024, research and development expenses totaled $3.9 million, a significant reduction from the $5.5 million spent in the same period the previous year. Overall, for the full year 2024, total R&D costs were $14.4 million compared to $31.1 million in 2023. This significant decrease reflects the completion of several clinical studies. Meanwhile, general and administrative expenses rose modestly to $4.0 million from $3.4 million year-over-year, with full-year expenses reaching $16.7 million.
Regulatory Updates on CARDAMYST
Milestone is advancing towards obtaining FDA approval for CARDAMYST, its investigational nasal spray for PSVT. As part of this effort, the FDA accepted the New Drug Application (NDA) in May 2024, assigning a Prescription Drug User Fee Act (PDUFA) review goal date of March 27, 2025. If approved, the launch of CARDAMYST is anticipated mid-2025, positioning Milestone to provide a vital new treatment option.
Commercial Strategies and Patents
Milestone has taken proactive steps in preparing for the potential launch, including hosting a Commercial Launch Plan investor event. This event provided insights into their strategies for promoting CARDAMYST, ensuring that healthcare providers and patients have access upon approval. Adding to their positive outlook, Milestone has received a Notice of Allowance for a new method-of-use patent covering the etripamil nasal spray, which could extend intellectual property protection until July 2042.
Etripamil Development for AFib-RVR
In addition to its PSVT focus, Milestone plans to initiate a Phase 3 trial for etripamil in patients with atrial fibrillation rapid ventricular response (AFib-RVR) in 2025. The clinical trial aims to evaluate self-administration of the etripamil nasal spray, which can empower patients by enabling them to manage episodes without immediate medical oversight.
Future Outlook and Investor Relations
Milestone Pharmaceuticals remains firmly positioned to commercialize CARDAMYST, pending FDA approval, supported by a solid financial foundation and a strategic commercialization framework. The management team, led by President and CEO Joseph Oliveto, expressed confidence in their preparations for the launch and in the product’s potential to address the needs of patients suffering from PSVT.
Contact Information
For more details on Milestone's financial performance and future outlook, please reach out to:
Kim Fox
Vice President, Communications
kfox@milestonepharma.com
Kevin Gardner
Investor Relations
kgardner@lifesciadvisors.com
Frequently Asked Questions
What is CARDAMYST?
CARDAMYST is Milestone Pharmaceuticals' investigational nasal spray designed for the treatment of paroxysmal supraventricular tachycardia (PSVT).
What are the financial results for Milestone Pharmaceuticals in Q4 2024?
Milestone reported cash reserves of $69.7 million and no revenue generated during the fourth quarter of 2024.
What is the expected launch date for CARDAMYST?
If FDA approval is granted, CARDAMYST is expected to launch in mid-2025.
How does Milestone plan to commercialize CARDAMYST?
Milestone has devised a strategic commercial launch plan, including investor events to discuss their marketing strategies.
Who can I contact for more information regarding Milestone Pharmaceuticals?
You can reach out to Kim Fox, VP of Communications, or Kevin Gardner for investor-related inquiries through the provided email addresses.
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