Milestone Pharmaceuticals reports financial results for Q1 2025, addressing FDA concerns and obtaining patent.
From GlobeNewswire: 2025-05-14 07:04:00
Milestone Pharmaceuticals Inc. reported financial results for Q1 2025 and submitted a meeting request to the FDA to address Chemistry, Manufacturing, and Controls (CMC) issues raised in a Complete Response Letter (CRL) for CARDAMYST, a treatment for PSVT. No clinical safety or efficacy concerns were raised by the FDA.
The FDA highlighted two key CMC issues in the CRL: additional information on nitrosamine impurities and an inspection of a facility listed in the NDA. A new Method of Use patent for etripamil nasal spray was issued, potentially extending intellectual property protection until July 2042. CARDAMYST was featured in an independent survey of Managed Care professionals.
Cash, cash equivalents, and short-term investments for Milestone Pharmaceuticals Inc. were $56.0 million as of March 31, 2025. The company had no revenue for Q1 2025. Research and development expenses were $5.0 million, general and administrative expenses were $5.2 million, and commercial expenses were $10.4 million. The net loss for Q1 2025 was $20.8 million.
Etripamil is a novel calcium channel blocker nasal spray being studied for PSVT and AFib-RVR. Milestone Pharmaceuticals aims to provide patients with active management and a greater sense of control over their condition. The company’s lead investigational product, etripamil, is designed for patients to self-administer without medical supervision.
Forward-looking statements in the press release include outcomes of interactions with the FDA, addressing CRL issues, the potential NDA resubmission, and CARDAMYST’s potential as a novel treatment option. Milestone Pharmaceuticals Inc. is focused on developing cardiovascular solutions to improve the lives of people with heart conditions.
For further details on the financials and statements, refer to the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC. Contact Kim Fox at [email protected] for more information. Investor Relations can be reached at [email protected].
Read more at GlobeNewswire:: Milestone Pharmaceuticals Reports First Quarter 2025