Milestone Pharmaceuticals submits response to FDA for PSVT drug

MONTREAL/CHARLOTTE - Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a $109.52 million market cap biotech company trading at $1.65 per share, has submitted its response to the U.S. Food and Drug Administration’s Complete Response Letter regarding its New Drug Application for CARDAMYST (etripamil) nasal spray, the company announced Monday. InvestingPro analysis indicates the company is quickly burning through cash, though it maintains a healthy current ratio of 4.67.

The submission follows a Type A meeting with the FDA regarding the drug, which is being developed for the conversion of acute episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults. Analyst targets for the stock range from $1 to $5, reflecting mixed sentiment about the company’s prospects. Get more detailed insights and analysis with InvestingPro, which offers additional exclusive tips about MIST’s financial health.

According to the company, the FDA will determine the acceptance of the response and corresponding PDUFA date within the next thirty days. The review time is expected to be either two or six months from resubmission, depending on the classification. With the company’s overall financial health rated as FAIR by InvestingPro, investors are closely monitoring its progress toward potential commercialization.

"Our recent Type A meeting with the FDA was productive and we believe it provided the guidance necessary to submit our response to the CRL directly after the meeting," said Joe Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals, in the press release.

Etripamil is designed as a self-administered calcium channel blocker nasal spray for patients experiencing PSVT episodes, potentially eliminating the need for immediate medical oversight. The drug has completed a Phase 3 clinical program for PSVT treatment and a Phase 2 trial for patients with atrial fibrillation with rapid ventricular rate.

If approved, CARDAMYST would be the first self-administered therapy for rapid termination of PSVT episodes, according to the company.

The FDA’s decision timeline suggests a potential new PDUFA date later this year, though approval remains subject to regulatory review.

In other recent news, Milestone Pharmaceuticals received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning its New Drug Application (NDA) for etripamil, a nasal spray designed to treat paroxysmal supraventricular tachycardia (PSVT). The FDA’s letter cited issues related to Chemistry, Manufacturing, and Controls (CMC), specifically requiring additional information on nitrosamine impurities and a facility inspection. Following this regulatory setback, TD Cowen downgraded Milestone Pharmaceuticals’ stock rating from Buy to Hold, expressing concerns over the drug’s commercial prospects and the company’s financial constraints.

Milestone Pharmaceuticals reported having $69.7 million in cash, cash equivalents, and short-term investments as of December 31, 2024. The company plans to request a Type A meeting with the FDA to address the issues raised and strategize a path forward for resubmission. In a separate development, Milestone Pharmaceuticals has amended its sales agreement with Jefferies LLC, increasing its common shares offering to $77.8 million. This agreement provides the company with greater financial flexibility to support its operational and development strategies.

Additionally, Milestone Pharmaceuticals announced its 2025 annual meeting of shareholders is scheduled for June 10, 2025, with the record date for determining eligible voters set for April 15, 2025. Shareholders must submit proposals by March 29, 2025, to be considered for inclusion in the proxy materials. These recent developments highlight the challenges and strategic adjustments Milestone Pharmaceuticals is navigating as it works toward resolving regulatory issues and strengthening its financial position.

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