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MONTREAL/CHARLOTTE - The U.S. Food and Drug Administration has accepted Milestone Pharmaceuticals Inc.’s (NASDAQ:MIST) response to a Complete Response Letter for CARDAMYST (etripamil) nasal spray, setting a new target action date of December 13, 2025. The company’s stock, currently trading near its 52-week high of $2.75, has shown remarkable momentum with a 70% return over the past year, according to InvestingPro data.
The company also announced an extension of its $75 million royalty purchase agreement with RTW Investments through December 31, 2025. The agreement, originally set to expire on September 30, will provide funding for the commercial launch of CARDAMYST if FDA approval is received. InvestingPro analysis reveals the company maintains a healthy current ratio of 4.67, indicating strong ability to meet short-term obligations despite operating with moderate debt levels.
CARDAMYST is being developed as a self-administered treatment for paroxysmal supraventricular tachycardia (PSVT), a condition characterized by episodes of abnormally fast heart rate.
Milestone received the Complete Response Letter in March 2025 and held a Type A meeting with the FDA in early June to clarify requirements. The company submitted its response on June 13, which included results from additional in-vitro studies conducted to meet updated FDA guidance on nitrosamines.
The response also addressed the FDA’s need for a pre-approval inspection by transferring manufacturing testing duties to vendors with more recent FDA inspection history. According to the press release, the FDA has not raised concerns regarding the clinical section of the New Drug Application.
"The FDA’s acceptance for review of our response to the CRL is a key milestone for CARDAMYST and we look forward to working with the Agency toward a potential approval decision later this year," said Joe Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals, in a statement.
If approved, CARDAMYST would be designed to allow patients to treat PSVT episodes without immediate medical supervision. With a market capitalization of approximately $170 million and analysts setting price targets ranging from $1 to $5, investors can access 12 additional exclusive InvestingPro Tips and comprehensive financial analysis through an InvestingPro subscription.
In other recent news, Milestone Pharmaceuticals has initiated a public offering of common shares and warrants aimed at raising funds for its lead drug candidate, etripamil. The company plans to use the proceeds for the clinical development and commercial launch of etripamil, targeting paroxysmal supraventricular tachycardia (PSVT). This offering is being managed by TD Cowen, Piper Sandler & Co., and Wells Fargo Securities, with H.C. Wainwright & Co. as the lead manager. Milestone has also resubmitted its filing for the Cardamyst nasal spray for PSVT after addressing Chemistry, Manufacturing, and Controls issues pointed out by the FDA. The resubmission follows a Type A meeting with the FDA, where no efficacy or safety concerns were raised. H.C. Wainwright has maintained its buy rating on Milestone, with a price target of $5.00, citing the potential of Cardamyst to achieve peak sales exceeding $700 million if approved. Additionally, Milestone has submitted a response to the FDA’s Complete Response Letter concerning its New Drug Application for CARDAMYST, with a decision expected within the next thirty days. The company is hopeful for a new Prescription Drug User Fee Act (PDUFA) date later this year, pending regulatory review.
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