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Milestone Pharmaceuticals Announces FDA Acceptance of the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray
New PDUFA Action Date of December 13, 2025 $75 Million Royalty Purchase Agreement Payment from RTW Extended Through 2025 MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) (Milestone) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) nasal spray, an investigational, novel therapy for the treatment
About this update from Milestone Pharmaceuticals Inc.
[{"type":"image","alt":"Milestone Pharmaceuticals Inc.","displaySize":"","headline":null,"caption":"Milestone Pharmaceuticals Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":57,"url":"https://media.zenfs.com/en/globenewswire.com/a3e01b195c1ef10ed327d66d987e808c"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/YgaHOGiuZH1uIXCqN0ZsAw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTgwO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/a3e01b195c1ef10ed327d66d987e808c","width":300,"height":57}},"lazy":false},{"type":"text","content":"New PDUFA Action Date of December 13, 2025","length":42,"tagName":"p"},{"type":"text","content":"$75 Million Royalty Purchase Agreement Payment from RTW Extended Through 2025","length":82,"tagName":"p"},{"type":"text","content":"MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) (Milestone) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) nasal spray, an investigational, novel therapy for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT). The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025.","length":556,"tagName":"p"},{"type":"text","content":"Concurrent with the FDA acceptance, Milestone is also announcing today the extension of its $75.0 million purchase and sale agreement (Royalty Purchase Agreement) with existing shareholder, RTW Investments, LP and certain of its affiliates (RTW) until December 31, 2025. The proceeds from the Royalty Purchase Agreement are expected to aid a successful planned launch of CARDAMYST in PSVT following expected FDA approval and satisfaction of other customary closing conditions.","length":486,"tagName":"p"},{"type":"text","content":"“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. “We are also pleased to amend our Royalty Purchase Agreement with RTW, underscoring their ongoing commitment to Milestone. The anticipat...