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Milestone announces FDA acceptance of response to CARDAMYST CRL

Milestone Pharmaceuticals (MIST) announced that the U.S. Food and Drug Administration has accepted for review Milestone’s response to issues raised in the Complete Response Letter for CARDAMYST nasal spray, an investigational, novel therapy for the treatment of patients with paroxysmal supraventricular tachycardia. The FDA has assigned a new Prescription Drug User Fee Act target action date of December 13. Concurrent with the FDA acceptance, Milestone is also announcing today the extension of its $75M purchase and sale agreement with existing shareholder, RTW Investments and certain of its affiliates until December 31. The proceeds from the Royalty Purchase Agreement are expected to aid a planned launch of CARDAMYST in PSVT following expected FDA approval and satisfaction of other customary closing conditions. In March 2023, Milestone entered into the Royalty Purchase Agreement with RTW, pursuant to which RTW agreed to purchase, following the FDA approval of etripamil on or prior to September 30, the right to receive a tiered royalty payments on the annual net product sales of etripamil in the United States, in exchange for a purchase price of $75M. On July 10, Milestone has amended its Royalty Purchase Agreement to provide for a three-month extension of the Approval Date. Pursuant to the Amendment, in order to receive the $75M purchase price, Milestone must receive marketing approval of etripamil from the FDA on or prior to December 31, satisfy the other customary closing conditions. This represents a contingent future source of funding for Milestone. Milestone received a Complete Response Letter from the FDA in March. A Type A meeting was held with the Agency in early June to clarify the outstanding items and reach alignment with the FDA on the requirements for the Company’s response to the CRL. Informed by the FDA meeting, Milestone submitted the response to the CRL on June 13. Included in that response were the results of additional in-vitro studies conducted to meet the updated FDA guidance on nitrosamines, which had been updated since the original NDA submission. Further, in response to the FDA’s need to conduct a pre-approval inspection of a manufacturing testing facility, Milestone transferred the duties of that facility to other contracted vendors that have a relatively recent inspection history with FDA. The FDA has not raised any concerns regarding the clinical section of the NDA.

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