Milestone Pharmaceuticals Awaits FDA Decision on CARDAMYST Nasal Spray

Milestone Pharmaceuticals (MIST) awaits FDA decision on CARDAMYST nasal spray for paroxysmal supraventricular tachycardia treatment. The FDA has set a decision date of December 13 under the Prescription Drug User Fee Act. The company has extended a $75 million purchase and sale agreement with RTW Investments and submitted additional study results to comply with FDA guidelines. Analysts forecast an average target price of $3.33 with an upside of 30.21% from the current price of $2.56.

Milestone Pharmaceuticals Inc. (MIST) is eagerly awaiting the FDA's decision on its investigational therapy, CARDAMYST™ (etripamil) nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). The U.S. Food and Drug Administration (FDA) has assigned a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025, marking a significant milestone in the drug's regulatory journey [1].

Concurrent with the FDA's acceptance of Milestone's response to the Complete Response Letter (CRL), the company has extended its $75 million purchase and sale agreement (Royalty Purchase Agreement) with RTW Investments, LP and certain of its affiliates (RTW) until December 31, 2025. The proceeds from this agreement are expected to support the successful launch of CARDAMYST following FDA approval and satisfaction of other customary closing conditions [2].

In March 2025, Milestone received a CRL from the FDA, prompting the company to conduct additional in-vitro studies and transfer the duties of a manufacturing testing facility to other contracted vendors with a recent inspection history with the FDA. The FDA has not raised any concerns regarding the clinical section of the NDA. CARDAMYST, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT [1].

Analysts forecast an average target price of $3.33 with an upside of 30.21% from the current price of $2.56 for MIST, reflecting investor sentiment on the potential success of CARDAMYST's FDA approval [2].

References:
[1] https://finance.yahoo.com/news/milestone-pharmaceuticals-announces-fda-acceptance-100000288.html
[2] https://www.marketscreener.com/quote/stock/MILESTONE-PHARMACEUTICALS-58002404/news/Milestone-Pharmaceuticals-Inc-Announces-FDA-Acceptance-of-the-Company-s-Response-to-the-CRL-for-CAR-50490073/