Milestone Pharmaceuticals' Cardamyst NDA Resubmission Supports Buy Rating Amid FDA Progress

Milestone Pharmaceuticals has resubmitted its NDA for Cardamyst, a treatment for paroxysmal supraventricular tachycardia, which has been accepted by the FDA. Brandon Folkes from H.C. Wainwright maintains a Buy rating and a $5.00 price target due to the company's progress addressing FDA concerns and the potential for approval. Folkes believes the stock presents a favorable risk-reward opportunity.

Milestone Pharmaceuticals Inc. (MIST) has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's response to the Complete Response Letter (CRL) for Cardamyst (etripamil) nasal spray, a novel therapy for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT). The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025 [1].

Cardamyst is a self-administered calcium channel blocker nasal spray designed for rapid response therapy in patients with PSVT and atrial fibrillation with rapid ventricular response (AFib-RVR). The original New Drug Application (NDA) submission faced Chemistry, Manufacturing, and Controls (CMC) issues, prompting additional studies and manufacturing adjustments by Milestone [2].

Milestone's response to the CRL included in-vitro studies on nitrosamines and changes in manufacturing testing facilities to meet FDA guidelines. The FDA has not raised any concerns regarding the clinical section of the NDA [1]. The company also announced an extension of its purchase and sale agreement (Royalty Purchase Agreement) with existing shareholder RTW Investments, LP, and some affiliates until December 31, 2025, to support the planned launch of Cardamyst following FDA approval [2].

Brandon Folkes from H.C. Wainwright maintains a Buy rating and a $5.00 price target for Milestone Pharmaceuticals' stock, citing the company's progress in addressing FDA concerns and the potential for approval [3]. Folkes believes the stock presents a favorable risk-reward opportunity.

References:
[1] https://www.hcplive.com/view/fda-accepts-response-to-crl-for-etripamil-cardamyst-for-treating-psvt
[2] https://www.marketscreener.com/quote/stock/MILESTONE-PHARMACEUTICALS-58002404/news/Milestone-Pharmaceuticals-Announces-FDA-Acceptance-of-the-Company-s-Response-to-the-CRL-for-CARDAM-50488985/
[3] https://www.hcplive.com/view/fda-accepts-response-to-crl-for-etripamil-cardamyst-for-treating-psvt