MILESTONE PHARMACEUTICALS

Q1 2025 anticipates 5 key FDA decisions: AXS-07 for acute migraine, NT-501 for Macular Telangiectasia type 2, Vutrisiran for ATTR-CM, Gepotidacin for uUTIs, and Etripamil Nasal Spray for PSVT, promising advancements in treatment paradigms.

Milestone Pharmaceuticals reported Q3 2024 financials, focusing on potential FDA approval for CARDAMYST nasal spray for PSVT, with a PDUFA date set for March 27, 2025. The company also plans to initiate a Phase 3 trial for etripamil in AFib-RVR in H1 2025. Financial highlights include a net loss of $9.4 million for Q3 2024, with cash, cash equivalents, and short-term investments totaling $76.4 million as of September 30, 2024.

The 'Atrial Fibrillation - Pipeline Insight, 2024' report by ResearchAndMarkets.com provides insights on 12+ companies and 12+ pipeline drugs, including Milvexian (Bristol-Myers Squibb), Etripamil (Milestone Pharmaceuticals), and AP31969 (Acesion Pharma). The report covers clinical and nonclinical stage products, therapeutics assessment, and pipeline development activities.

Milestone Pharmaceuticals announced positive results from Ji Xing Pharmaceuticals' Phase 3 trial of etripamil nasal spray for paroxysmal supraventricular tachycardia (PSVT) in China, meeting primary and secondary endpoints with significant efficacy and safety. The trial aligns with Milestone's RAPID Phase 3 Study. Milestone and Ji Xing have a licensing agreement for etripamil in Greater China, with potential milestone payments and royalties.

Milestone Pharmaceuticals announced the FDA accepted their New Drug Application for Cardamyst (etripamil) nasal spray, intended for paroxysmal supraventricular tachycardia (PSVT) management. The PDUFA target date is set for 10 months after the acceptance date. Cardamyst aims to provide a new, convenient treatment option for PSVT patients, potentially allowing self-management without medical supervision.

Milestone Pharmaceuticals resubmits NDA for etripamil, a calcium channel blocker nasal spray for treating PSVT, addressing FDA concerns. If approved, etripamil could offer a self-administered treatment option for PSVT and AFib-RVR, potentially impacting millions of patients in the U.S.