Milestone Pharmaceuticals Inc.

New Data Presented at AHA Scientific Sessions 2026 Demonstrate That CARDAMYST® (etripamil) Nasal Spray Converted Recurrent PSVT to Normal Heart Rhythm in Patients with Prior Catheter Ablation

New Phase 3 RAPID subgroup data show CARDAMYST (etripamil) nasal spray converted 66.7% of post-ablation PSVT patients to normal sinus rhythm within 30 minutes, versus 20% on placebo. The prior-ablation subgroup was small (N=11) and the analysis was descriptive and not powered for between-group comparison, though responses mirrored the broader RAPID efficacy population. The data, presented at AHA Scientific Sessions 2026, support expanding the drug's use to patients with recurrent PSVT after failed catheter ablation — a supportive commercial signal for the already FDA-approved product.

•7d ago

Milestone Pharmaceuticals Announces First European Study Participant Enrolled in ReVeRA-301 Phase 3 Clinical Trial

Milestone Pharmaceuticals enrolled its first European patient in ReVeRA-301, the ongoing Phase 3 pivotal trial of etripamil nasal spray for atrial fibrillation with rapid ventricular rate (AFib-RVR). The participant was enrolled at a site in the Dutch Cardiovascular Investigator Network (WCN) in the Netherlands, as enrollment advances toward roughly 150 AFib-RVR patient events. U.S. enrollment began in August 2026 and expanded to Canada. The trial uses the same 70 mg repeat-dose regimen FDA-approved for PSVT as CARDAMYST, and Milestone is pursuing a single-study sNDA registration pathway for AFib-RVR with ventricular-rate reduction at 30 minutes as the primary endpoint.

•1mo ago

Milestone Pharmaceuticals Enrolls First Canadian Study Participant in ReVeRA-301 Phase 3 Pivotal Trial Evaluating Etripamil Nasal Spray for AFib-RVR

Milestone Pharmaceuticals enrolled the first Canadian patient in its ReVeRA-301 Phase 3 pivotal trial of etripamil nasal spray for atrial fibrillation with rapid ventricular rate, with the Montreal Heart Institute activated as the first Canadian site. The multinational study targets approximately 150 patient events, using the same 70 mg repeat-dose regimen FDA-approved for PSVT as CARDAMYST, and Milestone is pursuing a single-study sNDA registration pathway for AFib-RVR. Canadian expansion signals enrollment momentum following the first U.S. patient, but trial completion and data remain well in the future; AFib affects an estimated 6 million people in the U.S. and up to 800,000 in Canada.

•1mo ago

Milestone Pharmaceuticals Announces NMPA Approval of Etripamil Nasal Spray for PSVT in China, Marking First Regulatory Approval of Etripamil Outside of the United States

China's NMPA has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia in adults, marking the first regulatory approval of the drug outside the United States. The approval triggers a $2.0 million milestone payment to Milestone from Everest Medicines, its exclusive Greater China licensee, which will lead commercialization in a market with an estimated 3-6 million diagnosed PSVT patients. Milestone remains eligible for up to $98.0 million in additional milestones plus tiered royalties of up to 18% on future China sales. The decision was based on the global Phase 3 RAPID study and the Phase 3 JX02002 study in China, where etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes (hazard ratio 3.002, p=0.0005), with no serious adverse events reported within 24 hours of dosing.

•2mo ago

Everest Medicines Announces China NMPA Approval of CARDAMYST® for the Conversion of Acute Symptomatic Episodes of Paroxysmal Supraventricular Tachycardia (PSVT) to Sinus Rhythm in Adults

China's NMPA has approved CARDAMYST (etripamil) nasal spray for converting acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults, marking Everest Medicines' first approved cardiovascular therapy in China. The approval was supported by the global pivotal Phase III RAPID trial and the China Phase III JX02002 study, both of which met their primary endpoints; in RAPID, 64% of patients who self-administered etripamil converted to sinus rhythm within 30 minutes versus 31% on placebo. Etripamil was developed by Milestone Pharmaceuticals (Nasdaq: MIST), which out-licensed Greater China rights in 2021; Everest acquired those rights from CORXEL in March 2026, so the approval validates MILESTONE's molecule while near-term China economics accrue to Everest. The FDA approved CARDAMYST in December 2025, and the drug is also in Phase III for atrial fibrillation with rapid ventricular response, with Everest citing potential to reach more than 12 million patients in China.

•2mo ago

Milestone Pharmaceuticals Announces Data Presented at ESC Congress 2026 on the Impact of Paroxysmal Supraventricular Tachycardia (PSVT) on Patients’ Daily Lives and Quality of Life Between Episodes

Milestone Pharmaceuticals presented data at the ESC Congress 2026 from a longitudinal study of 247 adults illustrating the significant quality-of-life burden PSVT places on patients between acute episodes. The study found that 73% of patients reported daytime activity interruptions and an average anxiety level of 3.1 on a 7-point scale, with many patients avoiding driving and travel due to the condition. Milestone's lead product CARDAMYST is an FDA-approved nasal spray for the conversion of acute symptomatic PSVT episodes and is currently in Phase 3 development for AFib-RVR.

•2mo ago

Milestone Pharmaceuticals Initiates Pivotal Phase 3 Trial of Etripamil Nasal Spray for Self-Administered Treatment of Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR)

Milestone Pharmaceuticals has enrolled the first patient in the Phase 3 ReVeRA-301 pivotal trial evaluating etripamil nasal spray for atrial fibrillation with rapid ventricular rate (AFib-RVR). The study will utilize the same 70 mg repeat-dose regimen that is FDA-approved for PSVT under the brand name CARDAMYST, targeting a primary endpoint of ventricular rate reduction within 30 minutes. Milestone is pursuing a single-study supplemental new drug application (sNDA) pathway for this indication, aiming to address a substantial unmet medical need for self-administered treatment.

•2mo ago

Milestone Pharmaceuticals Announces Second Quarter 2026 Financial Results and Provides Corporate Update

CARDAMYST's commercial launch accelerated significantly in Q2, with insurance coverage rising to over 50% of commercially insured lives and total prescription fills growing to more than 1,500. Financial results showed $0.6 million in product revenue for the quarter and a cash balance of $170.6 million, which the company expects to fund operations into the second half of 2027. Operationally, the Phase 3 ReVeRA-301 trial for etripamil in AFib-RVR is now open and enrolling patients, while regulatory reviews for PSVT indications remain on track in Europe and China.

•2mo ago

Milestone Pharmaceuticals Announces First Quarter 2026 Financial Results and Provides Corporate Update

Milestone Pharmaceuticals reported first-quarter 2026 financial results, with $0.2 million in product revenue from the launch of CARDAMYST™ (etripamil) nasal spray for PSVT. The company secured national formulary coverage from Express Scripts, making CARDAMYST more accessible and affordable for commercially insured patients. Approximately 400 unique prescribers have started patients on the drug, and over 25% of commercially insured lives in the U.S. now have coverage. Milestone has initiated a Phase 3 registrational trial for etripamil in patients with AFib-RVR, with patient enrollment expected to begin in the second half of 2026. The company also presented data on the safety and efficacy of etripamil at several medical conferences. Milestone's strong balance sheet of $184.2 million provides runway into the second half of 2027, covering operating expenses and capital expenditure.

•5mo ago