Earnings summaries and quarterly performance for Milestone Pharmaceuticals.
Executive leadership at Milestone Pharmaceuticals.
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Recent press releases and 8-K filings for MIST.
Milestone Pharmaceuticals announces U.S. availability of CARDAMYST nasal spray
MIST
Product Launch
New Projects/Investments
- Milestone Pharmaceuticals Inc. announced the U.S. availability of CARDAMYST™ (etripamil) nasal spray, which is the first and only FDA-approved self-administered treatment for adults with paroxysmal supraventricular tachycardia (PSVT).
- CARDAMYST is now available through U.S. retail pharmacies.
- A national sales force will be deployed in mid-February 2026 for promotional launch, and the company expects a $25 copay cap for eligible commercially insured patients.
Jan 26, 2026, 2:27 PM
Milestone Pharmaceuticals announces U.S. availability of CARDAMYST
MIST
Product Launch
New Projects/Investments
- Milestone Pharmaceuticals has launched CARDAMYST™ (etripamil) nasal spray, making it available through U.S. retail pharmacies for adults with paroxysmal supraventricular tachycardia (PSVT).
- A national sales force will be deployed in mid-February 2026 to support the promotional launch of CARDAMYST.
- The launch is supported by a patient assistance program, with copays for eligible commercially insured patients expected to be capped at $25.
- CARDAMYST received U.S. Food and Drug Administration (FDA) approval on December 12, 2025, representing the first FDA approval for a PSVT treatment in over 30 years.
Jan 26, 2026, 1:00 PM
Milestone Pharmaceuticals announces EMA acceptance of Marketing Authorization Application for etripamil nasal spray
MIST
Product Launch
New Projects/Investments
- Milestone Pharmaceuticals Inc. announced the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for etripamil nasal spray, a treatment for paroxysmal supraventricular tachycardia (PSVT).
- An EMA decision on the approval of etripamil (conditionally branded as TACHYMIST™ in Europe) is expected by the first quarter of 2027.
- If approved, etripamil would be the first patient self-administered therapy for PSVT in Europe, a market with approximately two million affected individuals.
- The MAA is supported by data from the Pivotal RAPID Phase 3 trial, where 64% of participants using etripamil converted to sinus rhythm within 30 minutes compared to 31% on placebo.
- Etripamil is already FDA approved in the U.S. for PSVT under the brand name CARDAMYST™.
Jan 6, 2026, 1:05 PM
Milestone Pharmaceuticals receives FDA approval for CARDAMYST
MIST
Product Launch
New Projects/Investments
- Milestone Pharmaceuticals Inc. announced on December 12, 2025, that the U.S. Food and Drug Administration (FDA) approved CARDAMYST™ (etripamil) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
- This approval marks Milestone's first commercial product and is the first FDA-approved self-administered treatment in over 30 years for the estimated two million Americans living with PSVT.
- CARDAMYST is expected to be available in retail pharmacies in the first quarter of 2026, and Milestone is well-capitalized for its launch and commercialization with existing capital and royalty financing.
- Clinical data demonstrated that CARDAMYST was two times more likely to convert symptomatic PSVT to sinus rhythm and more than three times faster compared to placebo, with a median conversion time of 17 minutes.
Dec 15, 2025, 1:56 PM
Milestone Pharmaceuticals Announces FDA Approval of CARDAMYST
MIST
Product Launch
- Milestone Pharmaceuticals announced the FDA approval of CARDAMYST nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT), marking the first new therapeutic option in over 30 years for this condition.
- CARDAMYST is designed as a rapid-acting, self-administered treatment for the more than 2 million Americans living with PSVT, with a strong clinical efficacy profile and a clean safety label.
- The wholesale acquisition cost (WAC) for CARDAMYST is set at $1,649 per prescription, with Milestone expecting net revenues of between $500 and $1,000 per prescription.
- Milestone plans to launch CARDAMYST with a 60-person sales force targeting 10,000 key healthcare providers who manage approximately 500,000 PSVT patients annually.
- The company anticipates relatively rapid formulary placement due to no anticipated branded competition and an attractive healthcare resource utilization value proposition, with a 9.5% royalty on sales payable to RTW for the foreseeable future.
Dec 15, 2025, 1:00 PM
MIST Receives FDA Approval for CARDAMYST Nasal Spray
MIST
Product Launch
New Projects/Investments
- The FDA has approved CARDAMYST nasal spray for the treatment of Paroxysmal Supraventricular Tachycardia (PSVT), marking the first new therapeutic option for PSVT in over 30 years for the more than 2 million Americans affected by this condition.
- Milestone has set the wholesale acquisition cost (WAC) for CARDAMYST at $1,649 per prescription, anticipating net revenues of between $500 and $1,000 per prescription.
- Commercialization plans include an initial sales force of 60 representatives targeting 10,000 healthcare providers who manage approximately 500,000 PSVT patients, with retail availability expected in mid-Q1.
- The company will offer a copay mitigation program for commercially insured patients to pay no more than $25, and a 9.5% royalty will be paid to RTW.
Dec 15, 2025, 1:00 PM
Milestone Pharmaceuticals Announces FDA Approval of Cardamyst Nasal Spray
MIST
Product Launch
New Projects/Investments
- Milestone Pharmaceuticals announced FDA approval of Cardamyst nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT), marking the first new therapeutic option in over 30 years for this condition.
- Cardamyst is a rapid-acting, self-administered treatment that patients can use outside a healthcare setting, with a label reflecting a strong safety profile including only 0.4% of patients experiencing hypotension and 0.1% syncope.
- The company estimates a market of over 2 million Americans with PSVT, costing the healthcare system $5 billion annually, and Cardamyst has patent protection extending to 2042 with no anticipated branded competition.
- The Wholesale Acquisition Cost (WAC) for Cardamyst is $1,649 per prescription, with net revenues to Milestone expected to be between $500 and $1,000 per prescription.
- Milestone will deploy 60 sales representatives to target 10,000 key healthcare providers (primarily cardiologists and electrophysiologists) and will offer a pay-no-more-than-$25 program for commercially insured patients to ensure accessibility and affordability.
Dec 15, 2025, 1:00 PM
Milestone Pharmaceuticals Reports Q3 2025 Results and Provides CARDAMYST Regulatory Update
MIST
Earnings
Product Launch
- Milestone Pharmaceuticals Inc. reported no revenue for the third quarter ended September 30, 2025, and a net loss of $11.9 million for the same period.
- As of September 30, 2025, the company held $82.6 million in cash, cash equivalents, and short-term investments.
- A PDUFA target date of December 13, 2025, has been set for CARDAMYST™ (etripamil) Nasal Spray in Paroxysmal Supraventricular Tachycardia (PSVT), with promotional launch plans in place for quick market readiness upon potential FDA approval.
- The company completed a public equity offering providing approximately $48.7 million in net proceeds and amended a Royalty Purchase Agreement in July 2025, expecting a $75 million royalty payment upon FDA approval.
- Commercial expenses increased to $4.6 million for the third quarter of 2025, up from $1.9 million in the prior year period, primarily due to increased pre-launch activities for CARDAMYST.
Nov 12, 2025, 12:16 PM
Milestone Pharmaceuticals Reports Q3 2025 Financial Results and Provides Regulatory Update
MIST
Earnings
Product Launch
New Projects/Investments
- Milestone Pharmaceuticals reported $82.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025.
- The company is awaiting a Prescription Drug User Fee Act (PDUFA) action date of December 13, 2025, for CARDAMYST™ (etripamil) Nasal Spray for PSVT.
- Financing for the CARDAMYST launch includes $48.7 million in net proceeds from a July 2025 equity offering and an anticipated $75 million royalty payment upon FDA approval.
- For the third quarter of 2025, the company reported a net loss of $11.9 million, with commercial expenses increasing to $4.6 million in preparation for the potential CARDAMYST launch.
- The Phase 3 protocol for etripamil in AFib-RVR (ReVeRA-301) has been finalized, positioning etripamil for a potential second indication.
Nov 12, 2025, 12:01 PM
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