Milestone Pharmaceuticals (NASDAQ:MIST) reported early commercial traction for CARDAMYST following its mid-February launch, while advancing a pivotal Phase III study of etripamil in atrial fibrillation with rapid ventricular rate, or AFib-RVR.
Chief Executive Officer Joseph Oliveto said CARDAMYST represents the first FDA-approved self-administered treatment option for patients experiencing attacks of paroxysmal supraventricular tachycardia, or PSVT. The company said physicians, patients and payers are increasingly recognizing the product’s role in managing episodes outside of hospital settings.
Prescription Base and Coverage Expand
- More than 1,200 total CARDAMYST prescriptions were recorded in the second quarter, versus about 300 in the first quarter.
- First-half prescriptions exceeded 1,500.
- More than 1,000 patients received CARDAMYST in the second quarter, compared with nearly 300 in the first quarter.
- More than 1,300 patients received the product during the first half.
Oliveto said the company views the breadth of the prescriber base as an important early launch indicator. In response to an analyst question, he noted that many prescribers have so far been one-time writers, based on the relationship between the number of prescribers and patients. However, he said Milestone has reached roughly half of its approximately 10,000 high-value physician targets and sees room to build both the number of prescribers and the frequency of prescribing.
Chief Commercial Officer Lorenz Muller said the prescriber group includes electrophysiologists, clinical cardiologists, interventional cardiologists, nurse practitioners and other advanced practice providers. He said electrophysiologists have prescribed CARDAMYST earlier and more broadly than the company initially expected, adding that the subspecialty has shown a strong response to increased promotion.
Market access has also improved since the end of the quarter. Coverage stood at about 25% of commercially insured lives at June 30, largely reflecting an earlier Express Scripts win. As of the week before the call, Milestone had secured formulary coverage representing approximately half of commercially insured lives, driven by decisions from UnitedHealthcare and insurers using Express Scripts or Optum Rx pharmacy benefit management services.
Muller said the company remains focused on securing coverage from remaining major pharmacy benefit managers and expanding access through additional health plans affiliated with Express Scripts and Optum Rx.
Commercial Strategy Shifts Toward Deeper Use and Patient Activation
Management said the improved coverage base supports the next phase of the CARDAMYST launch. The company plans to continue identifying new prescribers while increasing promotional frequency among early adopters and practices that are actively treating PSVT.
Oliveto said increased insurance coverage should improve both prescription volume and revenue per prescription over time. During the early launch period, the company used copay assistance and denial-conversion programs to make the product accessible despite limited coverage. Those efforts reduced average selling prices, he said, but the company expects less denial conversion as payer access expands.
The company also said it has begun targeted patient activation efforts, including enhancements to cardamyst.com and digital advertising. Muller said the campaign is not a broad direct-to-consumer television effort. Instead, it will use targeted advertising on social media, search platforms and health-information websites to educate patients, encourage discussions with providers and offer affordability resources for commercially insured patients.
Management said patient awareness efforts were intentionally delayed until commercial coverage reached a level that would provide patients with greater confidence that they could access the drug. The company said its market research indicates that patients who ask their physicians about CARDAMYST have a high likelihood of receiving a prescription.
AFib-RVR Study Begins Registrational Phase
Milestone has activated lead clinical sites for its pivotal ReVeRA-301 Phase III trial evaluating etripamil for AFib-RVR, with first patient enrollment expected shortly. The trial uses the same 70-milligram dose and repeat-dose regimen approved for CARDAMYST in PSVT. Patients will self-administer etripamil or placebo at home in a double-blind setting after experiencing symptoms.
Oliveto said atrial fibrillation affects an estimated more than 10 million people in the U.S., and Milestone estimates that 3 million to 4 million patients may have burdensome symptomatic rapid ventricular rate episodes. The company is pursuing a single-study supplemental new drug application pathway for a potential label expansion.
Management said the program can leverage operational components, clinical sites and experience from the company’s PSVT studies. However, Oliveto identified two key differences: a patient-reported outcome will be pivotal to the AFib-RVR program, and the company will need to limit the impact of patients incorrectly identifying their episodes before self-administering the study drug.
Milestone also said its marketing application with the European Medicines Agency for PSVT remains on track for a decision in the first half of 2027. In China, regulatory engagement is being managed by partner Everest Medicines.
Second-Quarter Financial Results
Milestone reported second-quarter product revenue of $0.6 million, compared with no product revenue in the year-earlier period. First-half product revenue was $0.8 million.
Research and development expense, net of tax credits, was $3.5 million in the second quarter, down from $3.7 million a year earlier. Selling, general and administrative expense increased to $22.6 million from $8.9 million, which the company attributed to personnel, professional and operational expenses associated with the CARDAMYST launch.
Net loss was $28.6 million, or $0.21 per share, compared with a loss of $13 million, or $0.20 per share, in the second quarter of 2025. For the first six months of 2026, net loss was $54.7 million, or $0.41 per share.
Cash, cash equivalents and short-term investments totaled $170.6 million at June 30, compared with $106 million at the end of 2025. Chief Financial Officer Amit Hasija said the company expects its cash resources to fund operating expenses and capital expenditures into the second half of 2027.
About Milestone Pharmaceuticals (NASDAQ:MIST)
Milestone Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on developing innovative therapies for respiratory diseases. The company’s research emphasizes both biologic and small-molecule approaches designed to improve mucociliary clearance, reduce airway inflammation and address chronic and refractory cough. Milestone’s pipeline targets key underserved conditions such as cystic fibrosis, primary ciliary dyskinesia and severe asthma.
Milestone’s lead product candidates are delivered through inhalation or systemic administration, reflecting the company’s commitment to optimizing therapeutic delivery directly to the lungs.
