Milestone Taps Legal Vet for Landmark Cardiac Drug Launch

MONTREAL and CHARLOTTE, N.C. – February 10, 2026 – Milestone Pharmaceuticals has appointed veteran life sciences attorney David Sandoval as its new General Counsel and Chief Compliance Officer, a strategic move that fortifies its leadership as the company embarks on its most critical endeavor: the commercial launch of CARDAMYST™ (etripamil) nasal spray.

The appointment, announced today, places an experienced legal and compliance leader at the helm just as Milestone transitions from a clinical-stage developer to a full-fledged commercial entity. CARDAMYST, which secured U.S. Food and Drug Administration (FDA) approval on December 12, 2025, is a first-in-class, self-administered therapy for paroxysmal supraventricular tachycardia (PSVT), a sudden and distressing rapid heart rate condition.

“David’s appointment strengthens our leadership team at a critical stage for Milestone as we execute on the launch of CARDAMYST,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “His extensive experience leading legal and compliance teams and supporting commercial launches in highly regulated environments will be invaluable as we scale our operations and build the infrastructure to support long-term growth.”

A Veteran Navigator for Complex Waters

Mr. Sandoval brings a formidable track record to Milestone, with over 15 years of experience steering pharmaceutical companies through the complex legal and regulatory landscapes of late-stage development and first-product commercialization. His career is marked by a history of building compliance frameworks from the ground up and guiding companies through pivotal growth phases.

Before joining Milestone, Sandoval served as Senior Vice President and General Counsel at MaxCyte, Inc., where he was instrumental in major strategic transactions, including an acquisition, and modernized the company's global legal and risk management functions. His tenure at Leadiant Biosciences, Inc. is particularly notable, as he built the U.S. legal and compliance departments from scratch, overseeing multiple product launches across a diverse portfolio of biologics, small molecules, and over-the-counter products.

His deep expertise also includes senior roles at Enzon Pharmaceuticals and Eisai Inc., where he focused on sales and marketing compliance, FDA promotional issues, and fraud and abuse laws. This background is precisely what a company like Milestone requires as it introduces a novel therapy to the market. Sandoval's responsibilities will span the corporate legal spectrum, from contracts and intellectual property to investor relations and SEC compliance.

“I am very excited to join Milestone at this important time,” Mr. Sandoval stated. “I look forward to partnering with the leadership team to further build upon a strong legal and compliance foundation that will enable successful commercialization, support long-term growth and help drive value creation for shareholders, and continue to benefit the patients we serve.”

A New Frontier in Patient-Led Cardiac Care

CARDAMYST represents a significant paradigm shift for the roughly two million people in the U.S. diagnosed with PSVT. These patients experience sudden episodes of rapid heartbeats, often exceeding 150-200 beats per minute, which can cause severe dizziness, shortness of breath, and chest pain, frequently leading to costly and stressful emergency room visits.

Historically, acute treatment options were limited to medical settings, typically involving intravenous drugs like adenosine or, in some cases, electrical cardioversion. CARDAMYST disrupts this model by empowering patients. As a portable nasal spray, it is designed to be self-administered at the onset of symptoms, wherever the patient may be. This novel calcium channel blocker acts rapidly to convert the heart back to a normal sinus rhythm.

Clinical data from the robust Phase 3 program has been compelling. In the pivotal RAPID study, 64% of patients who self-administered CARDAMYST converted to a normal heart rhythm within 30 minutes, compared to just 31% on placebo. The median time to conversion for the treatment group was approximately 17 minutes, a critical time savings for a patient in distress. The treatment has been shown to have a favorable safety profile, with most side effects being mild and transient, such as nasal discomfort or a runny nose.

This unique delivery method and patient-centric approach position CARDAMYST in a class of its own, differentiating it from both existing hospital-based treatments and long-term preventative therapies like catheter ablation.

The Compliance Gauntlet and Future Growth

The launch of a first-in-class, self-administered product is not without its hurdles. Milestone faces a complex web of regulatory and compliance challenges that require meticulous navigation. The FDA, along with other regulatory bodies like the Office of Inspector General (OIG), heavily scrutinizes how new drugs are promoted to ensure messaging is truthful and not misleading. For a self-administered therapy, clear and compliant patient education is paramount to ensure proper use and safety.

Sandoval's role will be central to establishing the guardrails for all commercial activities. This includes overseeing promotional review processes, ensuring interactions with healthcare professionals adhere to the Sunshine Act, and structuring patient access programs to comply with anti-kickback statutes. Milestone has already signaled a focus on access, with plans to cap copays for eligible commercially insured patients at $25, a strategy that must be executed with careful legal oversight.

For a company that, according to financial data, is burning through cash to fund its commercial launch, a misstep in compliance could result in severe legal and financial penalties, jeopardizing the product's success. While analysts hold a largely positive view of Milestone's prospects, citing CARDAMYST's strong efficacy and market potential, successful execution remains the key variable. The appointment of a seasoned compliance chief is a clear signal to investors and the market that Milestone is prioritizing a robust and defensible launch strategy.

Looking ahead, the company is not resting on its laurels. Etripamil is currently in Phase 3 development for another condition, atrial fibrillation with rapid ventricular rate (AFib-RVR), and in Phase 2 for pediatric PSVT. Furthermore, a marketing application has been accepted for review in Europe, opening a potential new frontier for growth. Sandoval's guidance will be crucial as Milestone navigates these future pathways while cementing CARDAMYST's place in cardiovascular medicine.