CAMBRIDGE, Mass., July 1, 2026
Apnimed has strengthened its executive leadership team with the appointments of Michael Kelly as Chief Financial Officer (CFO) and Steven Spector as Chief Legal Officer and Head of Corporate Affairs, reinforcing the company’s commercial readiness as it advances AD109, its investigational oral therapy for obstructive sleep apnea (OSA), toward potential U.S. commercialization. The appointments follow the recent naming of Kevin Lind as Chief Executive Officer and form part of Apnimed’s planned leadership succession strategy designed to support the company’s transition from a late-stage clinical pharmaceutical company to a potential commercial-stage organization. With AD109 currently under FDA review following submission of its New Drug Application (NDA) and a potential PDUFA action date expected in the first quarter of 2027, the leadership expansion represents a significant milestone in Apnimed’s long-term growth strategy. The company aims to transform OSA treatment through the development of once-nightly oral therapies that target the underlying neurobiology of sleep-related breathing disorders while offering an alternative to cumbersome devices and invasive surgical interventions.
Experienced Industry Leaders Strengthen Commercial Readiness
The appointment of Michael Kelly brings more than 25 years of healthcare finance leadership experience to Apnimed. Most recently serving as Global Co-Head of Healthcare Investment Banking at Cantor Fitzgerald, Kelly led numerous strategic transactions totaling more than $30 billion in capital markets and mergers and acquisitions across the global biopharmaceutical sector. As Chief Financial Officer, he will oversee the company’s capital strategy, financial operations, and commercialization planning, positioning Apnimed for its next phase of growth as it prepares for the potential launch of AD109. Kelly succeeds Ramzi Benamar, who played a key role in strengthening the company’s financial foundation and supporting several strategic corporate initiatives.
At the same time, Steven Spector joins the executive leadership team with more than 25 years of biotechnology legal, compliance, and business development experience. Most recently, he served as Executive Vice President, Head of Business Development, General Counsel, Chief Compliance Officer, and Corporate Secretary at Longboard Pharmaceuticals, contributing to the company’s successful $2.6 billion acquisition by H. Lundbeck A/S in 2024. His expertise is expected to strengthen Apnimed’s legal infrastructure, compliance framework, and corporate governance as commercialization efforts continue.
AD109 Advances Toward Potential FDA Approval
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Apnimed’s executive appointments come at a pivotal time as the company prepares for the possible commercialization of AD109, an investigational once-daily oral therapy designed to become the first pharmacological treatment targeting the neuromuscular root cause of obstructive sleep apnea. AD109 combines aroxybutynin, a novel antimuscarinic agent, with atomoxetine, a selective norepinephrine reuptake inhibitor, to improve oxygenation during sleep by reducing upper airway collapse. Unlike traditional OSA treatments that rely on continuous positive airway pressure (CPAP) devices or surgical intervention, AD109 has been developed to provide a more convenient oral treatment option.
The therapy has successfully completed two Phase 3 clinical trials, including the SynAIRgy study, with results published in a peer-reviewed scientific journal. Following completion of these pivotal studies, Apnimed submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration, with the company expecting a potential PDUFA action date in the first quarter of 2027, subject to FDA acceptance for review.
Supporting Growth in the Obstructive Sleep Apnea Market
Obstructive sleep apnea remains one of the most common yet underdiagnosed chronic diseases worldwide, affecting an estimated 80 million people in the United States and nearly one billion individuals globally. The disorder significantly increases the risk of cardiovascular disease, neurocognitive impairment, metabolic disorders, and premature mortality, while many patients remain untreated because of limited therapeutic options and poor adherence to device-based treatments.
Apnimed believes its expanding leadership team will help accelerate commercial planning and market preparation as it works toward introducing a potential first-in-class oral therapy capable of transforming the treatment landscape for OSA. With strengthened expertise in finance, legal affairs, corporate strategy, and commercialization, the company is positioning itself to support future regulatory milestones and expand access to innovative therapies that may improve oxygenation, restorative sleep, and long-term patient outcomes.
Source: Apnimed press release
