Avalyn Pharma Inc.

Avalyn Pharma Inc. が 2026年8月12日 に発表した内容

企業自身の 8-K から。

決算説明会

Avalyn Pharma Inc. の決算説明会の書き起こしはありません。

経営陣の発言

“Completing global enrollment in MIST marks a significant milestone for Avalyn, and the degree of over-enrollment in this study is a testament to the high level of interest from investigators and patients,”

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株価の反応

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Avalyn Pharma Inc. の事業内容

Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has indicated encouraging safety and clinical activity across Phase 1b and multi-year open-label extension trials, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies.

発表資料の末尾に記載された、企業自身による説明です。