Insmed reported strong financial results for the fourth quarter and full-year 2024, highlighted by a 19% increase in total revenue for ARIKAYCE, which reached $363.7 million, exceeding the upper end of guidance. The company reiterated its 2025 global revenue outlook for ARIKAYCE at $405 million to $425 million, reflecting continued double-digit growth.

A major milestone was the FDA’s acceptance of Insmed’s New Drug Application (NDA) for brensocatib for bronchiectasis, granting Priority Review with a target action date of August 12, 2025. If approved, a U.S. launch is expected in the third quarter of 2025, with regulatory submissions in the EU, UK, and Japan planned for later in the year.

The company also made progress across its pipeline, completing enrollment for the Phase 3 ENCORE study of ARIKAYCE for Mycobacterium avium complex (MAC) lung disease, with topline data expected in Q1 2026. Meanwhile, the Phase 2b study of TPIP for pulmonary arterial hypertension (PAH) is set to report topline results in mid-2025, and a Phase 3 study for TPIP in pulmonary hypertension associated with interstitial lung disease (PH-ILD) is planned for the second half of the year.

Insmed ended 2024 with a strong cash position of approximately $1.4 billion, supporting its continued investment in growth. CEO Will Lewis emphasized that the company is well-positioned for a transformative 2025, balancing commercial execution with pipeline expansion, including new gene therapy programs for Duchenne muscular dystrophy (DMD), ALS, and Stargardt disease.