Insmed Incorporated (INSM) on Monday reported positive topline results from the Phase 3b ENCORE study evaluating ARIKAYCE in patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not previously received antibiotics. Shares rose more than 10% in pre-market trading.
The ENCORE trial assessed once-daily ARIKAYCE plus multidrug therapy versus placebo plus multidrug therapy over 12 months. Among participants, 82.4% were experiencing their first MAC infection, while 17.6% had a second or third occurrence.
The study met its primary endpoint and all multiplicity-controlled secondary endpoints, demonstrating statistically significant and clinically meaningful improvements in culture conversion rates and respiratory symptom scores.
The safety profile of ARIKAYCE was consistent with prior findings, with no new safety signals observed.
With these results, the company said it has fulfilled a post-marketing requirement from the U.S. Food and Drug Administration, strengthening the clinical foundation for the therapy.
Insmed plans to file a supplemental new drug application in the second half of 2026 to support potential label expansion and seek traditional approval for the existing refractory indication in the U.S. It also plans to submit the data to Japan's Pharmaceuticals and Medical Devices Agency to support a potential label expansion there.
Insmed shares closed at $136 on Friday, down 5.56%.
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