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Insmed Incorporated announced positive topline results from the Phase 3b ENCORE study evaluating ARIKAYCE plus azithromycin and ethambutol versus placebo plus the same multidrug therapy in 425 patients with newly diagnosed Mycobacterium avium complex lung infection, meeting the primary endpoint of change from baseline in Respiratory Symptom Score at Month 13 (17.77 vs 14.66 points, p=0.0299) and all multiplicity-controlled secondary culture conversion endpoints. The company plans supplemental NDA filing with FDA and data submission to PMDA in second half of 2026 for potential label expansion.
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Voluntary
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8-K
, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act
Other Events. On March 23, 2026 , the Company issued a press release announcing positive topline results from the ENCORE Study. Topline efficacy results from th
Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press release issued by Insmed Incorporated on March 23, 2026. 99.2 Insmed Incorpor