- Insmed (NASDAQ:INSM) is up 77% premarket on increased volume in response to its announcement of positive top-line results from a Phase 3 clinical trial, CONVERT, assessing ALIS (amikacin liposome inhalation suspension) in adult patients with treatment-resistant nontuberculous mycobacterial lung disease caused by mycobacterium avium complex (MAC).
- The study met its primary endpoint of a statistically valid proportion of patients in the ALIS + guideline-based therapy (GBT) cohort achieving culture conversion by month 6 compared to GBT alone.
- Treatment-emergent adverse events were similar between the treatment arms.
- The company plans to pursue accelerated approval in the U.S. where ALIS has Breakthrough Therapy, Fast Track and QIDP status.
- 15 months ago, the company withdrew its European marketing application for the product, branded as ARIKAYCE, after a negative vote by the advisory group CHMP citing the need for more efficacy data (the application was based on Phase 2 results).
- Management will host a conference call this morning at 8:30 am ET to discuss the results.
- Previously: Insmed withdraws Arikayce marketing application in Europe; shares down 13% premarket (June 9, 2016)
- Now read: Insmed's Impending Phase 3 Top-Line Results: Our Deep Dive And Recommendation
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