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Insmed Incorporated Message Board

  • jsblvbjb jsblvbjb Mar 27, 2014 3:23 PM Flag

    Worth the read: great information on NTM trial and price target:

    Insmed Update
    INSM : NASDAQ : US$15.91
    BUY 
    Target: US$30.00
    Insmed is focused on developing novel, targeted inhaled
    therapies for the treatment of serious orphan lung diseases. Its
    lead product candidate is Arikace, a liposomal formulation of FDA
    approved antibiotic, amikacin.
    All amounts in US$ unless otherwise noted.
    Life Sciences — Biotechnology
    Investment recommendation
    Reiterate BUY, $30 PT on Arikace’s potential in nontuberculous
    mycobacteria (NTM).
    INSM’s lead drug Arikace is an inhaled liposomal form of FDA-approved amikacin. We view the Ph2 US NTM data as clearly positive, and culture conversion/safety data as supportive of expedited approval. Our $30 target is based on a pNPV analysis.
    Investment highlights
     We see a clear, and likely abbreviated path to approval strongly
    supported by culture conversion and QoL data. We think six-month
    extension culture conversion, conversion over time, and QoL data to
    be presented May 20th at ATS (San Diego) will support a subpart H
    filing, a positive AdComm and conditional approval, given what we
    see as strong clinically meaningful data in an unmet need.
     Primary endpoint statistics confounded by small numbers, unrelated
    death. The sensitivity of the primary endpoint Wilcox rank sum
    analysis is underscored by the change in p-value from p=0.148 to
    p=0.02 when a repeated measures analysis is conducted excluding
    the unrelated patient death. We think FDA’s previous strong focus
    on cures/QoL (supported by our talks with KOLs) hasn’t changed.
     QDIP/GAIN gives FDA the flexibility to focus on the drug’s activity:
    we think breakthrough status is highly likely. While some investors
    are focused on safety, we think the lack of renal and ototoxicity and
    note FDA has approved antibiotics for unmet needs with much more
    problematic safety profiles

    Sentiment: Strong Buy

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