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Insmed Incorporated Message Board

  • justarook04 justarook04 May 22, 2014 3:41 PM Flag

    Zacks from today (notice focus on PH II Primary failure) GEEZ

    Insmed Inc. (INSM) recently announced positive additional data from a phase II trial on pipeline candidate, Arikayce, at the American Thoracic Society’s Annual Meeting 2014.

    Insmed is evaluating candidate Arikayce for the treatment of patients suffering from treatment resistant nontuberculous mycobacterial (:NTM) lung infections.

    The randomized, double-blind phase II study (n=89) evaluated Arikayce plus standard of care treatment vis-à-vis standard of care treatment plus placebo in treatment resistant NTM lung infected adults for 84 days. These patients were on American Thoracic Society/Infectious Disease Society of America (ATS/IDSA) guideline therapy for a minimum period of six months before screening.

    These patients also continued to have positive mycobacterial cultures.

    Post randomization, the eligible patients had the option to receive Arikayce once daily for an additional 84 days in an open-label design.

    It was observed that 21 of the 68 patients eligible were culture negative for NTM at the end of 168 days. In addition, the number of patients with negative cultures increased from the double blind phase of the trial.

    The encouraging additional data should somewhat relieve the investors. Insmed suffered a setback in Mar 2014 when Arikayce failed to meet the primary objective in the double blind phase of the trial.

    The primary objective of the phase II study was a semi-quantitative measurement of the difference in mycobacterial density on a seven-point scale from baseline to the end of the randomized portion of the study. However, Arikayce failed to meet the pre-specified level for statistical significance.

    Consequently, Insmed now plans to provide the trial results to regulatory agencies in the U.S. and Europe in the coming months to determine the future development of Arikayce.

    We note that Arikayce enjoys orphan drug designation for treating NTM both in the U.S. and EU. Insmed also applied for Breakthrough Therapy Designation for Arikayce in the US

    Sentiment: Buy

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    • Consequently, Insmed now plans to provide the trial results to regulatory agencies in the U.S. and Europe in the coming months to determine the future development of Arikayce.= 6 to 12 month delay just for a decision

    • you left out :Data on Insmed's Arikayce Zacks By Zacks Equity Research
      Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.The encouraging additional data should somewhat relieve the investors. Insmed suffered a setback in Mar 2014 when Arikayce failed to meet the primary objective in the double blind phase of the trial.

      The primary objective of the phase II study was a semi-quantitative measurement of the difference in mycobacterial density on a seven-point scale from baseline to the end of the randomized portion of the study. However, Arikayce failed to meet the pre-specified level for statistical significance.Consequently, Insmed now plans to provide the trial results to regulatory agencies in the U.S. and Europe in the coming months to determine the future development of Arikayce.Insmed is also developing Arikayce for the treatment of pseudomonas aeruginosa in patients suffering from cystic fibrosis.Insmed currently carries a Zacks Rank #3 (Hold

 
INSM
15.96+0.70(+4.59%)Jan 29 4:00 PMEST

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