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Insmed Incorporated Message Board

  • blank2thisone blank2thisone Jul 1, 2013 8:04 AM Flag

    Wall street Journal: Insmed's Arikace Gets FDA Fast-Track Designations for Lung Infections

    Insmed Inc. (INSM) said the U.S. Food and Drug Administration designated its investigational drug Arikace as a qualified infectious disease product and granted Arikace a fast-track designation for the treatment of non-tuberculous mycobacteria lung infections.

    Insmed is currently enrolling patients in a Phase 2 clinical trial of Arikace, or liposomal amikacin for inhalation, to treat NTM lung infections.

    Shares jumped 9% to $13.03 premarket as the fast track designation is intended to expedite the review of new drugs that have the potential to serve unmet medical needs in serious or life-threatening conditions. The stock has climbed 79% since the start of the year through Friday's close.

    The qualified infectious disease product designation allows Insmed to benefit from certain incentives for the development of new antibiotics, including more frequent and ongoing dialogue with FDA, priority review and a five-year extension of exclusivity, if Arikace is ultimately approved by the FDA.

    Separately, the biopharmaceutical company said a Phase 3 study showed a once-daily dose of Arikace for pseudomonas aeruginosa in cystic fibrosis patients conducted wasn't inferior to a twice-daily dose of TOBI, or tobramycin inhalation solution, meaning Arikace met the study's primary endpoint.

    Overall, secondary endpoints showed comparability of once-daily Arikace with twice-daily TOBI consistent with the primary endpoint of the study

    Sentiment: Strong Buy

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    • Insmed Inc. (INSM) said the U.S. Food and Drug Administration designated its investigational drug Arikace as a qualified infectious disease product and granted Arikace a fast-track designation for the treatment of non-tuberculous mycobacteria lung infections.

      Insmed is currently enrolling patients in a Phase 2 clinical trial of Arikace, or liposomal amikacin for inhalation, to treat NTM lung infections.

      Shares jumped 9% to $13.03 premarket as the fast track designation is intended to expedite the review of new drugs that have the potential to serve unmet medical needs in serious or life-threatening conditions. The stock has climbed 79% since the start of the year through Friday's close.

      The qualified infectious disease product designation allows Insmed to benefit from certain incentives for the development of new antibiotics, including more frequent and ongoing dialogue with FDA, priority review and a five-year extension of exclusivity, if Arikace is ultimately approved by the FDA.

      Separately, the biopharmaceutical company said a Phase 3 study showed a once-daily dose of Arikace for pseudomonas aeruginosa in cystic fibrosis patients conducted wasn't inferior to a twice-daily dose of TOBI, or tobramycin inhalation solution, meaning Arikace met the study's primary endpoint.

      Overall, secondary endpoints showed comparability of once-daily Arikace with twice-daily TOBI consistent with the primary endpoint of the study

    • Hmmm, wonder why there's no sell off??

      Sentiment: Strong Buy

 
INSM
20.33+1.33(+7.00%)Mar 5 4:00 PMEST

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