Sat, Dec 27, 2014, 5:00 AM EST - U.S. Markets closed

Recent

% | $
Quotes you view appear here for quick access.

Insmed Incorporated Message Board

  • gt_pharma gt_pharma Mar 28, 2013 8:07 AM Flag

    Orphan drug designation!!!!!!

    ARIKACE Receives Orphan Drug Designation for Treating Infections Caused by Non-Tuberculous Mycobacteria

    MONMOUTH JUNCTION, NJ -- (Marketwire) -- 03/28/13 -- Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious lung diseases in orphan indications that are often life-threatening, today announced that ARIKACE®, the Company's Iiposomal amikacin for inhalation, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the treatment of infections caused by non-tuberculous mycobacteria (NTM).

    Sentiment: Strong Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • March 28, 2013
      ARIKACE Receives Orphan Drug Designation for Treating Infections Caused by Non-Tuberculous Mycobacteria
      MONMOUTH JUNCTION, NJ -- (Marketwire) -- 03/28/13 -- Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious lung diseases in orphan indications that are often life-threatening, today announced that ARIKACE®, the Company's Iiposomal amikacin for inhalation, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the treatment of infections caused by non-tuberculous mycobacteria (NTM).

      Orphan drug designation provides certain exclusivity benefits, tax credits for certain research and a waiver of the New Drug Application user fee. According to a recent company-sponsored patient chart study conducted by Clarity Pharma Research, approximately 50,000 cases of NTM lung disease were treated by physicians in the U.S. during 2011. There is no current FDA-approved treatment for NTM lung infection.

      "The FDA's timely approval of our request for orphan drug designation for ARIKACE to treat non-tuberculous mycobacteria is a key milestone that supports our broader strategy for this potentially life-saving therapy," stated Will Lewis, President and Chief Executive Officer of Insmed. "NTM is a chronic, debilitating disease, and currently available treatments have shown limited efficacy and tolerability. We continue to enroll patients in our phase 2 clinical trial of ARIKACE to treat NTM patients in the U.S. and Canada and look forward to having top-line data by the end of this year."

 
INSM
15.37+0.08(+0.52%)Dec 26 4:00 PMEST

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.
Virgin America Inc.
NASDAQFri, Dec 26, 2014 4:00 PM EST
3D Systems Corporation
NYSEFri, Dec 26, 2014 4:00 PM EST
Tesla Motors, Inc.
NASDAQFri, Dec 26, 2014 4:00 PM EST