Reuters: Global Markets: FDA lifts hold on trials of Insmed lung drug, shares up

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FDA lifts hold on trials of Insmed lung drug, shares up May 7th 2012, 14:06 Mon May 7, 2012 10:06am EDT (Reuters) - Insmed Inc (INSM.O) can resume the development of its key drug Arikace after the U.S. health regulator lifted a second clinical hold on the drugmaker's experimental treatment for lung disease, sending its shares up 47 percent. Insmed had been in discussions with the U.S. Food and Drug Administration to finalize the details of a potential late-stage study on cystic fibrosis patients with Pseudomonas lung infections. The FDA placed on hold trials for treating two lung diseases with Arikace last year, based on an initial review of results from a long-term study on rats. However, the FDA lifted its hold on the trial for treating non-tuberculous mycobacteria (NTM) lung disease -- which currently has no approved cure -- in January this year. The company has all its resources focused on Arikace. In December, it stopped all activities related to its protein complex IPLEX. Insmed, which had cash and equivalents of $78.4 million on December 31, 2011, also stopped pursuing the development its cancer products rhIGFBP-3 and INSM-18. The company's shares, which have gained nearly 30 percent since the FDA lifted the first hold, touched a $4.08 to become one of the top percentage gainers on Monday on the Nasdaq. They were trading up 47 percent at $3.97. (Reporting by Esha Dey and Vidya P L Nathan in Bangalore; Editing by Sreejiraj Eluvangal) Link this Share this Digg this Email Reprints

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