Reuters: Regulatory News: UPDATE 1-FDA lifts second hold on trials of Insmed lung drug

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UPDATE 1-FDA lifts second hold on trials of Insmed lung drug May 7th 2012, 12:51 Mon May 7, 2012 8:51am EDT May 7 (Reuters) - Insmed Inc 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 48 percent in premarket trade. 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. Last year, the FDA placed Arikace's trials on hold for treating two lung diseases based on an initial review of results from a long-term study on rats. In January, the FDA lifted a hold on the trial for non-tuberculous mycobacteria (NTM) lung disease -- a form of lung disease that currently has no approved cure. The company's shares, which have gained nearly 30 percent since the FDA lifted the first hold, closed at $2.70 Friday on Nasdaq. They were up 48 percent at $4.00 in premarket trade on Monday.

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