(-) FDA lifts hold on trials of Insmed lung drug, shares up (Reuters) - May 7, 2012 - Insmed stopped pursuing the development of its cancer products rhIGFBP-3 & INSM-18
Drug discontinuation • Oncology
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(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 47 percent.
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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.
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