Shares of the company fell about 16 percent to $2.95 in
pre-market trade. They closed at $3.50 on Thursday on Nasdaq.On Aug. 1, the company said the FDA placed a hold on two
late-stage trials for the drug, in cystic fibrosis patients with
Pseudomonas lung infections and patients with non-tuberculous
mycobacterial (NTM) lung disease.FDA now requires the company to conduct a mid-stage study in
adult NTM patients to provide efficacy and safety data, and to
further revise the assessment of a rat carcinogenicity study
findings.”Now that we have responses from the FDA with respect to
both clinical holds, we are seeking further inputs from the
agency in order to gain a better understanding of their requests
regarding CF and NTM,” Chief Executive Timothy Whitten said in a
statement.