BioCentury
ARTICLE | Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

October 17, 2011 7:00 AM UTC

Insmed Inc. (NASDAQ:INSM) fell $1.34 (31%) to $3.01 on Monday after FDA told the company it is maintaining a clinical hold on a planned Phase III trial of Arikace in cystic fibrosis patients with Pseudomonas aeruginosa infection. The agency asked for a nine-month dog inhalation toxicity study as well as a proposed CF patient population and disease state where the risk-benefit profile of Arikace may be "more favorable."

Later in the week, Insmed said FDA maintained a hold on a planned Phase III trial of Arikace in patients with non-tuberculosis mycobacteria (NTM) lung infection. According to Insmed, the agency said it still has "insufficient information" to assess the risks of Arikace in NTM patients and asked Insmed to conduct an additional Phase II trial before proceeding into Phase III. Insmed was off $1.03 (24%) to $3.32 on the week...