Shares of InterMune Inc. rose Monday after the Food and Drug Administration gave the biotechnology company's developing lung disease treatment fast-track status, allowing for a quicker regulatory review.
The stock gained 18 cents, or 1.2 percent, to end at $15.11. Shares have traded between $11.72 and $28.07 over the last 52 weeks.
Early Monday, the company said the FDA gave pirfenidone the special review designation. The drug is being developed as a treatment for idiopathic pulmonary fibrosis.
A fast-track designation means the company can submit clinical trial data to the FDA as it becomes available, rather than having to wait to submit it all at once. The status is reserved for drugs aimed at treating serious conditions for which there are few or no available treatments.
There are currently no approved treatments for idiopathic pulmonary fibrosis.
"Top-line pirfenidone results from InterMune's pivotal Phase III CAPACITY (study) program are expected in January 2009, and assuming positive data, we believe this morning's announcement will likely accelerate the regulatory and commercialization timelines," Thomas Weisel Partners analyst Stephen Wiley said in a note to investors.
He reaffirmed a $26 price target and "Favorable" rating on the stock.
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