InterMune’s Lung Drug Gets Backing From FDA Panel
Another day, another stock-price jump.
First, the preliminaries: An advisory panel this afternoon recommended the FDA approve a lung drug developed by InterMune, with majorities of the outside experts saying the proposed treatment appeared effective and safe.
The FDA is expected to decide by early May whether to go along with the panel’s recommendation on pirfenidone, which is intended to treat patients with idiopathic pulmonary fibrosis. The FDA usually follows the lead of its advisory committees.
This all comes as good news for investors in InterMune, whose shares streaked nearly 60% higher Friday because the questions posed by the FDA staff for today’s advisory committee meeting weren’t uniformly negative.
The stock price then barely budged yesterday and trading in the shares was halted today in anticipation of the meeting news. But in after-hours trading today, the news sent the shares soaring up 65% to $38.43. That compares with the stock’s price under $15 at the close last Thursday.
The experts voted 7-5 on the question of data for pirfenidone showing “substantial evidence” of effectiveness. The medicine passed the safety vote 9-3. InterMune had told the panel that “pirfenidone provides a clinically meaningful benefit to patients by reducing decline in lung function.”
Panel member Leslie […]
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