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Shares of Intermune soar after dodging FDA Review

 

By Armando Duke

(AXcess News) Houston - Shares of Intermune (Nasdaq: ITMN) soared Friday morning after the maker of a drug to treat lung scarring dodged an FDA Review over safety concerns that it may not do what Intermune claims.  Shares of Intermune were up more than 62% less than 15 minutes after the opening bell in New York.

Intermune released a statement early Friday morning saying, the "U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (NDA) for pirfenidone, InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function."

Dispite the Review, shares of Intermune were up as high as 80% in pre-market trading.

The FDA had noted that "only one of the Company's two key trials prove the product worked."  In the second trial, many of the patients that were given pirfenidone dropped out of the study, complaining of side effects.

"The clinical program suggests that pirfenidone has some safety signals that include gastrointestinal issues, liver abnormalities, reactions to sunlight and rash," the FDA said.

Yet Intermune stated this morning that pirfenidone, which is to be sold under the trade name Esbriet, side effects were not life-threatening and could be controlled.  That the Company's drug was the only one available to treat lung scarring.



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