Shares of Forest Laboratories, Inc. (FRX) are down more than 9% in Tuesday's after-hours session on news that an advisory panel of the FDA voted against approving the New Drug Application for its pulmonary drug candidate Daxas, or roflumilast.
FRX shares, which closed Wednesday's regular trading at $32.46, touched an after-hours low of $28.39. During the day's regular trade, the stock had reached a high of $32.91, with a volume of 17.31 million shares.
The panel, which reviewed Daxas for treating chronic obstructive pulmonary disease, rejected Daxas on a 10-5 vote citing Forest didn't provide enough evidence to support an approval. Rumors that the drug might fail to clear the pane's approval had dragged down FRX stocks for around a week.
The New Drug Application for roflumilast, which was submitted in July 2009, included six long-term randomized, placebo-controlled, parallel-group studies in 7,453 COPD patients.
According to the company, all six studies consistently demonstrated efficacy of 500 mcg roflumilast over placebo in reducing the rate of moderate to severe exacerbations and improving lung function.
COPD is the fourth leading cause of chronic morbidity and mortality in the United States and there is an unmet medical need.
In after-hours trading, FRX is currently losing 8.35%, and is trading at $29.75 on a volume of 1.59 million shares on the New York Stock Exchange.
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