Biotech Values

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SVNT

It got worse:

FDA extends review time for gout drug

http://finance.yahoo.com/news/FDA-extends-review-time-for-apf-14347854.html

FDA will take additional 3 months to review Savient Pharmaceuticals' gout drug

EAST BRUNSWICK, N.J. (AP) -- Shares of Savient Pharmaceuticals plummeted Thursday evening after the company said federal regulators pushed back the target date to review the company's treatment for gout.

Savient said in a statement the Food and Drug Administration has extended its review for the drug by three months until July 30. FDA also notified the company it will likely reschedule a meeting planned for March 5 to review the company's drug.

Savient has asked the FDA to approve the injectable treatment for gout patients who haven't responded to other therapies. Gout is a painful inflammation and swelling of the joints caused by the buildup of uric acid.

In late December, the FDA said it would give the company's application priority review, meaning regulators would aim to make a decision in six months, instead of the usual 10 months.

Shares of Savient Pharmaceuticals plunged $2.06 percent, or 28 percent, to $2.05 in afterhours trading.