Monday, October 30, 2006

Genta Inc. said Monday the Food and Drug Administration will take another 90 days to review its marketing application for the cancer drug Genasense after the drug developer presented the agency with additional data.

Shares of Genta rose nearly 6 cents, or 8 percent, to 86 cents in pre-market activity on the INET electronic exchange. Shares have fluctuated between 35 cents and $3.48 over the past 52 weeks.

In September, an FDA advisory panel recommended that the agency not approve Genasense, questioning the significance of the drug study's primary endpoint. Uncertainty about the data drove Genta's share price down 63 percent over two days to close at 51 cents on Sept. 6.

The agency will now render a decision on the drug by Jan. 29, rather than Oct. 29, according to the company. Genta requested a meeting with the FDA and said the agency will consider the new data in the application.

Genta said the new information reinforces the conclusion that Genasense significantly increased the number of lasting remissions in leukemia patients compared with using chemotherapy alone.


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