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PRINCETON, N.J. - Biotechnology company Medarex Inc. said late Friday the Food and Drug Administration's request for more data on its cancer drug candidate will delay the application process into next year.
Medarex shares plunged $1.11, or 13.9 percent, to $7.10 in after-hours trading. The stock fell 17 cents, or 2.1 percent, to close the regular trading session at $8.01.
Experimental drug ipilimumab, now in late-stage studies, is aimed at treating advanced metastatic melanoma, a deadly type of skin cancer. The FDA has asked for additional overall survival data in order to consider it for approval. Medarex and partner Bristol-Myers Squibb Co. said they are discussing changing the goal of the current study to measure the overall survival rate.
Like many cancer treatment studies, the main goal of the study is progression-free survival, or the amount of time a patient remains cancer-free while taking the drug.
"Revised timelines are under development, but a BLA (application) for ipilimumab will not be submitted to the FDA in 2008," Medarex said in a statement.
The companies also have ongoing midstage studies in prostate cancer and lung cancer.
Shares of New York-based Bristol-Myers Squibb, meanwhile, rose 1 cent to $22.16 in after-hours trading after falling 6 cents to close at $22.15.
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