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Related Topics >> GenMab | ofatumumab | FDA delay | Arzerra

Genmab shares slide on FDA delay

Asking for more time to review chemistry and manufacturing data, the FDA pushed back its deadline to make a decision on the leukemia drug Arzerra by three months. The news cost Genmab about seven percent of its share price. Genmab and its partner, GlaxoSmithKline, are seeking an accelerated approval based on data from a small trial with no comparison arm. The FDA now has until October 31 to decide if the drug warrants an approval. Release | Report


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