Pharmacyclics climbed 13 percent to $100.71 at 12:51 p.m. New York time after reaching $102.05, the highest intraday price since the shares began trading Oct. 25, 1995. The medicine was submitted as a “breakthrough therapy,” which is designed to speed approval, the company said in a statement today.
The filing asks the Food and Drug Administration to clear the Sunnyvale, California-based company’s therapy, ibrutinib, for treatment on two types of lymphoma. Pharmacyclics had said it would submit the application by the end of the third quarter, and seeking two indications was unexpected, Michael King, an analyst at JMP Group Inc. in New York, said in a research note.
“We predict the drug is on the market before the end of this calendar year,” Michael Yee, an analyst with RBC Capital Markets in San Francisco, said in a research note. Such an approval would put the drug at least a year ahead of a possible competitor from Gilead Sciences Inc. (GILD:US) and two years ahead of one from AbbVie Inc. (ABBV:US), he said.
FDA approval is being sought for ibrutinib as a therapy for mantle cell lymphoma as well as chronic lymphomatic leukemia/small lymphocytic lymphoma, an indication the analysts said wasn’t anticipated yet. In February, the FDA gave the drug “breakthrough” status for mantle cell.
Ibrutinib blocks an enzyme called Bruton’s tyrosine kinase that aids certain cancers in spreading.
Johnson & Johnson, based in New Brunswick, New Jersey, gained less than 1 percent to $89.03.
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