ArQule Inc. (ARQL), a maker of experimental cancer drugs, plunged the most in 16 years after it halted a study of a lung-tumor treatment that failed to meet goals for improving survival rates.
The drugmaker, which has no products on the market, fell 56 percent to $2.18 at the close in New York, for its biggest drop since October 1996 when the Woburn, Massachusetts-based company first offered shares to the public. A panel of scientific advisers recommended an early end to the trial of tivantinib, the cancer medicine ArQule is trying to develop with Tokyo-based Daiichi Sankyo Co. (4568), the companies said today in a statement.
The announcement was the second setback since August for tivantinib, which ArQule called its “lead product candidate” in the statement. In an Aug. 29 regulatory filing, the company said another partner, Tokyo-based Kyowa Hakko Kirin Co. (4151), had temporarily suspended enrollment in a second trial, dubbed Attention, because of safety concerns. ArQule today said the newly halted trial, known as Marquee, found no safety issues.
“We were waiting for a ‘clean’ safety signal from the Marquee study to lift the overhang created by the partial halt from the Attention study,” Adnan Butt, an RBC Capital Markets analyst in San Francisco, said today in a note to clients. Resuming enrollment in the Attention trial “would have been a positive but is now questionable, in our view.”
No Safety Issues
Still, the lack of safety issues in the Marquee study was important and indicates studies of tivantinib are likely to continue, he said.
The Marquee trial was testing the drug in patients with non-small cell lung cancer, ArQule said. The drug is in the third of three stages usually required for U.S. regulatory approval, the company said.
“We are disappointed that the Marquee trial did not provide statistically significant results for overall survival in a disease and treatment setting which remains a major unmet medical need,” Paolo Pucci, ArQule’s chief executive officer, said in the statement.
ArQule shares have fallen 61 percent so far this year.
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