Puma Biotechnology Inc. (PBYI) said it will delay filing for U.S. regulatory approval of its experimental breast cancer treatment by as much as a year.
The company’s shares fell 15 percent to $192.36 at 9:36 a.m. in New York, the most since June. The drugmaker announced yesterday that it would apply for Food and Drug Administration clearance of neratinib in the first quarter of 2016, instead of the first half of 2015. The stock had more than doubled this year through yesterday’s close.
The Los Angeles-based biotechnology company is applying to use neratinib in early stage cancer patients as a follow-on treatment after initial therapy. The FDA wants long-term data on whether the drug caused other cancers during pre-clinical tests in animals, Puma said in its statement.
Puma originally said it would apply to use neratinib for HER2-positive metastatic breast cancer, a sicker, higher-risk group, and now plans to apply first for extended adjuvant HER2-positive early stage breast cancer, the company said. HER2 is a genetic mutation that can drive a cancer’s growth.
Neratinib is Puma’s only drug under development. It is also in testing for other forms of breast cancer, lung cancer, and other malignancies.
The company’s shares almost quadrupled in July when it announced positive trial results for the drug.
To contact the reporter on this story: Caroline Chen in New York at cchen509@bloomberg.net
To contact the editors responsible for this story: Crayton Harrison at tharrison5@bloomberg.netDrew Armstrong, Andrew Pollack
