Shares of Pharmacyclics were hammered this morning after the company announced that the FDA had refused to accept its NDA for a new therapy to fight lung cancer that has spread to the brain. Pharmacyclics said that the agency had issued a "refuse to file" letter for Xcytrin, saying it was unable to review the clinical data on the therapy. The company says that it is reviewing the program.
"We will be evaluating our options with Xcytrin for the brain metastases indication and determine the best path forward," said Richard A. Miller, M.D., president and CEO of Pharmacyclics. "Beyond this indication, the clinical development program with Xcytrin continues on multiple fronts. Several ongoing trials are evaluating Xcytrin in non-small cell lung cancer and other cancers. We are also moving forward with several other novel compounds, which are in clinical and preclinical development."
- check out this press release
- read the AP report on Pharmacyclics
Pharmacyclics shares plunge after Xcytrin flunks Phase III. Report
Pharmacyclics acquires cancer treatment candidates from Celera. Report