shares plunged early Monday after the drugmaker withdrew a new drug application for its pancreatic cancer treatment Orathecin.
The California-based company said it made the move based on "feedback indicating that the current data package would not be sufficient to gain approval" for Orathecin capsules at this time in the U.S.
"Based on the feedback we received, we decided it was best for the long-term development of Orathecin to withdraw the application," the company said. "After we review the FDA's complete findings, we will determine the most appropriate course of action for Orathecin in the U.S."
Shares fell 88 cents, or 12.5%, to $6.17 in premarket trading.
SuperGen originally submitted the new drug application for Orathecin on Jan. 26, 2004. Orathecin has orphan drug status in both the U.S. and Europe for the treatment of pancreatic cancer. The company said its European drug application filing remains on track.
The experimental drug is for the treatment of pancreatic cancer patients who have failed at least one prior chemotherapy regimen.