Cell Therapeutics Plummeting on NDA Withdrawl
Shares of Cell Therapeutics (NASDAQ: CTIC) are seeing much pressure during Monday's trading session after the company announced the withdrawal of its new drug application.
Cell Therapeutics voluntarily withdrew its New Drug Application for Pixuvri (pixantrone) for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.
The NDA was withdrawn because, after communications with the U.S. Food and Drug Administration, CTI needed additional time to prepare for the review of the Pixuvri NDA by the FDA's Oncologic Drugs Advisory Committee at its February 9, 2012 meeting.
Prior to withdrawing the NDA, CTI requested that the FDA consider rescheduling the review of the Pixuvri NDA to the ODAC meeting to be held in late March. The FDA was unable to accommodate CTI's request to reschedule, and given the April 24, 2012 Prescription Drug User Fee Act ("PDUFA") date, the only way to have Pixuvri possibly considered at a later ODAC meeting was for CTI to withdraw and later resubmit the NDA. CTI plans to resubmit the NDA in 2012.
Currently, shares of Cell Therapeutics are trading about 18% lower at $1.08.
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