Cell Therapeutics Inc. (NASDAQ: CTIC) caught a boost this morning after the U.S. Food & Drug Administration (FDA) accepted its new drug application for pixantrone, an experimental drug for the treatment of relapsed, aggressive non-Hodgkin's lymphoma. The FDA's action date for review of pixantrone will be set by Sept. 4.

CTIC surged more than 6% out of the gate this morning, tagging a session high of $1.80, but the low-priced shares have since whittled their gains. The equity, which has rallied 1,107.1% year-to-date, is currently trading sideways between support at its 10-week moving average and resistance near the $2 level.

Continue reading Cell Therapeutics spikes on FDA approval

Cell Therapeutics spikes on FDA approval originally appeared on BloggingStocks on Mon, 24 Aug 2009 12:20:00 EST. Please see our terms for use of feeds.

Adolor Corp. (NYSE:ADLR) market cap was nearly halved this morning. ADLR share price plunged over 43% this morning in heavy trading as it went from yesterday's close of $13.94 to $7.91.

The Food and Drug Administration asked Adolor to supply it with more information regarding the company's Entereg drug, dealing it a major blow. Analysts were expecting an FDA approval of the drug this week.

Entereg, a drug aimed at helping patients recover after bowel surgery, needs to be tested further, the FDA said, and requested more safety data. The analysis involves serious cardiovascular events and a risk management plan study should be completed in the first quarter of 2007, with data available in the second.

While GlaxoSmithKline PLC (NYSE:GSK) is also a developer of the Entereg, its shares are actually up 0.71% despite this latest delay being one of many lately. One of GSK's big hopes, its cervical cancer vaccine Cervarix, had seen delay in U.S. filing last month, and diabetes drug Redona showed poor results. A few others had troubles lately.

Meanwhile, Cell Therapeutics Inc. (NASDAQ:CTIC) shares also lost over 10% of their value. CTIC announced on Friday that it temporarily suspended enrollment in its Pioneer lung cancer, Xyotax, clinical trial on recommendation of the Data Safety Monitoring Board as it awaits follow up-data of recently enrolled patients. Some of the patients in the study had died, but the company needs to study the reason -- natural disease progression or some other effect.

Adolor plunges 43% on FDA approval delay, CTIC down 10% originally appeared on BloggingStocks on Mon, 06 Nov 2006 12:36:00 EST. Please see our terms for use of feeds.