Cell Therapeutics Inc. (NASDAQ: CTIC) shares tumbled nearly 6% to $0.22 this morning, slipping with the broader biotech industry. The company recently met with officials from the U.S. Food and Drug Administration’s Office of New Drugs (OND) to argue its case in support of the company’s belief that the data contained in its New Drug Application (NDA) 22-481 support the conclusion that pixantrone is effective for its planned use.
“We appreciate OND’s consideration of our appeal. �While we understand disputes of this type are a challenging process, we felt compelled to seek this review based on the PIX301 results and lack of approved therapies for these patients with an unmet medical need. �CTI is committed to the advancement of pixantrone,” James A. Bianco, M.D., CEO of Cell Therapeutics stated in the press release.
At the meeting, the OND requested additional analyses from the PIX301 phase III clinical study, which Cell Therapeutics said it intends to submit with expectations that this will reset the time period for OND to provide its decision on the appeal.� The company anticipates a decision in the second quarter of 2011.
On the financial side, Cell Therapeutics reported a wider loss for the fourth quarter as compared with the comparable period previous year, reflecting non-cash payment of deemed dividends on preferred stock.
The company reported a net loss of $34.12 million, or $0.04 per share as compared to $27.38 million or $0.05 per share in the previous year. The increase in net loss resulted from an increase in non-cash deemed dividends on preferred stock related to financing activities. The net operating expenses for the quarter were $16.32 million, a decrease from $26.24 million in the same quarter last year.
For the full year, the company recorded a net loss of 147.56 million or $0.22 per share as compared to $116.76 million or $0.25 per share a year ago. The net operating expenses reported were $75.1 million as compared to $81.6 million for the same period in 2009. The decrease in net operating expenses was due to a decrease in research and development and selling, general and administrative expenses in 2010. The company recognized a $10.2 million gain on the sale of an asset and incurred $4.0 million in restructuring charges in 2009.
Cell Therapeutics stock is currently trading at $0.226. The stock is down 3.87% from its previous close. Cell Therapeutics shares stock touched the high of $0.23 and lowest price in today�s session is $0.22. The company stock�s beta is 5.85.
The company stock has traded in the range of $0.12 and $1.13 during the past 52 weeks. The company�s market cap is $203.94 million.
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