September 14, 2010 - The CTIC saga continues! Cell Therapeutics Inc. (CTIC) plans to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma.
Pixantrone NDA transferred to newly created Division of Hematologic Products
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that it intends to appeal the U.S. Food and Drug Administration's (the "FDA") previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL"). CTI had requested accelerated approval of its NDA for this patient group for which there are no currently approved drugs. The FDA issued a Complete Response Letter to CTI related to this NDA stating, in part, that CTI should conduct an additional clinical trial prior to approval. CTI is preparing to file an appeal under the FDA's Formal Dispute Resolution process. CTI reached this decision by taking into account that CTI believes there are no approved or effective therapies for patients with relapsed or refractory aggressive NHL beyond second relapse, and that PIX 301 was the first and only randomized trial in this patient group to demonstrate significant improvement in clinically relevant endpoints including complete response rate, overall response rate, and progression free survival while being safe and effective in this indication. Full Press Release
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Showing posts with label ctic news. Show all posts
Showing posts with label ctic news. Show all posts
Tuesday, September 14, 2010
Monday, March 22, 2010
No FDA Approval For CTIC, Yet - FDA Panel Rejects Cell Therapeutics Pixantrone
Shares of Cell Therapeutics Inc (CTIC) have been halted this morning as the FDA Advistory Panel has now come out and rejected their lymphoma drug Pixantrone. When CTIC does reopen, I'd expect the stock to be cut in half atleast. CTIC still has a slight chance of approval when the FDA decision takse place at the end of April. Usually, the FDA will follow their panel ( today's vote ) but not always. With such a huge overwhelming vote, the FDA will likely to reject Pixantrone in April. Cell Therapeutics will probably need to raise more capital if it plans to continue Pixantrone.
US panel rejects Cell Therapeutics lymphoma drug
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US panel rejects Cell Therapeutics lymphoma drug
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Monday, August 24, 2009
Cell Therapeutics CTIC FDA Application Approval
August 24, 2009 - Shares of Cell Therapeutics, Inc. (CTIC) are set to open up premarket at $1.80 in about an hour as the FDA has approved the application for pixantrone for standard review. Fast Track status will be ruled on by 9/4/09. If CTIC can get fast track status, there will be an FDA approval ruling in late December. Check out my CTIC Technical Analysis
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Cell Therapeutics, Inc. (CTIC) FDA Application News
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company's New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). A Prescription Drug User Fee Act (PDUFA) date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.
"The FDA's acceptance to file our pixantrone NDA represents a significant milestone for CTI and for patients with relapsed and refractory aggressive NHL. We look forward to working with the FDA and their final decision on our request for priority review," noted James Bianco, M.D., Chief Executive Officer of CTI.
About Pixantrone
Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from currently marketed anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although anthracyclines are sufficiently effective to be used as first-line (initial) treatment, anthracyclines cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if the patient's disease returns. Pixantrone also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class. The FDA is required to set an action date for review of an application 74 days after the initial submission of the NDA. CTI expects to receive the action date for this drug candidate from the FDA and a final decision on review status on September 4th, 2009. Full Article
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Cell Therapeutics, Inc. (CTIC) FDA Application News
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company's New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). A Prescription Drug User Fee Act (PDUFA) date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.
"The FDA's acceptance to file our pixantrone NDA represents a significant milestone for CTI and for patients with relapsed and refractory aggressive NHL. We look forward to working with the FDA and their final decision on our request for priority review," noted James Bianco, M.D., Chief Executive Officer of CTI.
About Pixantrone
Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from currently marketed anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although anthracyclines are sufficiently effective to be used as first-line (initial) treatment, anthracyclines cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if the patient's disease returns. Pixantrone also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class. The FDA is required to set an action date for review of an application 74 days after the initial submission of the NDA. CTI expects to receive the action date for this drug candidate from the FDA and a final decision on review status on September 4th, 2009. Full Article
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Monday, June 1, 2009
Cell Therapeutics CTIC Stock Halted - News Pending
This afternoon, 6/1/09, Cell Therapeutics, Inc. (CTIC) stock has been halted for news pending. The company will be presenting at the ASCO conference today so i'm assuming this has something to do with the halt.
I will post the news when it hits - you can discuss CTIC at www.stockstobuy.org or view our recent discussion thread.
CTIC News - June 1, 2009
Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that at the 2009 American Society for Clinical Oncology ("ASCO") Annual Meeting for the first time since the top-line data were released, complete pivotal phase III results of CTI's EXTEND (PIX 301) clinical trial of pixantrone (the "PIX 301 EXTEND trial") in relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") were presented by Principal Investigator, Ruth Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the PIX 301 EXTEND trial who presented the study at ASCO.
"Anthracycline-related drugs can be effective salvage agents in aggressive NHL, but our use of them is limited by the significant increase in risk of cardiac failure associated with high cumulative doses of these drugs," said Dr. Pettengell. "These results represent a breakthrough in that pixantrone could extend our ability to use a highly active anthracycline-like drug in such patients and deserves to be examined in anthracycline naive patients as a potential alternative to currently available standard anthracycline drugs." Full Article
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I will post the news when it hits - you can discuss CTIC at www.stockstobuy.org or view our recent discussion thread.
CTIC News - June 1, 2009
Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that at the 2009 American Society for Clinical Oncology ("ASCO") Annual Meeting for the first time since the top-line data were released, complete pivotal phase III results of CTI's EXTEND (PIX 301) clinical trial of pixantrone (the "PIX 301 EXTEND trial") in relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") were presented by Principal Investigator, Ruth Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the PIX 301 EXTEND trial who presented the study at ASCO.
"Anthracycline-related drugs can be effective salvage agents in aggressive NHL, but our use of them is limited by the significant increase in risk of cardiac failure associated with high cumulative doses of these drugs," said Dr. Pettengell. "These results represent a breakthrough in that pixantrone could extend our ability to use a highly active anthracycline-like drug in such patients and deserves to be examined in anthracycline naive patients as a potential alternative to currently available standard anthracycline drugs." Full Article
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Monday, May 11, 2009
Cell Therapeutics (CTIC) Stock May 12, 2009
Cell Therapeutics ( CTIC ) stock is trading down in afterhours on May 11, 2009 because of two pieces of news released by the company. I actually think it's not so bad news. CTIC is selling stock at $1.25 while it was only $0.40 two weeks ago.
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CTIC Stock News - 5/12/09
Cell Therapeutics, Inc. Intends to Offer to Exchange up to $89.2 Million of its Outstanding Convertible Notes in a 'Modified Dutch Auction' Tender Offer.
Cell Therapeutics, Inc. ("CTI" or the "Company") (Nasdaq and MTA: CTIC) today announced that that its Board of Directors has authorized a "Modified Dutch Auction" tender offer (the "Exchange Offer") and that it intends to exchange shares of its common stock, no par value ("Common Stock"), and cash for up to approximately an aggregate of $89.2 million principal amount for the following outstanding shares of the Company's convertible notes (the "Notes"):
Full Article Here
Cell Therapeutics, Inc. Announces Single Institutional Investor Purchases $20 Million of Common Stock and Warrants
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) (the "Company") today announced that it has sold $20 million of shares of common stock at $1.25 per share and warrants to purchase shares of common stock in a registered offering to a single institutional investor. The Company currently expects to utilize up to $17.8 million in cash currently on hand and/or cash received in connection with this offering to pay for its anticipated tender offer to retire between $83.2 to $89.2 million of its convertible debt. The Company anticipates that the consideration for the tender offer will be in the range of $250 to $300 per $1,000 par value of the bonds.
Full Article Here
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CTIC Stock News - 5/12/09
Cell Therapeutics, Inc. Intends to Offer to Exchange up to $89.2 Million of its Outstanding Convertible Notes in a 'Modified Dutch Auction' Tender Offer.
Cell Therapeutics, Inc. ("CTI" or the "Company") (Nasdaq and MTA: CTIC) today announced that that its Board of Directors has authorized a "Modified Dutch Auction" tender offer (the "Exchange Offer") and that it intends to exchange shares of its common stock, no par value ("Common Stock"), and cash for up to approximately an aggregate of $89.2 million principal amount for the following outstanding shares of the Company's convertible notes (the "Notes"):
Full Article Here
Cell Therapeutics, Inc. Announces Single Institutional Investor Purchases $20 Million of Common Stock and Warrants
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) (the "Company") today announced that it has sold $20 million of shares of common stock at $1.25 per share and warrants to purchase shares of common stock in a registered offering to a single institutional investor. The Company currently expects to utilize up to $17.8 million in cash currently on hand and/or cash received in connection with this offering to pay for its anticipated tender offer to retire between $83.2 to $89.2 million of its convertible debt. The Company anticipates that the consideration for the tender offer will be in the range of $250 to $300 per $1,000 par value of the bonds.
Full Article Here
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Thursday, May 7, 2009
Cell Therapeutics (CTIC) Stock May 7, 2009
Cell Therapeutics ( CTIC ) reported earnings today, 5/7/09. CTIC stock is trading up in pre market: $1.59 Up 25.36%
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CTIC Stock News - 5/7/09
Cell Therapeutics Reports 76% Decrease in First Quarter 2009 Net Loss Attributable to Common Shareholders; Completion of Pixantrone NDA Submission on Track for Second Quarter 2009
Pixantrone Named-Patient Program Initiated in Europe
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reported recent accomplishments and financial results for the quarter ended March 31, 2009.
"Our focus for the first half of 2009 was to initiate and complete the NDA submission for pixantrone while we implemented final steps in our cost cutting efforts and raised much needed operating capital on the least dilutive terms possible -- all while cleaning up the Company's capital structure," said James A. Bianco, M.D., CEO of CTI. "We are pleased with our results as reflected in our first quarter financials. We have cut our net operating losses attributable to common shareholders by 76%, raised gross proceeds of $44.3 million in 2009 and eliminated all of our outstanding preferred stock, while staying on track to complete the NDA submission for pixantrone in June 2009."
Total net operating expenses decreased $21.8 million, or 77%, to $6.6 million for the quarter ended March 31, 2009 compared to $28.4 million for the same period in 2008 as a result of a $10.2 million one-time gain on the sale CTI's investment in the Zevalin joint venture coupled with a decrease in research and development expenses. Excluding the one-time gain, total net operating expenses decreased 41% over the same period last year. Research and development expenses decreased 7.9 million, or 50%, to $8.0 million for the current quarter compared to $15.9 million for the same period in 2008 as the result of cost reduction initiatives and expenses related to our clinical trial programs. Net loss attributable to common shareholders decreased $41.5 million, or 76%, to $13.1 million ($0.05 per share) for the quarter ended March 31, 2009, compared to $54.6 million ($7.68 per share) for the comparable period in 2008. The reduction in net loss per share is primarily due to an increase in the number of shares outstanding, reduction of expenses and gain on sale of CTI's investment in the Zevalin joint venture.
Full Article
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CTIC Stock News - 5/7/09
Cell Therapeutics Reports 76% Decrease in First Quarter 2009 Net Loss Attributable to Common Shareholders; Completion of Pixantrone NDA Submission on Track for Second Quarter 2009
Pixantrone Named-Patient Program Initiated in Europe
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reported recent accomplishments and financial results for the quarter ended March 31, 2009.
"Our focus for the first half of 2009 was to initiate and complete the NDA submission for pixantrone while we implemented final steps in our cost cutting efforts and raised much needed operating capital on the least dilutive terms possible -- all while cleaning up the Company's capital structure," said James A. Bianco, M.D., CEO of CTI. "We are pleased with our results as reflected in our first quarter financials. We have cut our net operating losses attributable to common shareholders by 76%, raised gross proceeds of $44.3 million in 2009 and eliminated all of our outstanding preferred stock, while staying on track to complete the NDA submission for pixantrone in June 2009."
Total net operating expenses decreased $21.8 million, or 77%, to $6.6 million for the quarter ended March 31, 2009 compared to $28.4 million for the same period in 2008 as a result of a $10.2 million one-time gain on the sale CTI's investment in the Zevalin joint venture coupled with a decrease in research and development expenses. Excluding the one-time gain, total net operating expenses decreased 41% over the same period last year. Research and development expenses decreased 7.9 million, or 50%, to $8.0 million for the current quarter compared to $15.9 million for the same period in 2008 as the result of cost reduction initiatives and expenses related to our clinical trial programs. Net loss attributable to common shareholders decreased $41.5 million, or 76%, to $13.1 million ($0.05 per share) for the quarter ended March 31, 2009, compared to $54.6 million ($7.68 per share) for the comparable period in 2008. The reduction in net loss per share is primarily due to an increase in the number of shares outstanding, reduction of expenses and gain on sale of CTI's investment in the Zevalin joint venture.
Full Article
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Wednesday, May 6, 2009
Cell Therapeutics (CTIC) Stock May 6, 2009
After reporting positive news yesterday, Cell Therapeutics (CTIC) was out with more news after the close last night. CTIC Stock Forum - www.stockstobuy.org
CTIC Stock News - 5/6/09
Cell Therapeutics, Inc. (CTI) to Report 2009 First Quarter Financial Results on May 7
On Thursday, May 7, 2009, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of Cell Therapeutics, Inc.'s (CTI) (Nasdaq and MTA: CTIC) management team will host a conference call to discuss the Company's 2009 first quarter achievements and financial results.
Live audio webcast at http://www.celltherapeutics.com will be archived for post listening approximately two hours after call ends
Cell Therapeutics (CTIC) Technical Analysis
CTIC stock closed over $0.49 on Tuesday. There is no resistance until the 200 day moving average at $0.79. A close over the 200 DMA would set up some kind of retest of $0.97. I like pullbacks into the $0.40's.
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CTIC Stock News - 5/6/09
Cell Therapeutics, Inc. (CTI) to Report 2009 First Quarter Financial Results on May 7
On Thursday, May 7, 2009, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of Cell Therapeutics, Inc.'s (CTI) (Nasdaq and MTA: CTIC) management team will host a conference call to discuss the Company's 2009 first quarter achievements and financial results.
Live audio webcast at http://www.celltherapeutics.com will be archived for post listening approximately two hours after call ends
Cell Therapeutics (CTIC) Technical Analysis
CTIC stock closed over $0.49 on Tuesday. There is no resistance until the 200 day moving average at $0.79. A close over the 200 DMA would set up some kind of retest of $0.97. I like pullbacks into the $0.40's.
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Tuesday, May 5, 2009
Cell Therapeutics (CTIC) Stock May 5, 2009
This morning, 5/5/09, Cell Therapeutics, Inc. (CTIC) released news regarding one of their drugs. In pre market trading, CTIC shares are up 19% to $0.56 and breaking out.
CTIC News - 5/5/09
CTIC Stock Forum - www.stockstobuy.org
Pixantrone Now Available in Europe on a Named-Patient Basis
--Cell Therapeutics and IDIS Partner to Accelerate Patient Access to Pixantrone through Program
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today announced that pixantrone is now available on a named-patient basis in Europe. Pixantrone will be supplied by IDIS to healthcare professionals for the treatment of individual patients with aggressive non-Hodgkin's lymphoma (NHL) that has either relapsed after standard therapies or is refractory to them. We know of no therapy that has previously been shown to be effective treatment for such patients.
"CTI has worked hard to make pixantrone available in Europe at the prescriber's request as it provides an option for these difficult to treat aggressive NHL patients," noted Craig Philips, President of CTI. "We continue to work toward potential approval of pixantrone at the end of 2009 in the United States and expect to complete the submission of the New Drug Application to the Food & Drug Administration this quarter." Full Article
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CTIC News - 5/5/09
CTIC Stock Forum - www.stockstobuy.org
Pixantrone Now Available in Europe on a Named-Patient Basis
--Cell Therapeutics and IDIS Partner to Accelerate Patient Access to Pixantrone through Program
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today announced that pixantrone is now available on a named-patient basis in Europe. Pixantrone will be supplied by IDIS to healthcare professionals for the treatment of individual patients with aggressive non-Hodgkin's lymphoma (NHL) that has either relapsed after standard therapies or is refractory to them. We know of no therapy that has previously been shown to be effective treatment for such patients.
"CTI has worked hard to make pixantrone available in Europe at the prescriber's request as it provides an option for these difficult to treat aggressive NHL patients," noted Craig Philips, President of CTI. "We continue to work toward potential approval of pixantrone at the end of 2009 in the United States and expect to complete the submission of the New Drug Application to the Food & Drug Administration this quarter." Full Article
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