Apr. 29, 2014, 9:12 AM
Mar. 4, 2014, 4:49 PM
- Cell Therapeutics (CTIC) Q4 revenue balloons to $32.9M versus $0 a year ago. Almost all of the revenue is due to Baxter's (BAX) upfront payment of $32.4M for the license to develop and commercialize pacritinib.
- Product revenues for Q4 and FY13 were $.5M and $2.3M, respectively.
- Net income for the quarter was $10.2M ($.08/share) due to the Baxter payment. Net loss for the year was $49.6M ($.43/share).
- FY14 guidance projects a loss from operations of $45M - $50M.
- Consensus estimate for Q1 is a loss of $.23/share on revenues of $1.3M.
- Consensus estimate for 2014 is a loss of $.48/share on revenues of $23.9M.
- Mutual fund ownership has increased from 30 to 85 the past 4 quarters.
Feb. 27, 2014, 9:47 AM
- U.K. health-cost regulator NICE has given a final recommendation for the use of Cell Therapeutics' (CTIC) Pixuvri for treating advanced B-cell non-Hodgkin lymphoma.
- Cell Therapeutics now hopes that NHS commissioners "will recognize the lack of suitable treatment options that exist for patients at this stage of the disease and list Pixuvri on hospital formularies as soon as possible."
- Cell Therapeutics expects to launch Pixuvri in England and Wales in the spring.
- Shares are +8.3%. (PR)
Feb. 27, 2014, 9:09 AM
Feb. 7, 2014, 12:46 PM
Feb. 3, 2014, 9:09 AM
Jan. 28, 2014, 9:10 AM
Jan. 27, 2014, 12:46 PM
Jan. 21, 2014, 9:10 AM
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Jan. 14, 2014, 8:25 AM
- Cell Therapeutics (CTIC) rises 3.4% premarket after giving a corporate update.
- Pacritinib: Top-line data from Phase 3 in myelofibrosis in H2, a second Phase 3 trial is "expected to begin enrollment imminently."
- Pixuvri: Company expects to complete enrollment in Phase 3 post-marketing commitment study in relapsed B-cell non-Hodgkin lymphoma in 2015 (endpoint changed to PFS from OS).
- Tosedostat: Investigator-sponsored trials to resume in Q1.
- The company says "up-front payment and anticipated near-term milestones related to the Baxter collaboration will potentially allow CTI to reach regulatory submissions for pacritinib without requiring additional equity financing to fund such activities." (PR)
Jan. 13, 2014, 9:12 AM
Jan. 13, 2014, 8:23 AM
- Cell Therapeutics (CTIC) will reacquire the rights to Pixuvri and Opaxio from Novartis (NVS) on the condition that NVS receive "certain potential payments ... based on sales [and] any sublicens[ing]."
- "Regaining full rights to these two anti-cancer agents ... provides us with the flexibility to manage these assets within the context of our overall product portfolio strategy," CTIC CEO James Bianco says. (PR)
- Recently: CTiC rallies on NICE nod for Pixuvri
- CTIC +12% premarket
Jan. 6, 2014, 12:45 PM
Jan. 6, 2014, 9:02 AM
- Cell Therapeutics (CTIC) rises 3% premarket.
- U.K. cost gatekeeper NICE has issued a positive final draft opinion on Pixuvri.
- The regulator "recommends funding the treatment as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma," the company says.
- Here's CEO James Bianco: "[This] means that physicians in England and Wales now have access to the only approved therapy for their patients with aggressive B-cell NHL in the third- and fourth-line salvage setting." (PR)
Jan. 2, 2014, 7:04 AM
- The FDA has lifted a partial clinical hold on Cell Therapeutics' (CTIC +3.1%) Tosedostat blood cancer drug.
- The agency placed the hold in June following the death of a patient in a trial in which the treatment was given along with chemotherapy.
- Tosedostat is in Phase II trials in elderly patients with newly diagnosed and relapsed acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). (PR)
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