Key Developments: Talon Therapeutics Inc (TLON.OB)

TLON.OB on OTC BB

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17 May 2013
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Latest Key Developments (Source: Significant Developments)

Talon Therapeutics Inc Announces Review Of Strategic Alternatives
Monday, 7 Jan 2013 09:02am EST 

Talon Therapeutics Inc announced that the Board has authorized a review of strategic alternatives. Goldman Sachs has been engaged to provide financial advisory services. The review of strategic alternatives may lead to a possible transaction, including the merger, business combination, or sale of the Company. No decision has been made to enter into a transaction at this time, and there can be no assurance that Talon will enter into a transaction in the future. The Company does not plan to disclose or comment on developments regarding the strategic review process until further disclosure is deemed appropriate.  Full Article

Talon Therapeutics, Inc. Receives Notification Of Three Month PDUFA Date Extension For Marqibo
Monday, 7 May 2012 09:00am EDT 

Talon Therapeutics, Inc. announced that it has been informed by the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) seeking accelerated approval of Marqibo has been given a three-month Prescription Drug User Fee Act (PDUFA) date extension to August 12, 2012. Marqibo is a targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon is primarily developing Marqibo for the treatment of Ph- adult ALL. Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the FDA. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency. In addition to the Phase III confirmatory study of Marqibo in front-line adult elderly ALL, Marqibo is being evaluated in an on-going Phase III trial in front-line adult elderly aggressive non-Hodgkin's lymphoma conducted by the German High Grade Non-Hodgkin's Lymphoma Study group, and in a Phase I trial in pediatric cancers, including ALL, being conducted by the National Cancer Institute. A phase II trial of Marqibo in front-line adult ALL to be conducted by the M.D. Anderson Cancer Center is expected to begin enrolling in the third quarter of 2012.  Full Article

Talon Therapeutics, Inc. Announces $11 Million Financing
Monday, 9 Jan 2012 12:43pm EST 

Talon Therapeutics, Inc. announced that it has entered into an Investment Agreement with Warburg Pincus and Deerfield Management, its shareholders, for the sale of $11 million in preferred stock. Talon intends to use the net proceeds from the financing to advance its clinical development and regulatory activities for Marqibo, and for general corporate purposes. The Investment Agreement provides an option for the investors to purchase up to an additional $60 million in preferred stock within one year following an accelerated approval of Marqibo.  Full Article

Talon Therapeutics, Inc. Announces New Drug Application for Marqibo Accepted For Filing By United States Food And Drug Administration
Tuesday, 27 Sep 2011 09:01am EDT 

Talon Therapeutics, Inc. announced that its new drug application (NDA) seeking accelerated approval of Marqibo (vincristine sulfate liposomes injection) has been accepted for filing by the FDA. Marqibo will be reviewed by the FDA under Subpart H -- Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses, for the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy.  Full Article

Talon Therapeutics, Inc. Submits New Drug Application For Marqibo
Monday, 18 Jul 2011 09:00am EDT 

Talon Therapeutics, Inc. announced that its New Drug Application (NDA) for Marqibo (vincristine sulfate liposomes injection) was submitted to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of Marqibo in adult Ph- ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy.  Full Article

Talon Therapeutics, Inc Presents Marqibo Hematopoietic Stem Cell Transplantation (HSCT) Bridging Data
Monday, 6 Jun 2011 09:00am EDT 

Talon Therapeutics, Inc announced the presentation of a poster titled VSLI (vincristine sulfate liposomes injection, Marqibo) Bridging to Potentially Curative Hematopoietic Stem Cell Transplantation (HSCT) in Adults with Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL). In a Phase 2, multi-national study, 65 adults with Ph- ALL in second or greater relapse or who had progressed after two or more prior lines of treatment received single-agent Marqibo 2.25 mg/m2 (without dose cap) IV weekly. Overall response rate (physician assessment) was 35.4% with a 20% complete response (CR) plus CR with incomplete hematologic recovery (CRi) rate. VSLI, despite delivering individual (2.8-5.5 mg) and cumulative (up to 70.1 mg) dose-intense VCR, had a similar safety profile to that reported for standard VCR. VSLI enabled bridging to HSCT in 12 of 65 (18.5%) subjects. Eight of the 12 (66.7%) subjects had undergone at least one pre-VSLI HSCT. Five of the 12 subjects were in CR/CRi at the time of post-VSLI HSCT. VSLI produced rapid CR/CRi or disease stabilization and a meaningful bridge to HSCT in 12 or 65 (18.5%) heavily pre-treated near end-stage adults with ALL. Long-term survival (greater than 12 months) was achieved in 27% of those able to receive post-VSLI HSCT. These unexpected outcomes that are important to patients may reflect the effectiveness of the dose intensification facilitated by VSLI compared to that provided by standard vincristine.  Full Article

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