AI
Wednesday, January 11, 2012 11:13:51 AM
CHartcheck TLON and DD:
holding all shares for May last ride was before FDA decission from 2009 -2010 from 40 cent to 4$
80 cent is the key to break to get to 1$ ++
DD on Tlon
DD Board:
from fillings:
sponsord Phase 1
Additionally, in July 2011, the National Cancer Institute enrolled the first patient in an open-label Phase 1 dose-escalation trial of Marqibo in children and adolescents with solid tumors and hematologic malignancies, including ALL, being conducted at the National Cancer Institute in Bethesda, MD. The primary objective of this Phase I clinical trial, which is an investigator-sponsored study, is to determine the maximum tolerated dose.
Menadione Topical Lotion (MTL) sponsord Phase 2
is a novel cancer supportive care product candidate, being developed for the prevention and/or treatment of the skin toxicities associated with the use of epidermal growth factor receptor inhibitors, a type of anti-cancer agent used in the treatment of certain cancers. In August 2011, we announced that we have entered into an agreement with the Mayo Clinic pursuant to which the Mayo Clinic will sponsor a randomized Phase 2 clinical trial of MTL in patients taking biologic and small molecule EGFR inhibitors for anti-cancer therapy and will test the effectiveness of MTL in preventing skin toxicities associated with EGFR inhibitors.
ANNOUNCEMENT TLON
Talon Therapeutics Announces $11M Financing
SAN MATEO, Calif., Jan. 9, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics Inc., (OTCBB:TLON), today announced that it has entered into an Investment Agreement with Warburg Pincus and Deerfield Management, its largest 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 $60M in preferred stock within one year following an accelerated approval of Marqibo.
"We are pleased Warburg Pincus and Deerfield continue to support the Company's initiatives. This $11 million will primarily fund our efforts to obtain FDA approval for Marqibo, which has a PDUFA date of May 13, 2012. The potential for subsequent cash infusions from this financing will support the launch of Marqibo in the U.S. and Marqibo's two ongoing Phase 3 programs," said Steven R. Deitcher, M.D., President and Chief Executive Officer and Board Member of Talon Therapeutics.
Terms of the Financing
On January 9, 2012, the Company entered into an Investment Agreement for the sale of up to $71 million of Preferred Stock, and closed on the sale of 110,000 shares of Series A-2 Preferred Stock ($11 million), at a per share sale price of $100. The Series A-2 Preferred Stock is convertible into shares of the Company's common stock at an initial conversion price of $0.30, subject to customary adjustments. From the date of the Investment Agreement until the first anniversary of the Company's receipt of marketing approval from the FDA for Marqibo, the investors have the right to invest up to an additional $60 million in Series A-3 Preferred Stock, which is initially convertible into common stock at a conversion price of $0.35, subject to customary adjustments. Upon issuance, the Series A-2 and A-3 Preferred Stock will accrete at 9% per annum, among other provisions.
In June 2010, the Company had previously entered into an investment agreement with Warburg Pincus and Deerfield Management that provided for a financing of up to $100 million in preferred stock. Of such total, $40 million was invested at a conversion price of $0.736. Effective with the completion of this new financing, the unused $60 million in available options from the June 2010 financing have been terminated.
Roth Capital Partners, LLC served as financial advisor to a special committee of Talon's board of directors and provided a fairness opinion in connection with the transaction.
from yahoo board posted by brick
On December 14, 2011, the Board of Directors (the “Board”) of Talon Therapeutics, Inc. (the “Company”) appointed Cecilia Gonzalo as a director of the Company. Ms. Gonzalo was also appointed to serve as a member of the Board’s Compensation and Nominating & Corporate Governance Committees. As a non-employee director of the Company, Ms. Gonzalo will receive the standard compensation applicable to the Company’s non-employee directors, the terms of which are described in the Company’s Registration Statement on Form S-1 filed on May 5,
2011.
Ms. Gonzalo, age 37, is a Managing Director at Warburg Pincus LLC and a General Partner of Warburg Pincus & Co., where she
focuses on healthcare investments in the biotechnology, pharmaceuticals and healthcare services sectors. Prior to joining Warburg Pincus in 2001, Ms. Gonzalo worked at Goldman Sachs in the Investment Banking Division focusing on corporate finance and mergers and acquisitions transactions in Latin America, as well as in the Principal Investment Area focusing on investments in the region. Ms. Gonzalo received a B.A., cumlaude, in Biochemical Sciences from Harvard College and an M.B.A. from Harvard Business School. Ms. Gonzalo also serves as a director of LaVie Care Centers (formerly known as Florida Healthcare Properties) and Rib-X Pharmaceuticals. There are no family relationships between Ms. Gonzalo and any other member of the Board or any executive officer of the Company.
Effective as of the appointment of Ms. Gonzalo as a director, Nishan de Silva resigned from the Board.
As previously disclosed in the Company’s Current Report on Form 8-K filed on June 11, 2010, pursuant to the terms of the Investment Agreement dated June 7, 2010, entered into among the Company and Warburg Pincus Private Equity X, L.P. and Warburg Pincus X Partners, L.P. (together, “Warburg Pincus”), Warburg Pincus has the right to designate five of nine members of the Board. As also previously disclosed in such report and in the Company’s Current Report on Form 8-K filed on August 5, 2010, Warburg Pincus previously designated Jonathan Leff, Andrew Ferrer, Robert J. Spiegel and Dr. de Silva for appointment. Following the appointment of Ms. Gonzalo, who was designated for
appointment by Warburg Pincus, and the resignation of Dr. de Silva, Warburg Pincus has the right to designate one additional person for appointment to the Board.
Accelerated approval review path confirmed by the FDA
Prescription Drug User Fee Act (PDUFA) date set for May 13, 2012
alon Therapeutics, Inc. (OTCBB:TLON) announced 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.
"Two important hurdles have been crossed with the acceptance for filing of the Marqibo NDA and affirmation of the accelerated approval review path. We remain 100% focused on our goal of an FDA approval of Marqibo," stated Steven R. Deitcher, President, Chief Executive Officer and Board Member of Talon Therapeutics. "The patients we are seeking to treat represent a rare hematologic malignancy and have a grave prognosis. The accelerated approval path has the potential to provide access to a new, well-tolerated, and effective treatment more quickly for these patients. We aim to initiate and commence enrollment in the Phase 3 confirmatory trial, that recently received an SPA, prior to the May PDUFA date," Dr. Deitcher added.
In August 2011, Talon received Special Protocol Assessment (SPA) agreement from the FDA for its proposed Phase 3 confirmatory study, named HALLMARQ, for the treatment of adults = 60 years old with newly diagnosed ALL. In addition to the Phase 3 adult, front-line ALL study, Talon is developing Marqibo for pediatric cancers (solid tumors and hematologic malignancies) in a Phase 1-2 clinical study conducted by the National Cancer Institute and for newly diagnosed aggressive Non-Hodgkin's Lymphoma to be conducted by the German High Grade Non-Hodgkin's Lymphoma Study Group.
About Marqibo
Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon has been primarily developing Marqibo for the treatment of adult, Ph- ALL. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.
About Talon Therapeutics
Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees.
In addition to Marqibo, the Company has additional pipeline opportunities some of which, like Marqibo, have the potential to improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
Additional information on Talon Therapeutics can be found at http://www.talontx.com/
The Talon Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
and some more drugs to come
pipline now
PIPELINE from 25.01.2010 posted by tocan :
hana is now TLON
Best
baggers
holding all shares for May last ride was before FDA decission from 2009 -2010 from 40 cent to 4$
80 cent is the key to break to get to 1$ ++
DD on Tlon
DD Board:
from fillings:
sponsord Phase 1
Additionally, in July 2011, the National Cancer Institute enrolled the first patient in an open-label Phase 1 dose-escalation trial of Marqibo in children and adolescents with solid tumors and hematologic malignancies, including ALL, being conducted at the National Cancer Institute in Bethesda, MD. The primary objective of this Phase I clinical trial, which is an investigator-sponsored study, is to determine the maximum tolerated dose.
Menadione Topical Lotion (MTL) sponsord Phase 2
is a novel cancer supportive care product candidate, being developed for the prevention and/or treatment of the skin toxicities associated with the use of epidermal growth factor receptor inhibitors, a type of anti-cancer agent used in the treatment of certain cancers. In August 2011, we announced that we have entered into an agreement with the Mayo Clinic pursuant to which the Mayo Clinic will sponsor a randomized Phase 2 clinical trial of MTL in patients taking biologic and small molecule EGFR inhibitors for anti-cancer therapy and will test the effectiveness of MTL in preventing skin toxicities associated with EGFR inhibitors.
ANNOUNCEMENT TLON
Talon Therapeutics Announces $11M Financing
SAN MATEO, Calif., Jan. 9, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics Inc., (OTCBB:TLON), today announced that it has entered into an Investment Agreement with Warburg Pincus and Deerfield Management, its largest 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 $60M in preferred stock within one year following an accelerated approval of Marqibo.
"We are pleased Warburg Pincus and Deerfield continue to support the Company's initiatives. This $11 million will primarily fund our efforts to obtain FDA approval for Marqibo, which has a PDUFA date of May 13, 2012. The potential for subsequent cash infusions from this financing will support the launch of Marqibo in the U.S. and Marqibo's two ongoing Phase 3 programs," said Steven R. Deitcher, M.D., President and Chief Executive Officer and Board Member of Talon Therapeutics.
Terms of the Financing
On January 9, 2012, the Company entered into an Investment Agreement for the sale of up to $71 million of Preferred Stock, and closed on the sale of 110,000 shares of Series A-2 Preferred Stock ($11 million), at a per share sale price of $100. The Series A-2 Preferred Stock is convertible into shares of the Company's common stock at an initial conversion price of $0.30, subject to customary adjustments. From the date of the Investment Agreement until the first anniversary of the Company's receipt of marketing approval from the FDA for Marqibo, the investors have the right to invest up to an additional $60 million in Series A-3 Preferred Stock, which is initially convertible into common stock at a conversion price of $0.35, subject to customary adjustments. Upon issuance, the Series A-2 and A-3 Preferred Stock will accrete at 9% per annum, among other provisions.
In June 2010, the Company had previously entered into an investment agreement with Warburg Pincus and Deerfield Management that provided for a financing of up to $100 million in preferred stock. Of such total, $40 million was invested at a conversion price of $0.736. Effective with the completion of this new financing, the unused $60 million in available options from the June 2010 financing have been terminated.
Roth Capital Partners, LLC served as financial advisor to a special committee of Talon's board of directors and provided a fairness opinion in connection with the transaction.
from yahoo board posted by brick
On December 14, 2011, the Board of Directors (the “Board”) of Talon Therapeutics, Inc. (the “Company”) appointed Cecilia Gonzalo as a director of the Company. Ms. Gonzalo was also appointed to serve as a member of the Board’s Compensation and Nominating & Corporate Governance Committees. As a non-employee director of the Company, Ms. Gonzalo will receive the standard compensation applicable to the Company’s non-employee directors, the terms of which are described in the Company’s Registration Statement on Form S-1 filed on May 5,
2011.
Ms. Gonzalo, age 37, is a Managing Director at Warburg Pincus LLC and a General Partner of Warburg Pincus & Co., where she
focuses on healthcare investments in the biotechnology, pharmaceuticals and healthcare services sectors. Prior to joining Warburg Pincus in 2001, Ms. Gonzalo worked at Goldman Sachs in the Investment Banking Division focusing on corporate finance and mergers and acquisitions transactions in Latin America, as well as in the Principal Investment Area focusing on investments in the region. Ms. Gonzalo received a B.A., cumlaude, in Biochemical Sciences from Harvard College and an M.B.A. from Harvard Business School. Ms. Gonzalo also serves as a director of LaVie Care Centers (formerly known as Florida Healthcare Properties) and Rib-X Pharmaceuticals. There are no family relationships between Ms. Gonzalo and any other member of the Board or any executive officer of the Company.
Effective as of the appointment of Ms. Gonzalo as a director, Nishan de Silva resigned from the Board.
As previously disclosed in the Company’s Current Report on Form 8-K filed on June 11, 2010, pursuant to the terms of the Investment Agreement dated June 7, 2010, entered into among the Company and Warburg Pincus Private Equity X, L.P. and Warburg Pincus X Partners, L.P. (together, “Warburg Pincus”), Warburg Pincus has the right to designate five of nine members of the Board. As also previously disclosed in such report and in the Company’s Current Report on Form 8-K filed on August 5, 2010, Warburg Pincus previously designated Jonathan Leff, Andrew Ferrer, Robert J. Spiegel and Dr. de Silva for appointment. Following the appointment of Ms. Gonzalo, who was designated for
appointment by Warburg Pincus, and the resignation of Dr. de Silva, Warburg Pincus has the right to designate one additional person for appointment to the Board.
Accelerated approval review path confirmed by the FDA
Prescription Drug User Fee Act (PDUFA) date set for May 13, 2012
alon Therapeutics, Inc. (OTCBB:TLON) announced 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.
"Two important hurdles have been crossed with the acceptance for filing of the Marqibo NDA and affirmation of the accelerated approval review path. We remain 100% focused on our goal of an FDA approval of Marqibo," stated Steven R. Deitcher, President, Chief Executive Officer and Board Member of Talon Therapeutics. "The patients we are seeking to treat represent a rare hematologic malignancy and have a grave prognosis. The accelerated approval path has the potential to provide access to a new, well-tolerated, and effective treatment more quickly for these patients. We aim to initiate and commence enrollment in the Phase 3 confirmatory trial, that recently received an SPA, prior to the May PDUFA date," Dr. Deitcher added.
In August 2011, Talon received Special Protocol Assessment (SPA) agreement from the FDA for its proposed Phase 3 confirmatory study, named HALLMARQ, for the treatment of adults = 60 years old with newly diagnosed ALL. In addition to the Phase 3 adult, front-line ALL study, Talon is developing Marqibo for pediatric cancers (solid tumors and hematologic malignancies) in a Phase 1-2 clinical study conducted by the National Cancer Institute and for newly diagnosed aggressive Non-Hodgkin's Lymphoma to be conducted by the German High Grade Non-Hodgkin's Lymphoma Study Group.
About Marqibo
Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon has been primarily developing Marqibo for the treatment of adult, Ph- ALL. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.
About Talon Therapeutics
Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees.
In addition to Marqibo, the Company has additional pipeline opportunities some of which, like Marqibo, have the potential to improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
Additional information on Talon Therapeutics can be found at http://www.talontx.com/
The Talon Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
and some more drugs to come
pipline now
PIPELINE from 25.01.2010 posted by tocan :
hana is now TLON
Best
baggers
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