Positive Findings, Collaborations, and NDA Filings
Post# of 29735
Posted On: 06/06/2013 9:30:57 AM
Positive Findings, Collaborations, and NDA Filings Strengthen Pipelines - Research Report on Clovis Oncology, MannKind, TESAR...
NEW YORK, June 6, 2013 /PRNewswire/ --
Editor Note: For more information about this release, please scroll to bottom.
Today, Wall Street Reports announced new research reports highlighting Clovis Oncology Inc. (NASDAQ: CLVS), MannKind Corporation (NASDAQ: MNKD), TESARO Inc. (NASDAQ: TSRO), Peregrine Pharmaceuticals (NASDAQ: PPHM), and Vanda Pharmaceuticals Inc. (NASDAQ: VNDA). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
Clovis Oncology Inc. Research Report
On June 3, 2013, Clovis Oncology Inc. (Clovis Oncology) announced initial findings from the Phase I portion of its ongoing Phase I/II clinical study of CO-1686, the novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer (NSCLC) in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M. According to the Company, three of four evaluable T790M patients treated at 900mg BID (twice-daily) achieved partial responses. Further, it reported that CO-1686 appeared well-tolerated, with no evidence of wild-type EGFR inhibition. Dr. Lecia V. Sequist of the Massachusetts General Hospital Cancer Center and Associate Professor of Medicine at Harvard Medical School, Boston, said, "It has been exciting and quite hopeful to observe that patients are responding to CO-1686 and that the side effect profile has been so mild. A drug that works effectively for EGFR acquired resistance would be welcomed by the lung cancer community." The Full Research Report on Clovis Oncology Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/6b27_CLVS]
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MannKind Corporation Research Report
On May 31, 2013, MannKind Corporation (MannKind) announced that all follow-up visits have been completed for patients enrolled in Study 171, a Phase 3 clinical study of AFREZZA (insulin human [rDNA origin]) inhalation powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using the Company's next-generation inhaler. Study 171 is an open-label study in patients with type 1 diabetes. After a run-in period, during which all patients were optimized on their basal insulin regimen, 518 subjects were randomized to one of three arms for mealtime insulin: a control arm, in which patients utilize rapid-acting insulin, or one of two AFREZZA arms, one for the MedTone inhaler and the other for the next-generation inhaler. After the mealtime insulin was titrated, there was a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels, which is the primary outcome parameter. The Company expects to release data from this study in the summer of 2013. The Full Research Report on MannKind Corporation - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/0b44_MNKD]
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TESARO Inc. Research Report
On June 3, 2013, TESARO, Inc. (TESARO), Breast International Group (BIG), a non-profit organization for academic breast cancer research groups from around the world, and the European Organization for Research and Treatment of Cancer (EORTC), an international, independent, multidisciplinary non-profit research organization, announced a partnership for the Phase 3 clinical development of niraparib, an orally active, potent poly (ADP-ribose) polymerase (PARP) inhibitor. TESARO, BIG and EORTC will use BIG's and EORTC's scientific and clinical expertise and network of collaborative groups and their associated hospitals and oncology research centers to accelerate the completion of the Phase 3 clinical trial of niraparib in patients with breast cancer. The primary endpoint of this trial is progression free survival (PFS), with overall survival (OS) as a secondary endpoint. TESARO expects to open this study to patients during the second half of 2013. The Full Research Report on TESARO Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/4f59_TSRO]
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Peregrine Pharmaceuticals Research Report
On June 3, 2013, Peregrine Pharmaceuticals, Inc. (Peregrine Pharmaceuticals) reported that data was presented at the 2013 ASCO (American Society of Clinical Oncology) Meeting from two clinical trials evaluating the Company's lead clinical candidate bavituximab, a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. Interim data from a Phase I trial, evaluating bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer (MBC), showed that 85% of patients were able to achieve objective tumor response, with 15% of patients achieving a complete response (CR) in accordance to Response Evaluation Criteria in Solid Tumors (RECIST). Further, the Company reported that in the second study, results from a randomized Phase II trial of bavituximab plus gemcitabine in patients with non-resectable Stage IV pancreatic cancer demonstrated more than a doubling of the overall response rate (ORR) and an improvement in overall survival (OS), including a delayed separation in the Kaplan-Maeier survival curve that is commonly seen in promising cancer immunotherapies. The Full Research Report on Peregrine Pharmaceuticals - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/df4a_PPHM]
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Vanda Pharmaceuticals Inc. Research Report
On May 31, 2013, Vanda Pharmaceuticals Inc. (Vanda Pharmaceuticals) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tasimelteon, a circadian regulator in development for the treatment of non-24 hour disorder (Non-24) in the totally blind. Non-24 is a serious and rare, circadian rhythm disorder that affects the majority of totally blind individuals who lack light perception and, therefore, cannot synchronize their master body clock to the 24-hour day. There are currently no FDA approved products for the treatment of Non-24. The Full Research Report on Vanda Pharmaceuticals Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/b7a8_VNDA]
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EDITOR NOTES:
This is not company news. We are an independent source and our views do not reflect the companies mentioned.
Information in this release is fact checked and produced on a best efforts basis and reviewed by a CFA. However, we are only human and are prone to make mistakes. If you notice any errors or omissions, please notify us below.
This information is submitted as a net-positive to companies mentioned, to increase awareness for mentioned companies to our subscriber base and the investing public.
If you wish to have your company covered in more detail by our team, or wish to learn more about our services, please contact us at pubco@EquityNewsNetwork.com.
For any urgent concerns or inquires, please contact us at compliance@EquityNewsNetwork.com.
Are you a public company? Would you like to see similar coverage on your company? Send us a full investors' package to research@EquityNewsNetwork.com for consideration.
COMPLIANCE PROCEDURE
Content is researched, written and reviewed on a best-effort basis. This document, article or report is prepared and authored by Equity News Network. An outsourced research services provider has, through Chartered Financial Analysts, only reviewed the information provided by Equity News Network in this article or report according to the Procedures outlined by Equity News Network. Equity News Network is not entitled to veto or interfere in the application of such procedures by the outsourced provider to the articles, documents or reports, as the case may be.
NOT FINANCIAL ADVICE
Equity News Network makes no warranty, expressed or implied, as to the accuracy or completeness or fitness for a purpose (investment or otherwise), of the information provided in this document. This information is not to be construed as personal financial advice. Readers are encouraged to consult their personal financial advisor before making any decisions to buy, sell or hold any securities mentioned herein.
NO WARRANTY OR LIABILITY ASSUMED
Equity News Network is not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted by Equity News Network whatsoever for any direct, indirect or consequential loss arising from the use of this document. Equity News Network expressly disclaims any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Equity News Network does not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.
NEW YORK, June 6, 2013 /PRNewswire/ --
Editor Note: For more information about this release, please scroll to bottom.
Today, Wall Street Reports announced new research reports highlighting Clovis Oncology Inc. (NASDAQ: CLVS), MannKind Corporation (NASDAQ: MNKD), TESARO Inc. (NASDAQ: TSRO), Peregrine Pharmaceuticals (NASDAQ: PPHM), and Vanda Pharmaceuticals Inc. (NASDAQ: VNDA). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
Clovis Oncology Inc. Research Report
On June 3, 2013, Clovis Oncology Inc. (Clovis Oncology) announced initial findings from the Phase I portion of its ongoing Phase I/II clinical study of CO-1686, the novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer (NSCLC) in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M. According to the Company, three of four evaluable T790M patients treated at 900mg BID (twice-daily) achieved partial responses. Further, it reported that CO-1686 appeared well-tolerated, with no evidence of wild-type EGFR inhibition. Dr. Lecia V. Sequist of the Massachusetts General Hospital Cancer Center and Associate Professor of Medicine at Harvard Medical School, Boston, said, "It has been exciting and quite hopeful to observe that patients are responding to CO-1686 and that the side effect profile has been so mild. A drug that works effectively for EGFR acquired resistance would be welcomed by the lung cancer community." The Full Research Report on Clovis Oncology Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/6b27_CLVS]
--
MannKind Corporation Research Report
On May 31, 2013, MannKind Corporation (MannKind) announced that all follow-up visits have been completed for patients enrolled in Study 171, a Phase 3 clinical study of AFREZZA (insulin human [rDNA origin]) inhalation powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using the Company's next-generation inhaler. Study 171 is an open-label study in patients with type 1 diabetes. After a run-in period, during which all patients were optimized on their basal insulin regimen, 518 subjects were randomized to one of three arms for mealtime insulin: a control arm, in which patients utilize rapid-acting insulin, or one of two AFREZZA arms, one for the MedTone inhaler and the other for the next-generation inhaler. After the mealtime insulin was titrated, there was a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels, which is the primary outcome parameter. The Company expects to release data from this study in the summer of 2013. The Full Research Report on MannKind Corporation - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/0b44_MNKD]
--
TESARO Inc. Research Report
On June 3, 2013, TESARO, Inc. (TESARO), Breast International Group (BIG), a non-profit organization for academic breast cancer research groups from around the world, and the European Organization for Research and Treatment of Cancer (EORTC), an international, independent, multidisciplinary non-profit research organization, announced a partnership for the Phase 3 clinical development of niraparib, an orally active, potent poly (ADP-ribose) polymerase (PARP) inhibitor. TESARO, BIG and EORTC will use BIG's and EORTC's scientific and clinical expertise and network of collaborative groups and their associated hospitals and oncology research centers to accelerate the completion of the Phase 3 clinical trial of niraparib in patients with breast cancer. The primary endpoint of this trial is progression free survival (PFS), with overall survival (OS) as a secondary endpoint. TESARO expects to open this study to patients during the second half of 2013. The Full Research Report on TESARO Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/4f59_TSRO]
--
Peregrine Pharmaceuticals Research Report
On June 3, 2013, Peregrine Pharmaceuticals, Inc. (Peregrine Pharmaceuticals) reported that data was presented at the 2013 ASCO (American Society of Clinical Oncology) Meeting from two clinical trials evaluating the Company's lead clinical candidate bavituximab, a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. Interim data from a Phase I trial, evaluating bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer (MBC), showed that 85% of patients were able to achieve objective tumor response, with 15% of patients achieving a complete response (CR) in accordance to Response Evaluation Criteria in Solid Tumors (RECIST). Further, the Company reported that in the second study, results from a randomized Phase II trial of bavituximab plus gemcitabine in patients with non-resectable Stage IV pancreatic cancer demonstrated more than a doubling of the overall response rate (ORR) and an improvement in overall survival (OS), including a delayed separation in the Kaplan-Maeier survival curve that is commonly seen in promising cancer immunotherapies. The Full Research Report on Peregrine Pharmaceuticals - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/df4a_PPHM]
--
Vanda Pharmaceuticals Inc. Research Report
On May 31, 2013, Vanda Pharmaceuticals Inc. (Vanda Pharmaceuticals) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tasimelteon, a circadian regulator in development for the treatment of non-24 hour disorder (Non-24) in the totally blind. Non-24 is a serious and rare, circadian rhythm disorder that affects the majority of totally blind individuals who lack light perception and, therefore, cannot synchronize their master body clock to the 24-hour day. There are currently no FDA approved products for the treatment of Non-24. The Full Research Report on Vanda Pharmaceuticals Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/b7a8_VNDA]
----
EDITOR NOTES:
This is not company news. We are an independent source and our views do not reflect the companies mentioned.
Information in this release is fact checked and produced on a best efforts basis and reviewed by a CFA. However, we are only human and are prone to make mistakes. If you notice any errors or omissions, please notify us below.
This information is submitted as a net-positive to companies mentioned, to increase awareness for mentioned companies to our subscriber base and the investing public.
If you wish to have your company covered in more detail by our team, or wish to learn more about our services, please contact us at pubco@EquityNewsNetwork.com.
For any urgent concerns or inquires, please contact us at compliance@EquityNewsNetwork.com.
Are you a public company? Would you like to see similar coverage on your company? Send us a full investors' package to research@EquityNewsNetwork.com for consideration.
COMPLIANCE PROCEDURE
Content is researched, written and reviewed on a best-effort basis. This document, article or report is prepared and authored by Equity News Network. An outsourced research services provider has, through Chartered Financial Analysts, only reviewed the information provided by Equity News Network in this article or report according to the Procedures outlined by Equity News Network. Equity News Network is not entitled to veto or interfere in the application of such procedures by the outsourced provider to the articles, documents or reports, as the case may be.
NOT FINANCIAL ADVICE
Equity News Network makes no warranty, expressed or implied, as to the accuracy or completeness or fitness for a purpose (investment or otherwise), of the information provided in this document. This information is not to be construed as personal financial advice. Readers are encouraged to consult their personal financial advisor before making any decisions to buy, sell or hold any securities mentioned herein.
NO WARRANTY OR LIABILITY ASSUMED
Equity News Network is not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted by Equity News Network whatsoever for any direct, indirect or consequential loss arising from the use of this document. Equity News Network expressly disclaims any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Equity News Network does not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.
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