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Clinical Study Results, Pending Applications, Trial Updates, and Discontinued Trials - Research Report on ICU Medical, Exelixis, Cempra, Exact Sciences, and Onconova

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NEW YORK, December 25, 2013 /PRNewswire/ --

Today, Analysts' Corner announced new research reports highlighting ICU Medical, Inc. (NASDAQ: ICUI), Exelixis, Inc. (NASDAQ: EXEL), Cempra, Inc. (NASDAQ: CEMP), Exact Sciences Corporation (NASDAQ: EXAS), and Onconova Therapeutics, Inc. (NASDAQ: ONTX). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.

ICU Medical, Inc. Research Report

On December 12, 2013, ICU Medical, Inc. (ICU Medical) announced that two new studies presented at the American Society of Health-System Pharmacists (ASHP) Midyear Meeting and Exhibition in Orlando demonstrated that its newly launched ChemoLock closed system transfer device (CSTD) prevents hazardous drug surface contamination while eliminating leakage and providing a completely dry disconnect. The Company informed that ChemoLock is the first and only needlefree CSTD to receive the US Food and Drug Administration (FDA) 510(k) clearance for pharmacy applications, as well as patient administration applications. Further, ICU Medical notified that the two studies are the first independent studies to verify the efficacy of the ChemoLock system. The Full Research Report on ICU Medical, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:



Exelixis, Inc. Research Report

On December 19, 2013, Exelixis, Inc. (Exelixis) announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion of the Marketing Authorization Application (MAA) for COMETRIQ (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). According to the Company, MAA upon which the CHMP issued its opinion contains data from EXAM, the international, multi-center, randomized double-blinded controlled phase 3 clinical trial conducted in 330 patients with progressive, unresectable locally advanced or metastatic MTC, in which cabozantinib met its primary efficacy endpoint of improving progression-free survival (PFS) as compared to placebo. The Company notified that the CHMP's positive opinion will be reviewed by the European Commission, and upon European Commission's approval, Swedish Orphan Biovitrum (Sobi) would support COMETRIQ's commercialization in the European Union for the approved indication through the end of 2015, pursuant to the terms of a commercialization and distribution agreement between Exelixis and Sobi signed in January 2013. The Full Research Report on Exelixis, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:



Cempra, Inc. Research Report

On December 16, 2013, Cempra, Inc. (Cempra) provided an update on the clinical development of solithromycin and Taksta. The Company informed that it has recently initiated Solitaire-IV, a global solithromycin IV-to-oral Phase 3 clinical trial, in patients with community-acquired bacterial pneumonia (CABP). "Cempra is focused on developing truly differentiated antibiotics for the acute care and community settings that we believe will offer significant benefit to patients, payors and providers. The goal of Solitaire-IV is to provide evidence of safety and efficacy of an IV-to-oral step down regimen that we believe will provide clinicians and their patients a better therapeutic option to treat CABP," said Prabhavathi Fernandes, Ph.D., President and CEO of Cempra. In addition, the Company informed that in the Phase 2 study of Taksta, under which 50 patients with prosthetic joint infection (PJI) will be randomized to receive either oral Taksta plus rifampin or current standard of care, 31 subjects with PJI have been screened, at 14 sites, of which 21 subjects were enrolled on Taksta plus rifampin. "Despite the small number of patients that completed the trial so far due to the original exclusive entry criteria, the results to date are consistent with a positive effect of Taksta in this indication. Along with the very strong results from studies world wide of fusidic acid in PJI, the active antibiotic of Taksta, we are optimistic that this study will lay the groundwork for a defined Phase 3 study," said Dr. Fernandes. The Full Research Report on Cempra, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:



Exact Sciences Corporation Research Report

On December 3, 2013, Exact Sciences Corporation (Exact Sciences) announced that the US Food and Drug Administration's (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for the Company's Cologuard stool-DNA-based, non-invasive colorectal cancer screening test on March 26, 2014. "We look forward to discussing with the panel members the DeeP-C clinical trial results and the value of colorectal cancer screening with Cologuard," said Kevin T. Conroy, Exact Sciences' President and CEO. The Full Research Report on Exact Sciences Corporation - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:



Onconova Therapeutics, Inc. Research Report

On December 17, 2013, Onconova Therapeutics, Inc. (Onconova) announced the discontinuation of the Phase 3 ONTRAC study of intravenous (IV) rigosertib plus gemcitabine in front-line metastatic pancreatic cancer. The Company informed that after completion of a planned interim analysis, the Data Safety Monitoring Board (DSMB) has determined that the combination of rigosertib and gemcitabine is unlikely to demonstrate a statistically significant improvement in overall survival compared to gemcitabine alone. "We are very disappointed by these results, especially for patients with metastatic pancreatic cancer, given the lack of meaningful treatment options," said Ramesh Kumar, Ph.D., President and CEO of Onconova. "We would like to thank the patients and investigators for their participation in this trial." The Full Research Report on Onconova Therapeutics, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at:




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