FDA Approvals, Financial Highlights, Restated Treatment Indications, and Updates on Product Pipelines - Analyst Notes on Bristol-Myers Squibb, Galena, Teleflex, GW Pharmaceuticals, and CytRx
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NEW YORK, March 21, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Bristol-Myers Squibb Company (NYSE: BMY), Galena Biopharma, Inc. (NASDAQ: GALE), Teleflex Incorporated (NYSE: TFX), GW Pharmaceuticals plc (NASDAQ: GWPH), and CytRx Corporation (NASDAQ: CYTR). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.AnalystsReview.com/register
Bristol-Myers Squibb Company Analyst Notes
On March 14, 2014, Bristol-Myers Squibb Company (Bristol-Myers Squibb) announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) in patients who have undergone hip or knee replacement surgery. This sNDA approval for Eliquis for the prophylaxis of deep vein thrombosis (DVT) is supported by three clinical trials. "Today's FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation," said Brian Daniels, M.D., Senior Vice President of Global Development and Medical Affairs at Bristol-Myers Squibb. The full analyst notes on Bristol-Myers Squibb Company are available to download free of charge at:
http://www.AnalystsReview.com/03212014/BMY/report.pdf
Galena Biopharma, Inc. Analyst Notes
On March 17, 2014, Galena Biopharma, Inc. (Galena) reported its Q4 2013 and full-year 2013 financial results. For Q4 2013, the Company reported net revenue of $1.3 million, whereas no revenues were recognized in the comparable previous year period. Net loss for the quarter was $48.5 million, or $0.46 per diluted share, compared to a net loss of $3.2 million, or $0.05 per diluted share, in Q4 2012. For full-year 2013, net revenue was $2.5 million, whereas no revenues were recognized for the comparable previous year period. Full-year net loss was $76.7 million or $0.85 per diluted share, compared to a net loss of $35.0 million or $0.56 per diluted share in 2012. Ryan Dunlap, Vice President and CFO of Galena said, "We are pleased to report $2.5 million net revenue for Abstral consistent with our guidance of $1.5 to $3 million for 2013. We expect net revenue to increase throughout 2014 based on anticipated increases in the number of Abstral prescriptions fulfilled, combined with the execution of programs which are projected to significantly reduce our gross-to-net revenue adjustments." The full analyst notes on Galena Biopharma, Inc. are available to download free of charge at:
http://www.AnalystsReview.com/03212014/GALE/report.pdf
Teleflex Incorporated Analyst Notes
On March 17, 2014, Teleflex Incorporated (Teleflex) announced FDA 510(k) clearance for restated Indications for Use of the EZ-IO® Vascular Access System. The EZ-IO® 25 mm Needle Set is now indicated for patients 3 kg or over. "As part of our fight for zero complications in vascular access, we are committed to continuously improving our technologies, enhancing our training and educational initiatives, and partnering with healthcare professionals to provide innovative solutions for treating difficult vascular access patients with the EZ-IO® Vascular Access System," said Jay White, President and General Manager of Vascular Access Division at Teleflex. The full analyst notes on Teleflex Incorporated are available to download free of charge at:
http://www.AnalystsReview.com/03212014/TFX/report.pdf
GW Pharmaceuticals plc Analyst Notes
On March 17, 2014, GW Pharmaceuticals plc (GW Pharmaceuticals) announced updates on the Company's cannabinoid pipeline. The Company has completed a Phase 1 clinical trial of GWP42006 to treat epilepsy. GWP42006 is a product which features the non-psychoactive cannabinoid cannabidivarin (CBDV) extracted from the cannabis plant. CBDV has shown the ability to treat seizures in pre-clinical models of epilepsy with significantly fewer side effects than currently approved anti-epileptic drugs. The Company also commenced a 12-week randomized, double blind, placebo controlled Phase 2b study of GWP42004 to treat Type 2 diabetes. GW believes that GWP42004 would have the potential to offer a novel orally-administered treatment option within one of the largest therapeutic areas where a serious unmet medical need still exists. GW has also commenced a Phase 2a trial using GWP42003 to treat Schizophrenia. GWP42003 has shown notable anti-psychotic effects in accepted pre-clinical models of schizophrenia and has also demonstrated the ability to reduce the characteristic movement disorders induced by currently available anti-psychotic agents. The full analyst notes on GW Pharmaceuticals plc are available to download free of charge at:
http://www.AnalystsReview.com/03212014/GWPH/report.pdf
CytRx Corporation Analyst Notes
On March 5, 2014, CytRx Corp. (CytRx) reported its full-year 2013 financial results. The Company reported net loss of $47.5 million, or $1.44 per diluted share, compared with a net loss of $18.0 million, or $0.78 per diluted share in full year 2012. Steven A. Kriegsman, CytRx President and CEO, said, "We are entering 2014 on firm financial ground, having recently raised approximately $86 million, before deducting expenses, along with a cash balance of $38.5 million at year end 2013. With this strong balance sheet, we are well funded to execute on our corporate objectives for the foreseeable future." In October 2013 and February 2014, CytRx successfully completed two public offerings of common stock securing gross proceeds of approximately $26 million and $86 million, respectively. The full analyst notes on CytRx Corporation are available to download free of charge at:
http://www.AnalystsReview.com/03212014/CYTR/report.pdf
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