Agreements, Financial Results, Clinical Study Results, Debt Financing, and Drug Application Updates - Analyst Notes on Tesaro, Chelsea Therapeutics, Venaxis, Geron, and Unilife
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NEW YORK, March 19, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Tesaro, Inc. (NASDAQ: TSRO), Chelsea Therapeutics International Ltd. (NASDAQ: CHTP), Venaxis, Inc. (NASDAQ: APPY), Geron Corporation (NASDAQ: GERN), and Unilife Corporation (NASDAQ: UNIS). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.AnalystsReview.com/register
Tesaro, Inc. Analyst Notes
On March 13, 2014, Tesaro, Inc. (Tesaro), along with AnaptysBio, Inc., announced an exclusive, worldwide license agreement and immuno-oncology antibody collaboration. According to the Company, under the terms of agreement, Tesaro receives rights to monospecific antibody drug candidates targeting TIM-3, LAG-3 and PD-1 and dual reactive antibody drug candidates targeting PD-1/TIM-3 and PD-1/LAG-3. Commenting on the collaboration, Mary Lynne Hedley, Ph.D., President of Tesaro, stated, "This agreement provides TESARO with a basis from which to develop novel therapeutics, including combination-based approaches, against a variety of tumor targets and may uniquely position TESARO for collaborations with new partners. The first clinical trial from this collaboration is projected to begin in mid-2015, and we expect to advance an additional candidate into clinical trials every one to two quarters thereafter." The full analyst notes on Tesaro, Inc. are available to download free of charge at:
http://www.AnalystsReview.com/03192014/TSRO/report.pdf
Chelsea Therapeutics International Ltd. Analyst Notes
On March 11, 2014, Chelsea Therapeutics International Ltd. (Chelsea Therapeutics) reported its Q4 2013 and full-year 2013 financial results. Q4 2013 net loss was $5.3 million or $0.07 per diluted share, compared to Q4 2012 net loss of $2.2 million or $0.03 per diluted share. Net loss for full year 2013 was $16.4 million or $0.24 per diluted share, compared to net loss for full year 2012 of $31.7 million or $0.47 per diluted share. Joseph G. Oliveto, President and CEO of the Company, stated, "DA approval of NORTHERA™ (droxidopa) this February for symptomatic neurogenic orthostatic hypotension is Chelsea Therapeutics' most important milestone to date. NORTHERA is the first new treatment option approved for this indication in nearly two decades, representing a significant market opportunity. We continue to pursue a dual path of actively assessing the Company's strategic alternatives and preparing for the commercial launch of NORTHERA." The full analyst notes on Chelsea Therapeutics International Ltd. are available to download free of charge at:
http://www.AnalystsReview.com/03192014/CHTP/report.pdf
Venaxis, Inc. Analyst Notes
On March 13, 2014, Venaxis, Inc. (Venaxis) announced positive top-line results from its pivotal U.S. study. According to Venaxis, the APPY1 Test performed well, with sensitivity and negative predictive value results that exceeded those from the previous pilot study. Additionally, the Company stated that it believes the pivotal results are sufficient for potential FDA clearance and expects to finalize its 510(k) submission and file with the FDA. Steve Lundy, President and CEO of the Company stated, "The positive outcome from this study is a significant achievement for Venaxis, and I want to commend our team and our clinical partners on a very well-run study. Our goal is to be well positioned for successful product launch upon potential FDA clearance of the APPY1 Test." The full analyst notes on Venaxis, Inc. are available to download free of charge at:
http://www.AnalystsReview.com/03192014/APPY/report.pdf
Geron Corporation Analyst Notes
On March 12, 2014, Geron Corporation (Geron) announced that the Company has received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for imetelstat has been placed on full clinical hold. According to Geron, the clinical hold affects all ongoing Company-sponsored clinical trials. Additionally, the Company stated that it has not yet received written notice of its clinical hold from the FDA but based on the verbal communication, the FDA indicated that the clinical hold is due to the occurrence of persistent low-grade liver function test abnormalities observed in the Phase 2 study of imetelstat in ET/PV patients and the potential risk of chronic liver injury following long-term exposure to imetelstat. Geron added that it plans to work diligently with the FDA to seek the release of the clinical hold. The full analyst notes on Geron Corporation are available to download free of charge at:
http://www.AnalystsReview.com/03192014/GERN/report.pdf
Unilife Corporation Analyst Notes
On March 13, 2014, Unilife Corporation (Unilife) announced that it has entered into a $60 million debt financing agreement with an affiliate of OrbiMed. According to the Company, $40 million was funded to Unilife at the closing of the deal, and two additional tranches of $10 million each will be provided to the Company in December 2014 and June 2015, provided the Company is in compliance with the terms of the agreement. Additionally, Unilife stated that it will make interest-only payments to OrbiMed currently calculated at a rate of 10.25% per annum, with the principal to be repaid by March 12, 2020, within the six-year term of the agreement. Unilife Chairman and CEO Mr. Alan Shortall, stated, "This $60 million commitment provides us with the necessary capital to drive business growth as we bring several large contracts with existing customers through to commercial rollout." The full analyst notes on Unilife Corporation are available to download free of charge at:
http://www.AnalystsReview.com/03192014/UNIS/report.pdf
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