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
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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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