Wired News – Portola Pharmaceuticals Provides Update On Commercial Launch of Bevyxxa(R)
Stock Monitor: Urogen Pharma Post Earnings
Reporting
LONDON, UK / ACCESSWIRE / November 27, 2017 / Active-Investors issued a free report on Portola
Pharmaceuticals, Inc. (NASDAQ: PTLA) (“Portola”), which is readily accessible upon registration
at www.active-investors.com/registration-sg/?symbol=PTLA as the Company’s latest news hit the wire. On November
21, 2017, the biopharmaceutical Company, which develops product candidates in
the fields of thrombosis and other hematologic diseases, announced that the US
Food and Drug Administration (“FDA”, or ‘the agency’) has extended the review
period for its Prior Approval Supplement (PAS) for Bevyxxa® (betrixaban). This
would give sufficient time to the agency to thoroughly review Portola’s
submission. Sign up now for our free
research reports at: www.active-investors.com/registration-sg.
Active-Investors.com is currently working on the research
report for Urogen Pharma Ltd (NASDAQ: URGN), which also belongs to the Healthcare
sector as the Company Portola Pharma. Do not miss out and become a member today
for free to access this upcoming report at: www.active-investors.com/registration-sg/?symbol=URGN.
Active-Investors.com is focused on
giving you timely information and the inside line on companies that matter to
you. This morning, Portola Pharma most recent news
is on our radar and we have decided to include it on our blog post. Today’s
free coverage is available at: www.active-investors.com/registration-sg/?symbol=PTLA.
About Bevyxxa®
Bevyxxa® is Portola’s first medicine. It
is an oral, once-daily Factor Xa inhibitor, which was approved by the FDA on
June 23, 2017.
Currently, Bevyxxa® is the first and only
anticoagulant for hospital and extended duration prophylaxis (i.e. around 35 to
42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an
acute medical illness, and who are at risk for thromboembolic complications due
to moderate or severe restricted mobility and other risk factors for VTE.
Notification from the FDA
The FDA communicated to Portola that it
would revert on its PAS request to change the existing manufacturing release
specification within the standard extension period of 60 days.
The agency specified a new action date of
January 30, 2018.
However, the FDA did not ask for any
additional information from Portola at this point.
Bevyxxa® Commercial Launch Expected
in February 2018
Bill
Lis, Chief Executive Officer (CEO) at Portola, shared that the Company has made
good progress with the FDA for the product release so far. Portola has already
entered into an agreement in principle for the change of its product release
specification, which would help in the release and distribution of the existing
product inventory.
The
FDA might need more time to review the PAS application. And while the agency
completes its review, the momentum for Bevyxxa® within the medical community is
building. Portola expects to commercially launch Bevyxxa® by February 2018.
Till then, it intends to continue with its commercial and medical education
activities, in preparation for the launch.
Once
Bevyxxa® launches, it would prove to be a potentially life-saving new therapy
for VTE in hospitalized adult patients who at risk of developing VTE.
Portola Shared Third Quarter 2017
Results
Portola
reported its financial results on November 06, 2017, for the third quarter
ending September 30, 2017.
The total collaboration and license
revenue earned by the Company was $3.8 million, down from $9.3 million for the
third quarter of 2016.
Portola reported a net loss of $82.9
million, or $1.41 net loss per share, compared to a net loss of $92.9 million,
or $1.64 net loss per share, for the same period in 2016.
The net cash, cash equivalents, and
investments totaled $597.8 million.
Stock Performance Snapshot
November
24, 2017 – At Friday’s closing bell, Portola Pharma’s stock
fell 1.40%, ending the trading session at $50.55.
Volume traded for the
day: 330.61 thousand shares.
Stock performance in the
last month – up 3.50%; previous six-month period – up 37.66%; past twelve-month
period – up 167.04%; and year-to-date – up 125.27%
After last Friday’s
close, Portola Pharma’s market cap was at $3.35 billion.
The stock is part of the Healthcare
sector, categorized under the Biotechnology industry. This sector was up 0.3%
at the end of the session.
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