Portola Pharmaceuticals to Present Full Results from the ANNEXA-4 Study of Andexxa During a Late-Breaking Oral Presentation a...
30 Janvier 2019 - 2:43PM
Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that
full results from the Company’s ANNEXA-4 study of Andexxa®
[coagulation factor Xa (recombinant), inactivated-zhzo] have been
accepted as a late-breaking oral presentation during the
International Stroke Conference (ISC) 2019. The data will be
presented on Thursday, February 7, 2019 at 11:36 a.m. Hawaii
Standard Time and has also been submitted for simultaneous
publication in a peer-reviewed medical journal.
Andexxa received both U.S. Orphan Drug and U.S.
Food and Drug Administration (FDA) Breakthrough Therapy
designations, and was approved on May 3, 2018 under the FDA's
Accelerated Approval pathway. It is the first and only antidote
indicated for patients treated with rivaroxaban or apixaban, when
reversal of anticoagulation is needed due to life-threatening or
uncontrolled bleeding.
Oral Presentation Title: Andexanet Alfa for
Treatment of Factor Xa Inhibitor-Related Acute Major Bleeding
- Session Title: Thursday Main Event
- Session Number: ME II
- Presenter: Truman J. Milling Jr., M.D., FACEP,
Seton Dell Medical School Stroke Institution
- Presentation Date and Time: Thursday, February
7, 2019 at 11:36 a.m. HST
- Location: Hawaii Convention Center, Hall
III
About Portola Pharmaceuticals,
Inc.Portola Pharmaceuticals is a commercial-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel therapeutics that could significantly
advance the fields of thrombosis and other hematologic diseases.
The Company’s two FDA-approved medicines are Andexxa® [coagulation
factor Xa (recombinant), inactivated-zhzo], the first and only
antidote for patients treated with rivaroxaban and apixaban when
reversal of anticoagulation is needed due to life-threatening or
uncontrolled bleeding, and Bevyxxa® (betrixaban), the first and
only oral, once-daily Factor Xa inhibitor for the prevention of VTE
in adult patients hospitalized for an acute medical illness. The
company also is advancing cerdulatinib, a Syk/JAK inhibitor for the
treatment of hematologic cancers.
Forward-Looking Statements
Statements contained in this press release regarding matters that
are not historical facts are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, Andexxa’s potential to
address life-threatening bleeding associated with the use of the
Factor Xa inhibitors apixaban or rivaroxaban. Risks that contribute
to the uncertain nature of the forward-looking statements include:
the risk that physicians, patients and payers may not see the
benefits of utilizing Andexxa or Bevyxxa for the indications which
they are approved; our ability to continue to manufacture our
products and to expand approved manufacturing facilities; the
possibility of unfavorable results from additional clinical trials
involving Andexxa; the risk that the EMA may not approve Andexxa in
the currently anticipated timelines or at all, and that any
marketing approvals or reimbursement limitations may have
significant limitations on its use; the risk that we may not obtain
additional regulatory approvals necessary to expand approved
indications for Andexxa; our expectation that we will incur losses
for the foreseeable future and will need additional funds to
finance our operations; the accuracy of our estimates regarding
expenses and capital requirements; our ability to successfully
build a hospital-based sales force and commercial infrastructure;
our ability to obtain and maintain intellectual property protection
for our product candidates; and our ability to retain key
scientific or management personnel. These and other risks and
uncertainties are described more fully in our most recent filings
with the Securities and Exchange Commission, including our most
recent quarterly report on Form 10-Q. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. We undertake no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
Investor Contact: |
Media Contact: |
Cara Miller |
Julie Normart |
Portola Pharmaceuticals |
Pure Communications |
IR@portola.com |
jnormart@purecommunications.com |
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