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Portola's Betrixaban Gets Fast Track Designation in the U.S.

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Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Earlier this week, Portola Pharmaceuticals, Inc. PTLA announced that its anticoagulant candidate, betrixaban, was granted Fast Track designation by the FDA for extended-duration prevention of venous thromboembolism (VTE), or blood clots, in acute medically ill patients.

Betrixaban is currently in the phase III APEX study for the prevention of VTE in acute medically ill patients. Patient enrolment is expected to be completed by 2015-end. Top-line data is expected in the first quarter of 2016. The company plans to submit a New Drug Application later in 2016, assuming positive results from the ongoing phase III study.

Meanwhile, the company continues to progress on its pipeline. Currently, the company is evaluating cerdulatinib in a phase I/IIa proof-of-concept study for the treatment of patients with B cell leukemias or lymphomas with focus on genetically-defined subtypes, as well as in patients who have failed therapy due to relapse or acquired mutations.

Another candidate in the company's pipeline, andexanet alfa, is in a phase IV study for patients receiving a factor Xa inhibitor anticoagulant who suffer a major bleeding episode or who may require emergency surgery. The phase IV study is being conducted to support a Biologics License Application, which the company plans to submit by 2015-end.

Portola carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK , Endo International plc ENDP and Nexvet Biopharma Public Limited Company NVET , each sporting a Zacks Rank #1 (Strong Buy).

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ENDO INTL PLC (ENDP): Free Stock Analysis Report

PORTOLA PHARMA (PTLA): Free Stock Analysis Report

ANIKA THERAPEUT (ANIK): Free Stock Analysis Report

NEXVET BIOPHARM (NVET): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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