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PTLA

Portola Pharmaceuticals

$38.25

-1.24 (-3.14%)

13:06
06/23/17
06/23
13:06
06/23/17
13:06

Portola Pharmaceuticals announces FDA approval of Bevyxxa

Portola Pharmaceuticals announced the U.S. Food and Drug Administration has approved Bevyxxa, which it said is "the first and only" anticoagulant for hospital and extended duration prophylaxis of venous thromboembolism, or VTE, in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. The timeline on which Portola expects to launch Bevyxxa is between August and November 2017. During this period, Portola will complete salesforce hiring and training, drug manufacturing validation and inventory buildup, the company said.

  • 23

    Jun

  • 24

    Jun

PTLA Portola Pharmaceuticals
$38.25

-1.24 (-3.14%)

04/12/17
SBSH
04/12/17
NO CHANGE
Target $51
SBSH
Buy
Neurocrine approval reads positive for Portola, says Citi
Citi analyst Yigal Nochomovitz believes the approval of Neurocrine Biosciences' (NBIX) Ingrezza following a canceled advisory panel has a positive read-across to the ongoing FDA review for Portola Pharmaceuticals' (PTLA) betrixaban. The FDA had originally informed Portola to anticipate an advisory panel back in late December 2016, but in early February 2017 we learned the FDA was no longer requesting a panel, Nochomovitz tells investors in a research note. Ingrezza makes it four drugs out of four that got approved when a panel was canceled and there were no significant review issues identified by the FDA, the analyst adds, citing his analysis. The analyst notes he confirmed with Portola that no material issues were raised at the mid-cycle communication with the FDA on betrixaban. He keeps a Buy rating on Portola with a $51 price target.
04/19/17
SBSH
04/19/17
NO CHANGE
Target $51
SBSH
Buy
Citi says FDA analysis further supports Portola approval
Citi analyst Yigal Nochomovitz says his analysis of FDA precedence further supports approval of Portola Pharmaceuticals' novel blood thinner betrixaban. The FDA decision date is June 24. Two of the 29 drugs that were approved under Priority Review and no panel also missed their primary endpoints, Nochomovitz tells investors in a research note. He keeps a Buy rating on Portola with a $51 price target.
06/16/17
SBSH
06/16/17
NO CHANGE
Target $51
SBSH
Buy
Portola's interim cerdulatinib data 'look good,' says Citi
Citi analyst Yigal Nochomovitz says Portola Pharmaceuticals' interim cerdulatinib data in relapsed/refractory B-cell malignancies "look good" and provide upside not in his model. Success in developing cerdulatinib for this indication could provide additional upside for the shares, Nochomovitz tells investors in a research note. He keeps a Buy rating on Portola with a $51 price target.
06/23/17
SBSH
06/23/17
NO CHANGE
SBSH
Buy
FDA precedent points to decision on Portola's betrixaban coming today, says Citi
After examining 22 cases over the last three years where a PDUFA date for a drug's approval fell on a weekend or holiday, Citi analyst Yigal Nochomovitz found a "strong bias" for the FDA to issue its decision prior to, rather than on or after, the deadline date. Given that the PDUFA date for Portola's betrixaban falls on Saturday, June 24, Nochomovitz said he expects the FDA to issue its decision on betrixaban today, June 23. The analyst, who sees a high probability of approval, keeps a Buy rating on Portola shares.

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