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PTLA

Portola Pharmaceuticals

$50.80

1.29 (2.61%)

18:23
11/21/17
11/21
18:23
11/21/17
18:23

Portola: FDA extends review period for PAS for Bevyxxa

Portola Pharmaceuticals announced that the U.S. Food and Drug Administration has extended the review period for the company's Prior Approval Supplement for Bevyxxa to allow the agency time to review the entire submission. The FDA informed the company today that it will respond to the PAS request to change the current manufacturing release specification within the standard 60-day extension period. No additional information was requested at this time. The new action date is January 30, 2018. "As we communicated earlier this month, we've made good progress with the FDA and have established an agreement in principle on the change to our product release specification that would allow for the release and distribution of current product inventory. We also noted that the agency might need additional time to review our submission," said Bill Lis, chief executive officer of Portola. "While the FDA completes its review, the momentum within the medical community is building. We continue our commercial and medical education activities in anticipation of a potential launch by February 2018, and remain committed to getting Bevyxxa to patients who may benefit from this important and potentially life-saving new therapy."

  • 02

    Feb

PTLA Portola Pharmaceuticals
$50.80

1.29 (2.61%)

09/19/17
OPCO
09/19/17
NO CHANGE
OPCO
Outperform
Portola Pharmaceuticals mentioned positively at Oppenheimer
09/19/17
OPCO
09/19/17
NO CHANGE
OPCO
Outperform
Portola selloff today based on 'stale' guidelines draft, says Oppenheimer
Oppenheimer analyst Jay Olson views the selloff today in shares of Portola Pharmaceuticals as "off-target." The decline is based on the rehashing of draft guidelines that were available for public comment from July 24 to August 25, Olson tells investors in an afternoon research note titled "Stale Draft Recommendations for VTE Mysteriously Resurface." The draft references the August 2016 New England Journal of Medicine article for Portola's Bevyxxa versus Lovenox in cohort one on the primary efficacy outcome, the analyst notes. He expects revised final guidelines to be published by year-end and keeps an Outperform rating on Portola. The stock in afternoon trading is down 7% to $52.52 after STAT News said the company's blood thinner launch could be complicated by the guidelines.
09/19/17
SBSH
09/19/17
NO CHANGE
SBSH
Buy
Portola selloff on draft guidance 'red herring' a buying opportunity, says Citi
Citi analyst Yigal Nochomovitz attributes today's selloff in Portola Pharmaceuticals shares to controversy over the fact that the American Society of Hematology's draft recommendations argue against extended prophylaxis for VTE in acute medically ill patients. However, he points out that the document lacks any mention of Bevyxxa's status as FDA approved, which suggests the draft "needs to be revisited and/or is stale." The analyst concludes the draft was made prior to Bevyxxa approval and before the "many, many downstream publications" Portola has generated since then. Nochomovitz, who recommends investors buy the dip, keeps a Buy rating on Portola, which is down 7% in afternoon trading.
09/20/17
FBCO
09/20/17
NO CHANGE
Target $70
FBCO
Outperform
Portola Pharmaceuticals selloff surprising, says Credit Suisse
Credit Suisse analyst Vamil Divan says he is surprised that Portola shares sold off about 8% on concerns that extended duration VTE prophylaxis for acute medically ill patients is not recommended in draft guidelines from the American Society of Hematology. The analyst believes the negative reaction is unwarranted, and reiterates an Outperform rating and $70 price target on the shares.

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