PTLA: FDA Approves Andexxa Gen 2 Manuf Process

PTLA: FDA Approves Andexxa Gen 2 Manuf Process Dec 31, 2018 20:48:32 GMT tomsylver likes this

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Post by icemandios on Dec 31, 2018 20:48:32 GMT

U.S. Food and Drug Administration Approves Portola Pharmaceuticals’ Prior Approval Supplement for Andexxa® Generation 2 Manufacturing Process

– Expands Patient Access to Andexxa, the First and Only Antidote for Reversal of

the Factor Xa Inhibitors Rivaroxaban or Apixaban

– Full Commercial Launch to Begin January 2019 –

SOUTH SAN FRANCISCO, Calif., Dec. 31, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Prior Approval Supplement (PAS) for its large-scale, second generation Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], allowing for broad commercial launch in the United States.

Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was initially 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.

“It is clear from the response to the Andexxa Early Supply Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban,” said Scott Garland, Portola’s president and chief executive officer. "We are pleased to now be able to stock hospitals nationwide and serve all patients in the U.S. who could benefit from the potential life-saving impact of Andexxa.”

The use of Factor Xa inhibitors is rapidly growing because of their efficacy and safety profile compared to enoxaparin and warfarin in preventing and treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism (VTE). This growth has come with a related increase in the incidence of hospital admissions and deaths related to bleeding, the major complication of anticoagulation. In the U.S. alone in 2017, there were approximately 140,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding.
The Company will provide additional details on the commercial launch plans for Andexxa during its annual corporate webcast scheduled for Tuesday, January 8, at 7:00 a.m. PT (10:00 a.m. ET). The live webcast will be available on the Company's website at www.portola.com.

PTLA: FDA Approves Andexxa Gen 2 Manuf Process Jan 9, 2019 15:26:12 GMT icemandios likes this

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Post by Deleted on Jan 9, 2019 15:26:12 GMT

There's hope for PTLA in 2019

Why Portola Pharmaceuticals Rose 8.09% on January 4## Stock performanceOn January 4, Portola Pharmaceuticals stock closed at $19.38, an 8.09% increase from its prior close of $17.93 on January 3. On December 31, 2018, Portola Pharmaceuticals stock price grew ~14.22% to reach $19.52 from its prior close of $17.09 on December 28.The stock price on January 4 was ~65% below its 52-week high of $55.48 on January 29, 2018. The company hit its 52-week low of $14.81 on December 24, 2018.## Recent developmentsOn December 2018, the US FDA (Food and Drug Administration) approved Portola Pharmaceuticals’ PAS (prior approval supplement) for large-scale, second-generation Andexxa. The approval enables a wide commercial launch of Andexxa in the US market.In May 2018, the FDA approved Andexxa under the accelerated approval pathway. The FDA also granted Andexxa an orphan drug designation and a breakthrough therapy designation. The approval is expected to boost the commercial launch of Andexxa in the US market, which in turn could significantly boost the revenue growth of Portola in 2019.## Financials in a nutshellIn the first nine months of 2018, Portola Pharmaceuticals’ net revenues grew ~95% YoY to reach $24.8 million from $12.7 million. Wall Street analysts estimate that Portola Pharmaceuticals will generate net revenues of $35.70 million, which represents ~58.35% YoY growth. The revenue growth of Portola Pharmaceuticals (PTLA) could boost the SPDR S&P Biotech ETF (XBI). The company makes up about ~1.31% of XBI’s total portfolio holdings.In the first nine months of 2018, Portola reported net income and EPS of -$261.7 million and -$3.97, respectively, compared to -$194.3 million and -$3.38 in the same period the prior year.Wall Street analysts estimate that Portola Pharmaceuticals will report net income and EPS of -$333.57 million and -$5.03, respectively, in fiscal 2018.## Analysts’ recommendationsOf the seven analysts tracking Portola Pharmaceuticals in January 2019, three of them recommended a “strong buy,” two analysts recommended a “buy” rating, and two analysts recommended a “hold” rating.On January 7, 2019, the company had a consensus 12-month target price of $35.83, which represents a ~84.88% return on investment over the next 12 months.

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Post by icemandios on Dec 31, 2018 20:48:32 GMT

Post by Deleted on Jan 9, 2019 15:26:12 GMT

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