A Surprisingly Clean, Straightforward Approval Gives Portola Pharma Shares A Shot Of Upside

Portola Pharmaceuticals Inc PTLA announced last Friday the FDA has approved Brvyxxa, its anti-coagulant candidate. Bevyxxa is an oral, once-daily Factor Xa inhibitor, was granted a Fast Track designation and approved under Priority review, which reduces the timeframe for review to six months, as opposed to the ten months for a Standard review.

The company said it expects to launch Bevyxxa between August and November 2017.

Reaching The Apex

Commenting on the approval, Credit Suisse said Portola had reached its apex with Bevyxxa's surprisingly clean and straightforward approval, as opposed to its expectations that the mixed data from APEX study and an unfavorable risk/reward reduced the probability of approval to 70 percent.

Analysts Vamil Divan, Barbara Kotei and Duaa Mohamed noted that the FDA was fairly comfortable with the full dataset and provided a relatively clean and broad label. The analysts also said the Black Box Warning was expected, as with the other anti-thrombotics.

Not Bothered By AndexXa Delay

Credit Suisse said it isn't overly concerned by the minor delay announced by the company in its resubmission timeline for the AndexXa BLA from the second quarter of 2017 to July 2017. The firm believes even with the delay, the company has two potentially wholly-owned assets on the U.S. market by early next year.

As such, Credit Suisse maintains its Neutral rating on the shares of Portola, but raised its price target from $39 to $58.

Scenarios Supporting Upside

The firm said it sees potential further upside if the company:

• Successfully launches Bevyxxa.
• Obtains approval for AndexXa by January 2018.
• And/or is acquired by one of the several biotechnology companies that could be interested in its assets.

Potential Suitors

Among its coverage universe, Credit Suisse sees Portola being chased by Pfizer Inc. PFE, Bristol-Myers Squibb Co BMY and Merck & Co., Inc. MRK.

At the time of writing, shares of Portola were 6.42 percent higher at $59.66, tacking onto the 47 percent surge last Friday in the wake of the FDA news.

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