Portola Pharma Rips 20% Higher After FDA Approves Andexxa Antidote

Portola Pharmaceuticals Inc PTLA shares reclaimed the $40 level for the first time since February after a positive FDA decision on a drug meant to reverse anticoagulation brought about by drugs such as Bayer AG (ADR) BAYRY's rivaroxaban, and apixaban jointly developed by Pfizer Inc. PFE and Bristol-Myers Squibb Co BMY.

What Happened

Portola said the FDA approved its andexanet alfa, a factor Xa inhibitor reversal agent. The stock was up more than 23 percent at the time of publication Friday afternoon. 

Why It's Important

The FDA had issued a complete response letter for the drug's biologics license application in August 2016. The agency accepted a resubmission in August 2017 and set a revised date of Feb. 2, 2018. 

This was extended by three months to May 4 to give enough time to parse additional data from the ongoing ANNEXA-4 study. The delay sent shares down by 10 percent when it was announced Dec. 22.

Portola shares came under selling pressure yet again March 1, when the company indicated on its fourth quarter earnings call that the FDA sought additional data that could necessitate an additional trial.

The FDA approval was worth the wait, Credit Suisse analyst Vamil Divan said in a Thursday note. The analyst forecast $10-plus in upside to Portola shares  — despite post-approval stipulations for a study of improvement in patients' homeostasis and a black box warning on thrombosis risks. 

Credit Suisse has an Outperform rating and $49 price target on Portola shares.

What's Next

The homeostasis trial is scheduled to begin in 2019, with results due in 2023. The study is to demonstrate an improvement in hemostasis in patients treated with AndexXa relative to those treated with the usual care.

"The post-approval commitment and a black box warning discussing the risk of thrombosis with AndexXa are not unexpected," Divan said in a note.

The pharma company expects to launch the product under an Early Supply Program with a Generation 1 product in June, while a commercial launch is planned in early 2019 contingent on the FDA's vetting of the Generation 2 manufacturing process.

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