Portola Pharma Shares Under Pressure After FDA Extension

Portola Pharmaceuticals Inc PTLA shares are down Tuesday after the company's Friday announcement that the FDA has extended its review period for the biologics license application for AndexXa, an anticoagulant antidote product candidate, by 90 days.

In August 2016, the company received complete response letter delaying the therapy's approval. The drug watchdog had sought additional data to support the inclusion of edoxaban and enoxaparin in the label, while it also needed to finalize its review of the clinical amendments to the company's post-market commitments.

The Analyst

William Blair analyst Matt Phipps has an Outperform rating on Portola Pharma.

The Thesis

The recent extension of the review period is to allow the FDA time to review additional information recently submitted by the company, and further discuss labeling and post-marketing commitments, Phipps said in a Tuesday morning note.

The submission in question included additional data requested by the FDA from the ANNEXA-4 study, which evaluated AndexXa in patients on a Factor Xa inhibitor with an acute major bleeding episode, the analyst said.

Notwithstanding the setback, which has led to disappointment among investors, Phipps said he continues to believe AndexXa will receive FDA approval, with a decision date of May 4.

William Blair revised its commercial estimates for AndexXa based on updated timelines in 2018, with the U.S. launch now likely toward the end of the second quarter and the European launch expected in the near term. 

This expectation, combined with the commercial launch of Bevyxxa, meant for the prophylaxis of venous thromboembolism, provides significant upside potential to the current share price of Portola Pharma, Phipps said. 

Bevyxxa was approved by the FDA on June 23, 2017.

The Price Action

Shares of Portola Pharma are up about 145 percent year-to-date until Dec. 22.

The shares were shedding 8.28 percent to $50.32 at last check in reaction to the FDA extension. 

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