Portola Announces FDA Drug Application Acceptance, Sets Up For A Pivotal Year Ahead

Portola Pharmaceuticals Inc PTLA announced the FDA acceptance of the new drug application and European Medicines Agency validation of the marketing authorization for betrixaban for use in acute medically ill patients. With this news, the application’s probability of success has increased,” Credit Suisse’s Vamil Divan said in a report.

Divan maintains a Neutral rating on the company, while raising the price target from $20 to $29.

Increase In POS

Betrixaban now has a "fast track" status. The FDA has assigned priority review for the application, with an action date set for June 24, 2017.

Divan increased the probability of success assumption for the product from 40 percent to 65 percent, saying, “The general understanding the FDA must already have of the APEX study results and the support the drug seems to have both with officials at the FDA and with thought leaders in the community.”

A Pivotal Year Ahead

The betrixaban Prescription Drug User Fee Act date of June 24, 2017, is the most important catalyst in the list of “several important catalysts” Portola Pharma has over the next 12 months, the analyst commented.

The FDA will hold an Advisory Committee meeting to discuss the betrixaban application in Q2. Although this is based on a single Phase 3 study that almost missed the primary endpoint, “the totality of the data remains encouraging,” Johnson noted. He expects the company to resubmit their application for andexanet alfa, a novel anticoagulant, in Q2, with a potential approval by yearend 2017.