Portola's Shares Plunge on Blood Clot Trial

Portola Pharmaceuticals Inc. said its blood-clot treatment, an oral drug, showed no statistical difference in treating the condition than the current standard of care, an injectable blood thinner, according to the results of a phase 3 trial.

The company's stock plunged 29% to $20.40 in premarket trading. Shares have been battered recently, falling 44% in the past three months through Wednesday's close.

The trial evaluated whether extended-duration anticoagulation with oral betrixaban, the Portola drug, was superior in preventing blood clots compared with the standard of care, anticoagulation with injectable enoxaparin, a widely-used blood thinner.

The trial focused specifically on acute medically ill patients, defined as those hospitalized for serious common medical conditions, such as heart failure, stroke, infection and pulmonary disease.

Results showed there was no statistical difference in major bleeding between patients who received betrixaban and those who received enoxaparin in any of the trial's three patient groups.

However, the company said it did observe positive net clinical benefit with betrixaban. The number of intracranial hemorrhages—bleeding inside the skull—was lower in the betrixaban arm of the trial.

Bill Lis, chief executive of Portola, suggested that the company would still seek regulatory approval of the drug.

"We believe the overall robustness of the efficacy and safety results in this high-risk patient population, including the positive net clinical benefit observed, provide ample evidence to support the submission of an NDA later this year," Mr. Lis said, referencing a new drug application with the Food and Drug Administration.

The company was slated to host a conference call to discuss the company's outlook at 8:30 a.m. ET.

Write to Joshua Jamerson at joshua.jamerson@wsj.com

(END) Dow Jones Newswires

March 24, 2016 09:25 ET (13:25 GMT)

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