Galena Biopharma Plunges 80% Amid Discontinued NeuVax Phase 3, PRESENT Interim Analysis

Galena Biopharma, Inc. GALE revealed it discontinued NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical study.

In the pre-market, the stock traded down more than 80 percent to $0.39.

According to Galena, the decision was taken based on the recommendation of the Independent Data Monitoring Committee (IDMC) on the interim analysis of its NeuVax. The company added that on June 27, the IDMC recommended that the PRESENT trial be stopped due to futility.

The company indicated it was attaching the letter along with the Form 8-K that was filed on Wednesday. The pharma firm said that the planned safety and futility interim analysis was due to 70 qualifying disease free survival (DFS) events as the IDMC reviewed a total of 71 events.

Galena's President and CEO, Mark Schwartz, said, "We are extremely disappointed with the outcome of the PRESENT futility analysis. On behalf of our entire company, I would like to thank all of the courageous patients and their families, investigators, study staff and independent committees who participated in the PRESENT study."

He added, "To date, the trial has not been un-blinded other than by the IDMC, and we need to evaluate the data. We expect to host a conference call next week to provide a preliminary review of the PRESENT trial and an update on all of our immunotherapy and hematology clinical development programs."

Posted In: BiotechNewsFDAGeneral
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