Health and Healthcare

Is Galena Dead in the Water After This Failed Trial?

Chris Lange

Published: June 29, 2016 1:21 pm

Last Updated: January 13, 2020 6:13 am

Galena Biopharma, Inc. (NASDAQ: GALE) is absolutely crashing on Wednesday after the company released further information regarding its Breast Cancer clinical trial. The company announced the recommendation from the Independent Data Monitoring Committee (IDMC) on the interim analysis for Galena’s NeuVax (nelipepimut-S) Phase 3 PRESENT clinical trial.

On June 27, the IDMC recommended that the PRESENT trial be stopped due to futility. This planned safety and futility interim analysis was triggered after 70 qualifying disease-free survival (DFS) events were reached, and a total of 71 events were reviewed by the IDMC.

A total of 758 patients were enrolled, and the primary endpoint for the trial was disease free survival (DFS) upon reaching 141 events with 3 years minimum follow-up.

Mark W. Schwartz, Ph.D., President and CEO of Galena, commented:

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.  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.

So far in 2016, Galena actually outperformed the market with the stock up 38% at Tuesday’s close. However, after the announcement shares came crashing down.

Shares of Galena were last trading down about 85% at $0.31, with a consensus analyst price target of $3.90 and a 52-week trading range of $0.28 to $2.49.