Stock Update (NASDAQ:GALE): Galena Biopharma Inc Discontinues NeuVax™ Phase 3, PRESENT Interim Analysis


Galena Biopharma Inc (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, announced the recommendation from the Independent Data Monitoring Committee (IDMC) on the interim analysis for Galena’s 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 trial. On June 27, 2016, the IDMC recommended that the PRESENT trial be stopped due to futility. The letter is attached to the Form 8-K filed today and available on the Company’s website.  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.

“We are extremely disappointed with the outcome of the PRESENT futility analysis,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer.  “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.” (Original Source)

Shares of Galena Biopharma are falling nearly 80% in pre-market trading. GALE has a 1-year high of $2.49 and a 1-year low of $0.59. The stock’s 50-day moving average is $1.86 and its 200-day moving average is $1.30.

On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on June 14, FBR analyst Vernon Bernardino reiterated a Buy rating on GALE, with a price target of $5, which implies an upside of 146% from current levels. Separately, on June 7, Maxim Group’s Jason McCarthy reiterated a Buy rating on the stock and has a price target of $4.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Jason McCarthy have a total average return of -14.8% and 0.2% respectively. Bernardino has a success rate of 27.3% and is ranked #3850 out of 3980 analysts, while McCarthy has a success rate of 35.6% and is ranked #2099.

Galena Biopharma, Inc. engages as a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. It focuses on identifying and advancing therapeutic opportunities to improve cancer care from direct treatment of the disease to the reduction of its debilitating side effects. Its products include Abstral (fentanyl) sublingual tablets and Zuplenz (ondansetron) oral soluble film.