Galena Biopharma Inc (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that the Independent Data Monitoring Committee (IDMC) has recommended to the Company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial. The trial is being run under a Special Protocol Assessment (SPA) approved by the U.S. Food and Drug Administration (FDA).
Following its most recent IDMC meeting in June 2015, the IDMC recommended routine cardiac monitoring could be reduced in the PRESENT trial and that such a reduction is justified and consistent with the pre-specified Cardiac Toxicity Monitoring Stopping Rules defined in the study protocol. The IDMC concluded that cardiac toxicity monitoring by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans could be reduced. The IDMC had no other suggestions and recommended the trial continue as planned.
Mark W. Schwartz, Ph.D., President and Chief Executive Officer, stated, “We are pleased to see that cardiac events have not appeared as a safety issue thus far in the study, relative to published reports of cardiac toxicity associated with other HER2 directed therapies. Importantly, the recommendation by the IDMC to reduce the frequency of cardiac assessments, per the protocol, facilitates the ongoing compliance and patient retention on trial.”
Per the PRESENT protocol, the IDMC was established and is made up of a group of physicians including medical oncologists, a cardiologist, and an independent statistician with pertinent expertise to evaluate accumulated data from the trial. The IDMC meets periodically and advises Galena regarding the continuing safety of trial patients, efficacy, as well as the continuing validity, integrity, and the overall conduct of the trial. (Original Source)
Shares of Galena Biopharma closed last Friday at $1.34. GALE has a 1-year high of $2.63 and a 1-year low of $1.27. The stock’s 50-day moving average is $1.60 and its 200-day moving average is $1.60.
On the ratings front, Galena Biopharma has been the subject of a number of recent research reports. In a report issued on August 7, MLV & Co. analyst Vernon Bernardino reiterated a Buy rating on GALE, with a price target of $5, which implies an upside of 273.1% from current levels. Separately, on the same day, Cantor Fitzgerald’s Mara Goldstein reiterated a Sell rating on the stock and has a price target of $2.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Mara Goldstein have a total average return of -19.0% and 7.8% respectively. Bernardino has a success rate of 18.2% and is ranked #3709 out of 3737 analysts, while Goldstein has a success rate of 48.3% and is ranked #657.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $7.00 which is 422.4% above where the stock closed last Friday.
Galena Biopharma Inc, is abiopharmaceutical company focused on developing and commercializing targeted oncology therapeutics that address medical needs across the full spectrum of cancer care.