Galena Biopharma Inc (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has designated NeuVax™ (nelipepimut-S), combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), as a Fast Track development program for the treatment of patients with early stage, node positive breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, following standard of care. Galena’s PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial is an international, Phase 3 study to evaluate NeuVax plus GM-CSF versus placebo plus GM-CSF to prevent cancer recurrence.
“This Fast Track designation by the FDA reflects the importance of NeuVax as a potential treatment option addressing an unmet medical need in a serious medical condition,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “With the number of cancer survivors in the United States projected to increase by 31% to almost 19 million by 20241, there is a clear need to prevent recurrence in women with breast cancer who have completed their standard of care, but have limited therapies to maintain their disease free status. As we approach our interim safety and futility analysis for PRESENT, and initiate our efforts towards the filing of a Biologics License Application (BLA), this Fast Track designation will be extremely valuable to us as we seek marketing authorization for NeuVax.”
“Fast Track designation provides us with opportunities for frequent interactions with the FDA review team for our NeuVax development program in breast cancer, including the PRESENT trial, as we prepare our BLA for filing. As such, assuming a successful clinical readout in the PRESENT trial, we may be eligible for a rolling review. We look forward to collaborating closely with the FDA at this critical stage for NeuVax development,” added Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer.
The Fast Track designation provides for the designation of a drug as a fast track product if it is intended for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.2 This designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.3 Designation as a Fast Track product means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. If FDA determines, after preliminary evaluation of clinical data submitted by a sponsor, that a fast track product may be effective, the Agency may consider reviewing portions of a marketing application before the sponsor submits the complete application (rolling review).4 In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA submission. (Original Source)
Shares of Galena Biopharma are up nearly 8% to $1.95 in pre-market trading. GALE has a 1-year high of $2.39 and a 1-year low of $0.59. The stock’s 50-day moving average is $1.45 and its 200-day moving average is $1.21.
On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on May 16, FBR analyst Vernon Bernardino reiterated a Buy rating on GALE, with a price target of $5, which implies an upside of 176.2% from current levels. Separately, on March 14, Roth Capital’s Joseph Pantginis reiterated a Buy rating on the stock and has a price target of $5.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Joseph Pantginis have a total average return of -15.6% and 0.2% respectively. Bernardino has a success rate of 33.3% and is ranked #3864 out of 3891 analysts, while Pantginis has a success rate of 37.7% and is ranked #2067.
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.