Stock Update (NASDAQ:GALE): Galena Biopharma Inc Receives Two Orphan Drug Designations for GALE-301 and GALE-301/GALE-302

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 granted two orphan-drug designations for Galena’s two cancer immunotherapy peptides derived from Folate Binding Protein (FBP) for the treatment (including prevention of recurrence) of ovarian cancer: one for GALE-301 (E39), and one for GALE-301 (E39) and GALE-302 (E39’). In clinical trials, GALE-301, and GALE-301/GALE-302 are combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the treatment of ovarian cancer in the adjuvant setting.

“Ovarian cancer is a very aggressive disease with almost fifty percent of women recurring within five years after their initial treatment1,” saidMark W. Schwartz, Ph.D., President and Chief Executive Officer.  “This designation supports our efforts to advance our FBP-targeted immunotherapy program consisting of GALE-301 and GALE-302 to prevent cancer recurrence in this underserved patient population.”

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.2 Orphan designation qualifies the sponsor of the drug for various development incentives including marketing exclusivity in the U.S. for seven years after product approval3, tax credits, and exemption from the prescription drug user fee. (Original Source)

Shares of Galena are currently trading at $2.09, up $0.11 or 5.30%. GALE has a 1-year high of $2.29 and a 1-year low of $0.59. The stock’s 50-day moving average is $1.56 and its 200-day moving average is $1.24.

On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on June 7, Maxim Group analyst Jason McCarthy reiterated a Buy rating on GALE, with a price target of $4, which represents a potential upside of 95% from where the stock is currently trading. Separately, on June 3, FBR’s Vernon Bernardino reiterated a Buy rating on the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Vernon Bernardino have a total average return of 9.6% and -11.9% respectively. McCarthy has a success rate of 55% and is ranked #351 out of 3903 analysts, while Bernardino has a success rate of 35% and is ranked #3854.

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. 

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