Galena Biopharma Inc (NASDAQ:GALE) announced the Company has confirmed the regulatory pathway to advance GALE-401 (Anagrelide Controlled Release) into a pivotal, Phase 3 trial. After a productive meeting with the U.S. Food and Drug Administration (FDA), the Company has confirmed the development program and proposed clinical trial are appropriate for a New Drug Application (NDA) filing using the 505(b)(2) regulatory pathway.
The Phase 3 clinical trial will enroll patients with essential thrombocythemia who have either failed or are intolerant to hydroxyurea, and will compare GALE-401 to the best available therapy (BAT) that will include a sizable subpopulation of patients treated with anagrelide immediate release. The Company expects to finalize the Phase 3 clinical trial protocol and initiate the trial in Q2, 2017.
“Confirmation of the 505(b)(2) regulatory pathway and preliminary agreement with the Agency on our Phase 3 clinical trial design is a significant step forward for our late stage program,” Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “Our controlled release version of anagrelide can offer a potential treatment option for patients with ET who have failed hydroxyurea. We remain on track to initiate the trial in the second quarter of 2017.” (Original Source)
Shares of Galena Biopharma closed yesterday at 1.96, down $0.02 or -1.01%. GALE has a 1-year high of $49.80 and a 1-year low of $1.84. The stock’s 50-day moving average is $2.46 and its 200-day moving average is $1.04.
On the ratings front, Galena Biopharma has been the subject of a number of recent research reports. In a report issued on December 2, FBR analyst Vernon Bernardino reiterated a Buy rating on GALE, with a price target of $11, which implies an upside of 461% from current levels. Separately, on November 10, Maxim Group’s Jason McCarthy reiterated a Buy rating on the stock and has a price target of $1.
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 yearly average loss of -18.8% and -19.7% respectively. Bernardino has a success rate of 21% and is ranked #4223 out of 4295 analysts, while McCarthy has a success rate of 21% and is ranked #4221.
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.