Investors in Galena Biopharma Inc (NASDAQ:GALE) are having a great morning today. Galena shares are up over 50% after the biotech company announced that the independent Data Safety Monitoring Board (DSMB), which provides oversight for the company’s breast cancer combination treatment, reviewed the safety data from the ongoing two mid-stage trials and informed the Company that it has identified no safety concerns, and recommended the continuation of the studies.
“The recommendations from the DSMB are very positive for NeuVax in combination with trastuzumab as there were no safety concerns and the studies were not deemed futile. Given these findings, the trials can continue per the DSMB recommendation,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “We are also pleased that we will be able to reach the interim efficacy analysis in our Phase 2b HER2 1+/2+ trial earlier than expected with that readout now planned by the end of this year. It is important to note that these IST trials are designed with a different methodology to identify recurrences clinically and not via proactive imaging as was done in the PRESENT trial. We are grateful to our investigators running these trials and their continued dedication to breast cancer patients as they study potential new therapeutic options to prevent recurrence.”
In his recent research report, Maxim Jason McCarthy noted, “From a clinical perspective, we believe that NeuVax and GALE-401 have potential in breast cancer and essential thrombocythemia (ET), respectively. However, from a corporate perspective, the uncertainty about the company’s future and no visibility on timing around resolution of these issues, we believe it is prudent to downgrade the shares to Hold.”
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy has a yearly average loss of -17.2% and a success rate of 34%. McCarthy is ranked #4306 out of 4374 analysts.
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.