Shares of Galena Biopharma Inc (NASDAQ:GALE) ended Thursday session in green amid volatile trading. The shares closed up +0.003 points or 0.76% at $0.333 with 4.23 million shares getting traded. Post opening the session at $0.33, the shares hit an intraday low of $0.31 and an intraday high of $0.34 and the price vacillated in this range throughout the day. The company has a market cap of $70.70 million and the numbers of outstanding shares have been calculated to be 213.97 million shares.
Galena Biopharma Inc (GALE) on Sept. 12, 2016 announced the issuance of a second Japanese Patent (JP Patent #5985719) containing composition and method of use claims for GALE-401, the Company’s controlled release version of anagrelide. The patent covers the treatment of patients suffering from myeloproliferative diseases, including myeloproliferative neoplasms (MPNs) such as essential thrombocythemia (ET) and polycythemia vera. The patent provides GALE-401 exclusivity until 2029, not including any patent term extensions.
“With our plans to initiate a Phase 3 trial next year in essential thrombocythemia, we are looking to position GALE-401 as a potential treatment option for MPN patients worldwide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “This Japanese patent further expands our international intellectual property (IP) position complementing our IP estate in the United States. Branded anagrelide immediate release was approved in Japan in 2014.
GALE-401 contains the active ingredient anagrelide. The currently available immediate release formulation (Agrylin® or anagrelide IR) is approved in the U.S., Europe and Japan for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis, and to ameliorate associated symptoms including thrombo-hemorrhagic events. Adverse events associated with anagrelide IR, such as nausea, diarrhea, abdominal pain, palpitations, tachycardia, and headache, may be dose and plasma concentration dependent. GALE-401 is a controlled release formulation of anagrelide, which significantly reduces the maximum plasma concentration (Cmax), and is expected to reduce side effects, but preserve efficacy. A Phase 2 pilot study with GALE-401 has been completed and Galena expects to launch a Phase 3 trial in the first half of 2017.
Shares of bluebird bio Inc (NASDAQ:BLUE) ended Thursday session in green amid volatile trading. The shares closed up +7.15 points or 11.37% at $70.04 with 4.20 million shares getting traded. Post opening the session at $65.81, the shares hit an intraday low of $65.18 and an intraday high of $71.61 and the price vacillated in this range throughout the day. The company has a market cap of $2.58 billion and the numbers of outstanding shares have been calculated to be 37.17 million shares.
bluebird bio Inc (BLUE) on September 8, 2016 announced the opening of HGB-207, a Phase 3, global, multi-center study in patients with transfusion-dependent beta-thalassemia with non-β0/β0 genotypes. This study will incorporate the addition of bluebird bio’s transduction enhancers to the hematopoietic stem cell (HSC) manufacturing process, and will be conducted under the same Investigational New Drug application (IND) as previous studies of LentiGlobin in beta-thalassemia.
“The opening of bluebird’s first Phase 3 study for LentiGlobin, in which we are using an improved manufacturing process that increases transduction efficiency, is an exciting step forward,” said David Davidson, M.D., chief medical officer, bluebird. “The accumulating clinical data show a correlation among vector copy number, the percentage of vector-containing cells, and the amount of hemoglobin produced by patients treated with LentiGlobin. We believe that the addition of our transduction enhancers to our manufacturing process has the potential to substantially increase the hemoglobin levels in patients with transfusion dependent beta-thalassemia and increase their likelihood of achieving clinically meaningful reductions in transfusion requirements or transfusion independence, the ultimate goal of our therapy.”