Galena Biopharma Inc. (NASDAQ:GALE), stock surged almost 26% in pre-market trade Wednesday after the company announced its GALE-401 drug would enter a phase 3 trial.
During the publication Galena Biopharma Inc(NASDAQ:GALE) said it had a “productive” meeting with the Food and Drug Administration endorsing that the drug and clinical trial were appropriate for a new drug filing with the regulator.
Meanwhile GALE-401 is being established to treat vital thrombocythemia, a rare blood syndrome.
Furthermore the Phase 3 clinical trial will register patients with essential thrombocythemia who have either unsuccessful or are intolerant to hydroxyurea, and will compare GALE-401 to the best available therapy (BAT) that will comprise a sizable subpopulation of patients treated with anagrelide instant release. The company said in a statement that the phase 3 trial is scheduled to start during the second quarter of 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.”
Moreover Galena Biopharma (GALE) stock have plunged 93.3% year-to-date, in contrast with a 11.0% rise in the S&P 500 Galena shares were valued at $1.96 as of Tuesday’s close.