NEW YORK (TheStreet) -- Galena Biopharma (GALE) stock is soaring by 22.65% to $2.22 on heavy trading volume late Wednesday morning, after the FDA designated its NeuVax (nelipepimut-S) treatment, combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), for Fast Track development.
The treatment is meant for patients with early stage, node positive breast cancer with low to intermediate HER2 expression, according to a company statement.
Fast Track designation is granted if a product is intended for the treatment of a serious disease or condition and demonstrates the potential to address unmet medical needs. The FDA will expedite the development and review of the application for approval for such a product.
"Fast Track designation provides us with opportunities for frequent interactions with the FDA review team for our NeuVax development program in breast cancer, including the PRESENT trial, as we prepare our BLA for filing," Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer, said in a statement.
About 15.61 million shares of Galena have been traded so far today, well above the company's average trading volume of roughly 1.77 million shares per day.