NEW YORK (TheStreet) -- Galena Biopharma (GALE) stock spiked by 19.33% to $2.16 on heavy trading volume in Wednesday's trading session, after the FDA gave its breast cancer treatment NeuVax a Fast Track designation.
The biopharmaceutical company is testing NeuVax in combination with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF) in patients with early stage breast cancer with a low to intermediate expression of a protein called HER2.
The phase three trial, named PRESENT, isn't scheduled to be completed until 2018.
Fast Track designation can help promising drugs intended for the treatment of a serious condition receive approval more quickly by allowing further interaction with the FDA. The designation also allows companies to submit portions of the application as they're completed and grants them the potential for a priority review that cuts down the review time by four months.
About 26.56 million shares of Galena were traded today, well above its average trading volume of roughly 1.77 million shares per day.