What: Galena Biopharma was up 18% at 1:20 p.m. EDT after announcing this morning that the Food and Drug Administration gave a Fast Track designation to the biotech's NeuVax breast cancer drug.
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So what: Galena is testing NeuVax in combination with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF) in patients with early stage breast cancer that have low to intermediate expression of a protein called HER2. Tumors with high expression of HER2 are treated with drugs like Roche's Herceptin or Kadcyla, but those with low to intermediate HER2 expressions have fewer options to prevent recurrence.
The phase 3 trial, called PRESENT, compares NeuVax plus GM-CSF to GM-CSF alone. The clinical trial started in 2012 and isn't scheduled to be completed until 2018. The clinical trial took a while to enroll, but the main reason it's taking so long is because Galena has to follow these patients for three years to measure whether the breast cancer returns.
PRESENT is halfway through the number of qualifying events -- breast cancer returning in either the treatment or control group -- so the independent data monitoring board will look at the interim data shortly. Sometimes these trials have interim peeks that can stop the trial early if it's clear the drug is working better than the control group, but Galena's interim peek is only designed to stop the trial if there's a safety issue or if it's clear NeuVax isn't working.
Now what: The Fast Track designation can help drugs get approved quicker because it allows for more interaction with the FDA, the possibility to submit parts of the application as they're completed, and the potential for a priority review that shaves four months off the review time.
While getting Fast Track is a positive for Galena, it's pretty easy to get the designation, and it certainly isn't an endorsement of whether the FDA thinks NeuVax will eventually get approved. The designation says more about the disease the drug is treating -- life-threatening with need for more treatment options -- than it does about the drug.
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Long-term investors can ignore today's overzealous excitement about the Fast Track designation because it won't affect Galena's ultimate value that will be determined by the outcome of the PRESENT trial.