NORCROSS, Ga. (AP) -- Shares of Galectin Therapeutics jumped Monday morning after the drug developer said that its liver disease treatment, now in early-stage clinical testing, received fast track designation from regulators.
THE SPARK: The Norcross, Ga., company said that the Food and Drug Administration granted the fast track status to a compound labeled GR-MD-O2 that aims to treat fatty liver disease with advanced fibrosis.
THE BACKGROUND: Galectin said the compound showed "robust treatment effects in reversing fibrosis and cirrhosis" in pre-clinical data.
That research normally involves laboratory testing in cells and animals.
Galectin is conducting early-stage testing in humans to evaluate, in part, safety and how well patients tolerate the drug.
The FDA's fast track designation is designed to speed up the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
The status gives companies extra meetings and correspondence with regulators through the review process, and it allows the drugmaker to submit data as it compiles it.
SHARE ACTION: Galectin Therapeutics Inc. rose more than 29 percent, or $1.63, to $7.20 in midmorning trading. The shares reached $7.95 earlier in the session, their highest price since 2011. The stock also has traded as low as $1.60 over the past year.