Orgenesis shares soar 19% premarket as FDA gives orphan status to insulin tech
Orgenesis Inc. shares ORGS, -1.83% soared 19% in premarket trade Monday, after the U.S. Food and Drug Administration granted Orphan Drug Designation to the company's Autologous Insulin Producing cells as a cell replacement therapy for the treatment of severe hypoglycemia-prone diabetes resulting from total pancreatectomy, caused by chronic pancreatitis.
Orgenesis has an exclusive license for the technology from Israel's Tel Hashomer Medical Research Infrastructure and Services Ltd., that is based on the work of Professor Sarah Ferber, the company's chief scientific officer and a researcher at THM. Patients who have total pancreatectomy always suffer from diabetes, which results in lifelong insulin-dependence with the loss of endogenous insulin secretion and that of the counter-regulatory hormone, glucagon.
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