FDA grants orphan drug designation to Orgenesis’ insulin therapy

Orgenesis (NASDAQ:ORGS) +6.7% pre-market on news that the Food and Drug Administration granted Orphan Drug designation for its Autologous Insulin Producing cells as a cell replacement therapy for the treatment of severe hypoglycemia-prone diabetes resulting from total pancreatectomy due to chronic pancreatitis.

The technology is exclusively licensed by the company’s wholly-owned Israeli subsidiary from Tel Hashomer Medical Research Infrastructure and Services and is based on the work the company’s Chief Scientific Officer, who also is a researcher at THM.

ORGS says its patented transdifferentiation (or cell reprogramming) process involves the conversion of one adult tissue or cell into another type of cell, with its distinct phenotype and function; the company’s therapy utilizes its transdifferentiation process and its Point of Care liver expansion technology to transform liver cells into AIP cells.

https://seekingalpha.com/news/3471688-fda-grants-orphan-drug-designation-orgenesis-insulin-therapy