Biostage secures FDA orphan drug designation
PHOTO/LAURA FINALDI
Biostage CEO Jim McGorry (left) and Chief Medical Officer Saverio La Francesca hold one of the company's synthetic scaffolds that have worked to regrow esophaguses in pigs.
Bioengineered organ transplant company Biostage’s stock lept more than 25 percent after the company announced it received a designation that will save the company time and money as it pushes its throat transplant technology to the market.
The announcement was made Thursday that its Cellspan Esophageal Implant was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities.
The leap in stock prices that followed took the company’s stock back above the important $1 mark, which it had fallen below and prompted a delisting warning from NASDAQ.
The three-year-old Holliston company will be able to benefit from the designation through a $672,000 IND application fee waiver as well as a seven-year marketing exclusivity period against competition upon marketing approval and tax credits.
Biostage has been pushing to get this technology through the FDA’s process even as it has been forced to seek new funds after pushing back the start date of its human trials of the technology per the FDA’s advisement.
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