NetworkNewsBreaks – Biostage (BSTG) Shares Soar after FDA Grants Cellspan™ Esophageal Implant Orphan Drug Designation
Biostage, Inc. (NASDAQ: BSTG) is trading 30% higher following news that the company’s Cellspan™ Esophageal Implant was granted Orphan Drug Designation to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities. This designation provides for a seven-year marketing exclusivity period against competition upon marketing approval, as well as certain incentives, including tax credits and a waiver of PDUFA filing fees. Biostage said it expects to file its IND in the third quarter of 2017 followed by its phase 1 first-in-human clinical study in the fourth quarter of 2017. "We believe…







