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Biostage Files Orphan Drug Status For Cellspan Esophageal Implant With FDA


Biostage, Inc. (NASDAQ: BSTG) disclosed that it submitted an application with the Food and Drug Administration seeking orphan drug status for its Cellspan Esophageal Implants. The company indicated that the Orphan Drug Act of 1983 offered a range of incentives to encourage research and development investment in treatments for rare medical conditions.

Biostage CEO, Jim McGorry, stated, "This submission is the first step in our effort to secure orphan status for our Cellspan esophageal implant, which we believe has the potential to be a valuable option in the treatment of esophageal cancer. The Biostage team is executing on the key initiatives required to advance into human clinical trials for our esophageal implant product candidate, and we remain on track with our plan to conclude its pre-clinical development, to publish our large-animal study results and to execute our related Good Laboratory Practices (GLP) studies during Q3 and into Q4."

McGorry added, "Our plan and goal is to file an Investigational New Drug application (IND) with the FDA by the end of the current year. Assuming approval on a normal time-frame, we believe that by this time next year our Cellspan esophageal implant should be in a human clinical pilot study."

On Wednesday, the stock traded down by 3.5 percent.

Posted-In: Biotech News FDA General


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