By Colin Kellaher

 

Theseus Pharmaceuticals Inc. on Wednesday said the U.S. Food and Drug Administration granted orphan-drug designation to THE-630, the company's lead candidate for the treatment of patients with advanced gastrointestinal stromal tumors, or GIST.

The Cambridge Mass., clinical-stage biopharmaceutical company recently initiated a first-in-human study of THE-630 in GIST, the most common sarcoma of the gastrointestinal tract, with an estimated 4,000 to 6,000 new cases diagnosed in the U.S. each year.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

February 02, 2022 07:57 ET (12:57 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
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