Nuvectis Gets FDA Orphan Designation for NXP800 in Cholangiocarcinoma

By Colin Kellaher

Nuvectis Pharma has won a key U.S. Food and Drug Administration designation for its proposed treatment for a rare but aggressive form of bile-duct cancer.

The clinical-stage biopharmaceutical company on Thursday said the FDA granted orphan-drug designation to NXP800 for the treatment of cholangiocarcinoma.

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.

Nuvectis said cholangiocarcinoma accounts for about 3% of all gastrointestinal malignancies, with an annual incidence of 8,000 to 10,000 in the U.S.

The company is currently studying the clinical activity of NXP800 in a Phase 1b trial in patients with platinum resistant, ARID1a-mutated ovarian carcinoma.

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

(END) Dow Jones Newswires

August 17, 2023 08:41 ET (12:41 GMT)

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