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- Nuvectis Pharma (NASDAQ:NVCT) added ~7% in the premarket on Thursday after the cancer drug developer announced that the U.S. FDA offered its orphan drug designation for NXP800, one of its clinical-stage assets targeted at a type of ovarian tumor.
- Specifically, the FDA has issued the orphan drug designation for investigations of NXP800 into ARID1a (f AT-rich interactive domain-containing protein 1a)-deficient ovarian, fallopian tube, and primary peritoneal cancers.
- With its orphan drug designation, the FDA aims to offer financial incentives to drug developers who develop drugs for rare diseases and conditions.
- In addition to tax credits for clinical trial costs and a user fee waiver for marketing applications, the developers can claim up to seven years of U.S. marketing exclusivity.
- NXP800 is currently undergoing a Phase 1b trial in patients with platinum-resistant, ARID1a-mutated ovarian cancer, with a data update from the study expected this fall.
