Candel Therapeutics Gets FDA's Orphan-Drug Status for Glioma Treatment

By Dean Seal

Candel Therapeutics said regulators have granted orphan-drug designation to its CAN-3110 drug candidate as a treatment for recurrent high-grade glioma, an aggressive brain tumor.

The Needham, Mass., clinical-stage biopharmaceutical company said Thursday that the U.S. Food and Drug Administration's designation provides CAN-3110 with certain developmental financial incentives and, if approved, potentially up to seven years of marketing exclusivity in the U.S.

Orphan-drug designation is a special status given to drugs that show promise for potentially treating rare, or orphan, diseases that have fewer than 200,000 cases a year in the U.S.

CAN-3110 was previously granted the FDA's fast-track designation to expedite its development and review.

Write to Dean Seal at [e-mail]

(END) Dow Jones Newswires

05-30-24 0845ET