Candel Therapeutics Shares Leap Premarket on FDA Orphan-Drug Designation

By Colin Kellaher

Shares of Candel Therapeutics jumped nearly 30% in premarket trading Thursday after the clinical-stage biopharmaceutical company won a key U.S. Food and Drug Administration designation for the lead product candidate from the adenovirus platform.

Candel said the FDA granted orphan-drug designation to CAN-2409 for the treatment of pancreatic cancer.

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.

Candel recently reported Phase 2 study data showing that CAN-2409, when added to standard of care, more than doubled the median overall survival obtained with standard of care alone in borderline resectable pancreatic cancer.

The Needham, Mass., company last year won FDA fast-track designation for CAN-2409 in pancreatic cancer.

Candel shares, which closed Wednesday at $5.10, were recently up 29% to $6.59 in premarket trading.

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

(END) Dow Jones Newswires

April 11, 2024 09:30 ET (13:30 GMT)

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