Lantern Pharma Gets Three FDA Rare-Pediatric Designations for LP-184

By Colin Kellaher

Lantern Pharma has won a trio of rare-pediatric-disease designations from the Food and Drug Administration for its investigational drug candidate LP-184 in multiple ultra-rare children's cancers.

Lantern on Monday said the designations cover LP-184 in malignant rhabdoid tumors, rhabdomyosarcoma and hepatoblastoma.

The FDA grants rare-pediatric-disease designation to drugs aimed at serious or life-threatening diseases that affect fewer than 200,000 people in the U.S. and primarily affect those ages 18 years and younger.

The agency awards priority-review vouchers to companies upon approval of certain drugs that are granted the designation, and those vouchers can be used to obtain priority review for another drug or sold to other companies.

Lantern, a Dallas clinical-stage biotechnology company, said LP-184 is currently in a multi-center Phase 1A clinical trial that is expected to enroll 50 to 60 patients across a range of solid tumors.

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

(END) Dow Jones Newswires

September 23, 2024 08:54 ET (12:54 GMT)

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