- Lantern Pharma ( NASDAQ: LTRN ) on Thursday said the U.S. Food and Drug Administration (FDA) had granted an orphan drug designation to its LP-284 candidate for the treatment of mantle cell lymphoma (MCL).
- MCL is a rare and aggressive form of B-cell non-Hodgkin's lymphoma that is typically diagnosed at advanced stages in elderly patients.
- LTRN's LP-284 is a small molecule agent that preferentially damages DNA in cancer cells harboring mutations in DNA damage repair pathways.
- The FDA's orphan drug designation program expedites the development and evaluation of a drug or biological product to prevent a rare disease or condition.
- LTRN anticipates filing an investigational new drug application with the FDA for an early-stage trial of LP-284 by mid-2023, the company said in a statement .
- Lantern ( LTRN ) stock was -7.5% to $5.70 in early trade.
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FDA grants orphan drug designation to Lantern Pharma's lymphoma treatment candidate