Lisata Receives FDA Orphan Drug Designation For LSTA1 To Treat Osteosarcoma

(RTTNews) - Lisata Therapeutics, Inc. (LSTA) announced on Tuesday that it has received an orphan drug designation from the FDA for LSTA1, the company's primary product candidate, to treat osteosarcoma, a rare form of bone cancer that can occur in young individuals.

The orphan drug designation is set to allow a seven-year exclusive marketing period after approval, along with exemption from user fees and eligibility for tax credits for applicable clinical trials.

LSTA1 has previously obtained orphan drug designation for pancreatic cancer in the U.S. and Europe, as well as for glioblastoma multiforme and osteosarcoma in the U.S. Moreover, it secured a Fast Track designation for pancreatic cancer and, on March 21, 2024, a Rare Pediatric Disease designation for osteosarcoma from the FDA.