LISATA THERAPEUTICS, INC. Lisata Therapeutics, Inc. announced that the U.S. Food and Drug Administration (the ?FDA?) has granted Orphan Drug Designation (?ODD?) to LSTA1, the Company?s lead product candidate, for the treatment of osteosarcoma, a rare cancer that can develop in children, adolescents and young adults. LSTA1 recently received Rare Pediatric Disease Designation for osteosarcoma, as announced by the Company on March 21, 2024. Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States.
The designation can provide for a seven-year window of exclusive marketing rights post-approval as well as exemption from user fees and eligibility for tax credits for qualified clinical trials. In addition to the financial benefits, it also may potentially shorten clinical development due to closer collaboration with the FDA.
