Lisata Therapeutics, Inc. (LSTA) released a statement on Tuesday declaring that it has been granted an Orphan Drug Designation by the Food and Drug Administration (FDA) for its chief product candidate, LSTA1. This drug is earmarked for the treatment of osteosarcoma, a relatively rare type of bone cancer frequently found in young people.
The Orphan Drug Designation assures Lisata Therapeutics of an exclusive seven-year marketing period upon FDA approval. Additionally, it includes exemptions from user fees and a qualification for tax credits relevant to clinical trials.
Prior to this, LSTA1 was already recognized as an orphan drug for pancreatic cancer in both the United States and Europe. It also received this status for osteosarcoma as well as glioblastoma multiforme in the US. Moreover, Lisata Therapeutics secured a Fast Track designation for pancreatic cancer, and by March 21, 2024, it was awarded a Rare Pediatric Disease designation for osteosarcoma by the FDA.
