Does Saltikva have FDA Orphan Drug Designation?

The FDA Orphan Drug Designation database lists the attenuated Salmonella typhimurium containing the gene for human interleukin-2 for the treatment of pancreatic cancer (designated 2022-05-17) and for the treatment of osteosarcoma (designated 2025-11-19), both with Salspera, Inc. (developer of Saltikva) as sponsor and both marked not FDA approved for the orphan indication. An Orphan Drug Designation is not a finding that a product works or is approved.