Lisata’s Bone Cancer Candidate Receives Orphan Drug Designation
Lisata Therapeutics (Nasdaq: LSTA) has received FDA Orphan Drug Designation for LSTA1, its lead product candidate, for the treatment of osteosarcoma. Osteosarcoma is a rare cancer that can develop in children, adolescents and young adults. Approximately 800 cases are diagnosed in the US each year. The company’s share price rose more than 10% in morning trading on Tuesday following the news.
Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata, commented on the news, saying, “We are thrilled to have received another favorable regulatory designation from the FDA. This underscores the significant unmet medical need and demand for better treatments for patients diagnosed with osteosarcoma.
“Osteosarcoma, while rare, is a type of bone cancer that is often associated with high morbidity, early metastasis, rapid progression, and poor prognosis. Receiving an ODD from the FDA is an important milestone as we plan for future clinical expansion of LSTA1, and we believe it reflects the broad clinical utility of LSTA1 for the treatment of a wide array of solid tumors.”
In March, the company received Rare Pediatric Disease Designation for LSTA1 in osteosarcoma.
LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 also has the potential to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies.
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead product candidate, LSTA1, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Based on Lisata’s CendR Platform® Technology, Lisata has already established noteworthy commercial and R&D partnerships. The Company expects to announce numerous clinical study and business milestones over the next two years and has projected that its current business and development plan is funded with available capital through these milestones and into early 2026. For more information on the Company, please visit www.lisata.com.
