Lisata Therapeutics’ Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma
Friday, September 06, 2024
Lisata Therapeutics, Inc., a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to certepetide for the treatment of cholangiocarcinoma.
“Cholangiocarcinoma is a rare and aggressive form of cancer that presents a significant challenge for patients due to limited treatment options, especially after initial therapy,” said Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. “Receiving Orphan Drug Designation for our investigational product, certepetide, is a pivotal step toward addressing the unmet need for cholangiocarcinoma therapies and providing patients with new, innovative treatment options.”
Lisata is currently evaluating certepetide in its BOLSTER trial, a Phase 2a double-blind, placebo-controlled, multi-center, randomized study in the U.S. for the treatment of first- and second-line cholangiocarcinoma. For more information on the trial, please visit https://www.lisata.com/bolster-clinical-trials/.
Source: globenewswire.com
