Lisata Secures EMA Waiver for Pancreatic Cancer Treatment

Clinical stage pharmaceutical company, Lisata Therapeutics, Inc. (Nasdaq: LSTA), has reached an agreement with the European Medicines Agency (EMA) on a Pediatric Investigation Plan for Lisata’s lead investigational product, certepetide, in pancreatic cancer. The EMA has agreed to a product-specific full pediatric waiver for certepetide in pancreatic cancer, on the grounds that pancreatic cancer occurs only in adults. Lisata’s share price has seen a 17.74% increase since the announcement on Monday.

The waiver removes any requirement for Lisata to conduct clinical studies of certepetide in children in support of an overall marketing authorization application in Europe for pancreatic cancer, significantly reducing the clinical trial burden and overall cost of completing development and achieving market registration in Europe.

Commenting on the news, Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata, said “We are pleased that the European Medicines Agency has confirmed that pediatric studies evaluating certepetide are not needed to support a market authorization application in pancreatic cancer. With a waiver in hand, we are now able to streamline our development program as we work toward certepetide’s product registration in Europe. This full waiver is specific to pancreatic cancer and will not affect our commitment to evaluate certepetide in other pediatric solid tumors as required.”

Certepetide (formerly 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. It has demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer.

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, certepetide (formerly LSTA1), is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next two years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For more information on the Company, please visit www.lisata.com.

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Lisata Secures EMA Waiver for Pancreatic Cancer Treatment

Catie Corcoran

Biotech Editor