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EMA grants waiver for Lisata's pediatric pancreatic cancer studies

EditorNatashya Angelica
Published 05/21/2024, 12:06 AM
LSTA
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BASKING RIDGE, N.J. - Lisata Therapeutics, Inc. (NASDAQ:LSTA), a clinical-stage pharmaceutical company, has announced that the European Medicines Agency (EMA) has granted a pediatric waiver for their lead investigational product, certepetide, in pancreatic cancer. This waiver from the EMA's Paediatric Committee (PDCO) implies that Lisata is not required to conduct clinical trials in the pediatric population for pancreatic cancer, which is known to occur only in adults.

The decision allows Lisata to streamline its development program for certepetide, potentially accelerating the drug's path to market registration in Europe. Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Lisata, expressed satisfaction with the EMA's confirmation, emphasizing the company's continued efforts to evaluate certepetide for other pediatric solid tumors as required.

Certepetide is designed to enhance the delivery of co-administered anti-cancer drugs into solid tumors and has received Fast Track designation in the U.S. for pancreatic cancer. It has also been granted Orphan Drug Designation for pancreatic cancer in both the U.S. and E.U., as well as for glioma and osteosarcoma in the U.S. Moreover, it has been awarded Rare Pediatric Disease Designation for osteosarcoma in the U.S.

The Paediatric Regulation, established by the European Union in 2007, requires companies to obtain data from studies in children to support the authorization of medicines for pediatric use. However, the PIP waiver is granted when the development of a medicine for children is not feasible or appropriate.

Lisata Therapeutics focuses on the development of therapies for advanced solid tumors and other serious diseases. Its CendR Platform® technology has led to commercial and R&D partnerships, and the company expects to announce key milestones in the coming years. Lisata anticipates that its current capital will sustain operations into early 2026, covering expected data milestones from ongoing and planned clinical trials.

This news is based on a press release statement from Lisata Therapeutics. The company's forward-looking statements involve risks and uncertainties, and there is no assurance that certepetide will prove safe or effective for the treatment of pancreatic cancer or any other solid tumors.

InvestingPro Insights

Lisata Therapeutics, Inc. (NASDAQ:LSTA) has recently been in the spotlight due to its regulatory advancements in Europe, which could have a significant impact on the company's development timeline and market potential for its lead investigational product, certepetide. An analysis of the company's financial health and market performance may provide additional context for investors considering the implications of this news.

InvestingPro Data reveals a market capitalization of 23.01M USD for Lisata, reflecting the company's current valuation in the market. Despite the company's promising advancements in the pharmaceutical field, the data indicates a negative P/E ratio of -1.11 and an adjusted P/E ratio for the last twelve months as of Q1 2024 of -1.15, suggesting that the company has not been profitable over this period.

This aligns with the InvestingPro Tips that analysts do not anticipate the company will be profitable this year and that it has not been profitable over the last twelve months. Moreover, Lisata's price has performed poorly over the last decade, with a 1 Year Price Total Return as of Y2024.D141 of -32.44%.

On the positive side, Lisata holds more cash than debt on its balance sheet, which can be a sign of financial stability. Furthermore, the company's liquid assets exceed its short-term obligations, indicating a healthy liquidity position that could support its ongoing and planned clinical trials. Still, it is worth noting that Lisata does not pay a dividend to shareholders, which could be a consideration for income-focused investors.

For readers interested in a deeper dive into Lisata's financial metrics and investment potential, there are additional InvestingPro Tips available at https://www.investing.com/pro/LSTA. These tips could provide further insights into the company's performance and outlook. Also, if you're considering an InvestingPro subscription, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. There are a total of 7 additional InvestingPro Tips listed, which could help inform your investment decisions regarding Lisata Therapeutics.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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