BASKING RIDGE, N.J. - Lisata Therapeutics, Inc. (NASDAQ:LSTA), a developer of treatments for advanced solid tumors, announced today that its leading drug candidate, LSTA1, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma, a rare form of bone cancer.
This designation comes on the heels of the company's recent announcement on March 21, 2024, that LSTA1 received the Rare Pediatric Disease Designation for the same condition. Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer at Lisata, expressed the company's enthusiasm for the FDA's recognition, emphasizing the urgent need for new treatments for osteosarcoma patients.
The ODD status is expected to benefit Lisata by providing seven years of marketing exclusivity post-approval, fee waivers, and tax credits for clinical testing. It may also facilitate a more efficient clinical development process through closer FDA collaboration.
LSTA1 is an investigational drug that employs a novel mechanism to enhance the delivery of anti-cancer drugs to solid tumors. It has shown promise in non-clinical data and has demonstrated safety and efficacy in clinical trials for pancreatic cancer.
The drug has previously received ODD for pancreatic cancer in the U.S. and Europe, as well as for glioblastoma multiforme in the U.S. Additionally, it has been granted Fast Track designation for pancreatic cancer treatment.
Lisata Therapeutics focuses on the discovery and commercialization of new therapies for serious diseases and has projected that its current capital will support its operations and planned clinical trials through early 2026. The company's CendR Platform® Technology underpins its research and development efforts, and it has established significant commercial partnerships.
The information in this article is based on a press release statement from Lisata Therapeutics. It should be noted that forward-looking statements involve risks and uncertainties, and actual results may differ materially. The company advises that the statements should not be seen as guarantees of future performance.
InvestingPro Insights
Lisata Therapeutics, Inc. (NASDAQ:LSTA) has recently achieved important regulatory milestones with its leading drug candidate, LSTA1. As investors evaluate the potential impact of these developments on the company's financial health and stock performance, several key metrics and insights from InvestingPro provide valuable context.
The company's market capitalization stands at a modest $24.17 million, reflecting its status as a smaller player in the biotech space. Despite the positive news regarding LSTA1, Lisata Therapeutics has been facing financial challenges, as indicated by its negative price-to-earnings (P/E) ratio of -1.16 for the last twelve months as of Q4 2023. This metric suggests that the company is not currently profitable, which aligns with the InvestingPro Tip that analysts do not anticipate the company will be profitable this year.
Additionally, the price performance of Lisata's stock has seen a large uptick over the last six months, with a 37.91% price total return, potentially indicating investor optimism following the recent designations for LSTA1. However, it's important to note that over the past year, the stock has experienced an overall decline of -5.52% in price total return.
Investors looking for deeper insights into Lisata Therapeutics can find additional InvestingPro Tips on the platform. For instance, the company holds more cash than debt on its balance sheet, which could be a sign of financial stability. On the other hand, the company is quickly burning through cash, which could raise concerns about its long-term sustainability. In total, there are 10 InvestingPro Tips available that provide a comprehensive analysis of the company's financial health and stock performance.
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