LANCASTER, Calif. - Simulations Plus , Inc. (NASDAQ:SLP), a provider of modeling and simulation software, announced the renewal of the U.S. Food and Drug Administration's (FDA) license for its DILIsym® software platform. This renewal marks a continued partnership, allowing FDA employees to utilize DILIsym in evaluating drug-induced liver injury (DILI) risks for drug approvals.
DILIsym serves as a tool for predicting DILI risk in new drug candidates and understanding the mechanisms behind liver toxicity. The software's ability to simulate safe dosing regimens contributes to the development of new therapies by informing pharmaceutical teams about efficacy and safety considerations.
The FDA's use of DILIsym reflects a growing trend in regulatory environments to incorporate advanced technologies such as quantitative systems toxicology (QST) models in their review processes. Dr. Brett A. Howell, President of Quantitative Systems Pharmacology Solutions at Simulations Plus, expressed enthusiasm for the FDA's adoption of these methodologies.
Simulations Plus has been at the forefront of the DILIsym software's development for 14 years through the DILI-sim Initiative, a public-private partnership. The platform is offered to the pharmaceutical and chemical industries, with membership in the consortium or commercial licenses available for direct use.
The company, with over 25 years of experience, provides a range of software and consulting services in the biosimulation market, supporting drug discovery, development, and regulatory submissions. Simulations Plus emphasizes its commitment to Environmental, Social, and Governance (ESG) efforts, which is detailed in its 2023 ESG update.
This announcement is based on a press release statement and contains forward-looking statements subject to risks and uncertainties. Actual future results could differ from those anticipated. Further information regarding risk factors can be found in the company's reports filed with the U.S. Securities and Exchange Commission.
InvestingPro Insights
As Simulations Plus, Inc. (NASDAQ:SLP) continues to strengthen its partnership with the FDA, InvestingPro data highlights the company's financial health and market performance. With a market capitalization of $767.93 million, Simulations Plus is a notable player in the biosimulation market. The company's commitment to innovation and safety in drug development is reflected in its financial metrics, with a robust gross profit margin of 78.73% over the last twelve months as of Q1 2024. This high margin demonstrates the company's efficiency in converting revenue into gross profit, an essential factor for investors considering the company's value proposition.
Despite the company's strong gross profit margin, it is trading at a high earnings multiple, with a P/E ratio of 74 and an adjusted P/E ratio of 52.34 for the last twelve months as of Q1 2024. This suggests that investors are willing to pay a premium for Simulations Plus shares, possibly due to the company's specialized software offerings and its strategic relationship with regulatory bodies like the FDA. Additionally, Simulations Plus has maintained dividend payments for 13 consecutive years, providing a dividend yield of 0.62% as of the latest data, which may appeal to income-focused investors.
InvestingPro Tips for Simulations Plus indicate that the management has been actively buying back shares, a sign that company leadership is confident in the firm's future prospects. Furthermore, the company holds more cash than debt on its balance sheet, providing financial stability and flexibility. For investors seeking more detailed analysis, there are 11 additional InvestingPro Tips available, offering deeper insights into Simulations Plus's financial health and market position. To access these tips and enhance your investment strategy, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at https://www.investing.com/pro/SLP.
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