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Certara, Inc. - CERT STOCK NEWS

Welcome to our dedicated page for Certara news (Ticker: CERT), a resource for investors and traders seeking the latest updates and insights on Certara stock.

Overview of Certara, Inc.

Certara, Inc. (symbol: CERT) is a global provider renowned for its biosimulation technology and advanced decision support systems that drive model-informed drug development. Utilizing scientific software and consulting services, Certara empowers biopharmaceutical companies, academic researchers, and regulatory agencies to optimize drug discovery processes and enhance patient care. The company excels in leveraging biosimulation, drug development, and model-informed development techniques to provide robust solutions that transform the way medicines are developed, assessed, and regulated.

Business Focus and Core Offerings

Certara integrates highly specialized simulation software with expert regulatory consulting and technology solutions. Its offerings are designed to streamline various stages of the drug development lifecycle, from early discovery to clinical trial design and regulatory submissions. By bridging complex scientific data and actionable insights, the company assists in reducing the reliance on extensive clinical trials, accelerates regulatory approvals, and enhances patient access to novel therapies.

Advanced Technology and Simulation Capabilities

The company is at the forefront of innovation with its comprehensive suite of software solutions. Certara's offerings include modeling and simulation platforms which incorporate advanced techniques such as quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetics (PBPK). These tools are designed to simulate human physiology and drug interactions, thereby refining dosing strategies and minimizing risk during clinical development phases. The introduction of integrated solutions, such as Certara Cloud, demonstrates the seamless connectivity of different software products, enabling customers to manage licenses, perform detailed analysis, and generate reliable insights within a unified workflow.

Regulatory Science and Consulting Services

Certara's expertise extends into regulatory science and consulting, areas that are critical for navigating the complex frameworks of drug development. By offering detailed regulatory strategies and scientific consulting, the company supports clients in meeting the rigorous requirements of global health authorities. The unique combination of advanced modeling software and regulatory insight helps clients reduce uncertainty and increase the probability of successful regulatory outcomes, offering a significant strategic advantage in the competitive pharmaceutical market.

Market Presence and Competitive Position

Operating across the Americas, EMEA, and Asia Pacific, Certara has cemented its role as a key contributor in the drug development sector. The company’s clientele includes major global biopharmaceutical companies, leading academic institutions, and influential regulatory bodies. Its technology-driven approach to accelerating drug development positions it uniquely within the competitive landscape, providing a robust alternative to traditional clinical trial methodologies and reinforcing its authority in the realm of biosimulation and regulatory strategy services.

Integrated Solutions and Client Benefits

One of the signature aspects of Certara is its integrated platform approach. Products like Certara Cloud offer a centralized portal for accessing multiple software solutions, thus streamlining workflows for users managing diverse aspects of drug development. This integration not only enhances operational efficiency but also provides a scalable and interoperable environment where feedback from users is continually incorporated into the evolution of the company's software suite. By addressing complex drug development challenges with precise and reliable modeling and simulation tools, Certara ensures that scientists and regulators can derive actionable insights more rapidly.

Scientific Expertise and Industry Application

Certara leverages its scientific expertise to address inherent challenges in drug development. The company’s simulation solutions facilitate more informed decision making, improving both the efficiency and safety of clinical trials. Its scientifically advanced models enable the transformation of raw data into strategic insights, thereby streamlining the path from research to patient care. This expertise is critical in an industry where optimizing therapeutic outcomes and meeting regulatory demands are of utmost importance.

Conclusion

In summary, Certara, Inc. stands as a sophisticated confluence of technology, scientific expertise, and regulatory insight. Its comprehensive suite of modeling, simulation, and consulting services provides a concrete foundation for revolutionizing the drug development process. By consistently delivering precise, integrated solutions and employing advanced simulation techniques, Certara plays an instrumental role in bridging the gap between innovative research and the swift, safe delivery of new medicines to patients.

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Certara, Inc. to release Q3 2023 financial results and participate in Stephens Annual Investment Conference
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Certara, Inc. successfully supports 300 completed submissions to regulatory agencies worldwide
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Certara, Inc. to participate in investor conferences
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Certara's Simcyp group has been awarded two new grants from the FDA to expand its predictive models for drug virtual bioequivalence (VBE) and create a formulation toolbox for topically applied drugs. These capabilities will enable safer, faster, and more cost-effective product development. Virtual bioequivalence (VBE) trial simulations using PBPK modeling can reduce or replace costly and time-consuming clinical trials. The grants will also support the development of a reliable dermal PBPK model for lower risk and more efficient development of generic drug products.
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Certara, a global leader in biosimulation, reported its financial results for the second quarter of fiscal year 2023. Revenue was $90.5 million, net income was $4.7 million, and adjusted EBITDA was $32.4 million. The company's software business performed well, but lower growth in services due to cautious spending led to a restatement of the 2023 outlook. Certara is updating its full year 2023 guidance with revenue expected in the range of $345 million to $360 million.
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Certara, a global leader in Biosimulation, announced that Korea Institute of Toxicology (KIT) will implement Certara’s Pinnacle 21 Enterprise and SEND Explorer software. The software optimizes data analysis and visualization for regulatory compliance and enables scientists to gain scientific insight. Pinnacle 21 Enterprise validates compliance with CDISC standards and has been adopted by FDA and PMDA. SEND Explorer provides advanced viewing and visualization capabilities for nonclinical study data.
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Certara's Leadership in Drug Approvals

On April 27, 2023, Certara, Inc. (Nasdaq: CERT) announced that its clients achieved a remarkable milestone, with 90% of new drug approvals from the FDA's CDER in 2022. This marks the ninth consecutive year of significant FDA approvals for Certara’s clients, using its innovative biosimulation software across multiple therapeutic areas, including oncology and rare diseases.

Certara's Simcyp™ and Phoenix™ software have been instrumental in informing drug label claims and evaluating drug applications, respectively. Notably, these tools aided in the approval of eight oncology drugs among other critical treatments, reflecting Certara's commitment to enhancing drug development efficiency and safety for patients worldwide.

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FAQ

What is the current stock price of Certara (CERT)?

The current stock price of Certara (CERT) is $9.55 as of April 4, 2025.

What is the market cap of Certara (CERT)?

The market cap of Certara (CERT) is approximately 1.5B.

What is the core business of Certara, Inc.?

Certara specializes in providing biosimulation software, modeling solutions, and consulting services to optimize drug development and regulatory processes. Its solutions help reduce clinical trial times and improve patient safety.

How does Certara support drug development?

Certara combines advanced simulation technologies like QSP and PBPK with regulatory consulting, enabling clients to better predict drug behavior and streamline clinical trial design. This integrated approach enhances decision-making throughout the development process.

What technology platforms are provided by Certara?

Certara offers a suite of scientific software solutions including modeling and simulation platforms and integrated solutions such as Certara Cloud. These are designed to provide a cohesive environment for managing diverse aspects of drug development.

Who are the primary clients of Certara?

Certara serves a wide range of clients including global biopharmaceutical companies, academic institutions, and regulatory agencies. These organizations rely on its advanced software solutions and consulting expertise to enhance their drug development pipelines.

How does Certara differentiate itself in the market?

Certara differentiates itself through a unique combination of sophisticated biosimulation technology and deep regulatory expertise. Its integrated platforms and scientifically robust models offer enhanced workflow efficiency and improved regulatory outcomes.

What benefits do clients gain from using Certara's platforms?

Clients benefit from streamlined drug development processes, reduced trial durations, and increased regulatory approval probabilities. The advanced simulation tools provide accurate insights that facilitate informed decision-making across the lifecycle of pharmaceutical development.
Certara, Inc.

Nasdaq:CERT

CERT Rankings

CERT Stock Data

1.53B
120.87M
2.27%
96.57%
3.34%
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