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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.
Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, has announced it will release its financial results for the third quarter of 2024 after the market close on Wednesday, November 6th, 2024. The company management will host a conference call to discuss the financial results at 5:00PM ET. Investors interested in participating in the conference call are required to register online, with registration recommended at least one day in advance. A live and archived webcast of the event will be available on the "Investors" section of Certara's website at https://ir.certara.com/.
Certara, Inc. (Nasdaq: CERT), a leader in model-informed drug development, has completed the acquisition of Chemaxon, a developer of scientific informatics software for in-silico research in the life sciences industry. The combined organization aims to offer improved predictive biosimulation and scientific informatics capabilities to enhance decision-making from discovery through commercialization.
Key points:
- Integration plans include incorporating Chemaxon's chemistry structures, calculators, and predictors into Certara's D360 applications and Simcyp™ PBPK Simulator.
- Long-term plans involve leveraging Certara.AI's specialized GPT capabilities and expanding pharmacokinetics and pharmacodynamics knowledge in drug discovery processes.
- Chemaxon is expected to generate software revenue exceeding $20 million in 2024.
- Certara will update its 2024 guidance to include Chemaxon's contribution in its third-quarter earnings report in November.
Certara (Nasdaq: CERT) celebrates the 25th anniversary of its Simcyp Consortium, a pre-competitive scientific research group comprising 35 leading biopharmaceutical companies. The consortium has become a global authority on physiologically-based pharmacokinetic (PBPK) modeling and simulation.
The Simcyp Simulator, used by pharmaceutical companies, academia, and regulatory agencies, has informed dosing decisions for over 375 label claims across 115+ drugs. It accurately predicts drug behavior in the human body, aiding various stages of drug development.
The consortium has awarded grants totaling $1.4 million to support 13 PhD and postdoctoral researchers. Simcyp provides academic licenses to more than 110 universities worldwide, and its publications have been cited over 8,000 times in scientific literature.
Certara (Nasdaq: CERT) and Ichnos Glenmark Innovation (IGI) collaborated on optimizing the first-in-human dosing strategy for ISB 2001, a trispecific T-cell engager for cancer treatment. The research, published in Nature Cancer, used virtual trials to select a higher starting dose, increasing it by 50-100 fold over conventional methods. This approach, approved by the FDA and Australian HREC, aims to reduce costs, minimize ineffective dosing, and accelerate drug development.
The collaboration leveraged Certara's expertise in quantitative systems pharmacology and physiologically-based pharmacokinetics to develop a virtual clinical trial platform. This innovative method not only enhances patient safety and efficacy but also aligns with regulatory goals to reduce animal studies. The optimized dosing strategy for ISB 2001 showcases the potential of virtual patient technology in drug development, particularly for complex biologics like T-cell engagers.
Certara (Nasdaq: CERT), a leader in model-informed drug development, has announced its participation in two upcoming investor conferences. The company will be present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 at 4:05 p.m. ET and the Baird Global Healthcare Conference on September 11 at 10:15 a.m. ET.
Both conference presentations will be available via live webcasts on Certara's investor relations website at https://ir.certara.com. These webcasts will remain accessible for replay for at least 90 days after the events. This participation provides investors with opportunities to gain insights into Certara's operations and future prospects directly from the company's management.
Certara (Nasdaq: CERT) has launched Phoenix™ version 8.5, an upgraded drug development software used by top pharmaceutical companies and regulatory agencies worldwide. This release aims to improve the efficiency, quality, and speed of pharmacokinetic/pharmacodynamic (PK/PD) workflows. Key features include:
1. Sign-in via Certara Cloud for simplified license management and enhanced access control
2. Reporting enhancements for better data presentation and analysis
3. NLME improvements for more precise modeling and interpretation
Phoenix 8.5 was developed based on customer feedback to streamline drug development processes and potentially reduce the high failure rate of new medicines in clinical trials. The software is available as a hosted solution for improved performance and cost-effectiveness.
Certara (Nasdaq: CERT) reported its Q2 2024 financial results, showing mixed performance. Revenue increased 3% year-over-year to $93.3 million, driven by 13% growth in software revenue to $38.2 million. However, services revenue declined 3% to $55.1 million. The company reported a net loss of $12.6 million, compared to a net income of $4.7 million in Q2 2023. Adjusted EBITDA decreased to $26.3 million from $32.4 million last year.
Despite challenges in services due to cautious spending among large biopharma customers, Certara reiterated its full-year 2024 guidance. The company expects revenue between $385-400 million, adjusted EBITDA margin of 31-33%, and adjusted diluted EPS of $0.41-$0.46.
Certara, a leader in model-informed drug development, has signed a definitive agreement to acquire cheminformatics software provider Chemaxon. The acquisition is expected to close in the second half of 2024, pending regulatory approvals. This deal aims to enhance Certara's drug discovery capabilities by integrating Chemaxon's software, which is important for chemical structure drawing, property prediction, and analysis.
Chemaxon is projected to generate over $20 million in software revenue in 2024 and is expected to align with Certara’s EBITDA margin by the end of 2025. The combined entity will offer a comprehensive data and predictive analytics platform, expected to improve decision-making and reduce costs in drug development.
Certara has reiterated its full-year 2024 financial outlook, excluding Chemaxon, and will update its guidance post-transaction, maintaining an adjusted EBITDA margin of 31-33%.
Certara (Nasdaq: CERT), a global leader in model-informed drug development, will announce its Q2 2024 financial results after market close on August 6th, 2024. The announcement will be followed by a conference call at 5:00 PM ET to discuss the results. Investors are advised to register online for the call at least a day in advance. The event will be broadcast live and archived on Certara's investor relations website.
Certara (Nasdaq: CERT) has launched its next-generation CoAuthor regulatory writing software, enhancing the medical writing process using generative AI. Unveiled on June 17, 2024, CoAuthor integrates AI, document templates, and Microsoft Word, aiming to expedite the creation of regulatory documents while maintaining a 'human in the loop' approach. The software allows medical writers to efficiently synthesize complex biomedical data, providing a secure and specialized GPT for the drug development sector.
The platform promises to improve drafting times by at least 30%, enhancing content curation and quality control. Certara’s CEO, William Feehery, emphasized the company's expertise in maximizing AI’s potential in drug development. CoAuthor will be presented at the DIA Annual Meeting in San Diego, featuring a dedicated session on June 17th.
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