View ValuationCertara 将来の成長Future 基準チェック /46Certara利益と収益がそれぞれ年間67.5%と7.9%増加すると予測されています。EPS は年間 増加すると予想されています。自己資本利益率は 3 年後に7.2% 66.9%なると予測されています。主要情報67.5%収益成長率66.90%EPS成長率Healthcare Services 収益成長0%収益成長率7.9%将来の株主資本利益率7.16%アナリストカバレッジGood最終更新日12 May 2025今後の成長に関する最新情報お知らせ • May 12Certara, Inc. Updates Earnings Guidance for the Full Year 2026Certara, Inc. updated earnings guidance for the full year 2026. For the period, revenue is expected to be $395 million - $405 million, including Regulatory and Medical Writing revenue of approximately $18 million. Fully diluted shares are expected to be in the range of 157 million - 159 million.お知らせ • Feb 26Certara, Inc. Provides Earnings Guidance for the Full Year 2026Certara, Inc. provided earnings guidance for the full year 2026 . For the year, company revenue is expected to grow in the range of 0% to 4%.お知らせ • Nov 07Certara, Inc. Provides Earnings Guidance for the Year 2025Certara, Inc. provides earnings guidance for the year 2025. For the year, the company expects revenue to be in the range of $415 million to $420 million.お知らせ • Aug 07Certara, Inc. Reiterates Its Earnings Guidance for the Full Year 2025Certara, Inc. reiterated its earnings guidance for the full year 2025. For the full year company expects Full year 2025 revenue to be in the range of $415 million to $425 million.お知らせ • May 06Certara, Inc. Reiterates Earnings Guidance for the Full Year 2025Certara, Inc. reiterated earnings guidance for the full year 2025. Full year 2025 revenue to be in the range of $415 million to $425 million.お知らせ • Feb 27Certara, Inc. Provides Earnings Guidance for the Full Year 2025Certara, Inc. provided earnings guidance for the full year 2025. For the year, the company expects revenue to be in the range of $415 million to $425 million.すべての更新を表示Recent updatesお知らせ • May 12Certara, Inc. Updates Earnings Guidance for the Full Year 2026Certara, Inc. updated earnings guidance for the full year 2026. For the period, revenue is expected to be $395 million - $405 million, including Regulatory and Medical Writing revenue of approximately $18 million. Fully diluted shares are expected to be in the range of 157 million - 159 million.お知らせ • Apr 10Certara, Inc. to Report Q1, 2026 Results on May 11, 2026Certara, Inc. announced that they will report Q1, 2026 results Pre-Market on May 11, 2026お知らせ • Apr 06Certara, Inc., Annual General Meeting, May 14, 2026Certara, Inc., Annual General Meeting, May 14, 2026.お知らせ • Apr 02Certara, Inc. Announces Resignation of Director Cynthia Collins, Effective May 14, 2026Certara, Inc. announced that on March 27, 2026, Cynthia Collins, a member of the Board of Directors and the Audit Committee of the Board, notified the Company of her intention to resign as a Class II director on the Board, effective as of May 14, 2026, the date of the Company's 2026 annual meeting of stockholders.お知らせ • Mar 03Certara Inc Announces Simcyp Simulator Results Replace Ten Human Trials For Chronic Myeloid Leukemia Therapy AsciminibCertara, Inc. enabled physiologically-based pharmacokinetic (PBPK) modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application (NDA) for asciminib (Scemblix®). PBPK modeling uses virtual biological systems to predict how drugs are absorbed, distributed, metabolized, and eliminated by the body, and is increasingly being applied in place of certain clinical studies where appropriate. The results published in “Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib” (Loisios-Konstantinidis et al.), highlight the growing impact and business benefits of model-informed drug development approaches for regulatory decision-making. Asciminib is the first-in-class allosteric inhibitor that specifically binds the BCR::ABL1 myristoyl pocket used to treat patients with Chronic Myeloid Leukemia (CML). The global incidence rate of CML was close to one case in 100,000 population in 2018, and it accounts for approximately 15% of newly diagnosed cases of leukemia in adults. Given its potential for drug-drug interactions and the need to evaluate multiple dosing regimens, PBPK modeling with the Simcyp Simulator enabled a mechanistic assessment of asciminib’s pharmacokinetics across diverse patient populations, dosing regimens and clinical scenarios. These simulations provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA. Key results from the PBPK modeling included: Bridging between clinically tested and untested scenarios; Replacement of at least ten dedicated clinical pharmacology studies; Accurate characterization of asciminib pharmacokinetics across healthy volunteers and cancer patients; Predicting how medicines work in real-life patients taking other medications. The modeling work for asciminib evolved over a decade and contributed to richer understanding its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval and an important new treatment for patients with CML.お知らせ • Feb 26Certara, Inc. Provides Earnings Guidance for the Full Year 2026Certara, Inc. provided earnings guidance for the full year 2026 . For the year, company revenue is expected to grow in the range of 0% to 4%.お知らせ • Jan 29Certara, Inc. to Report Q4, 2025 Results on Feb 26, 2026Certara, Inc. announced that they will report Q4, 2025 results at 9:30 AM, US Eastern Standard Time on Feb 26, 2026お知らせ • Dec 11+ 1 more updateCertara, Inc. Announces CEO ChangesCertara, Inc. announced that it has appointed Jon Resnick as its next Chief Executive Officer, effective January 1, 2026, succeeding William F. Feehery, who will serve as an external advisor during a transition period. Resnick brings over 20 years of experience with IQVIA, a global technology-enabled, data and analytics and services business that helps life sciences organizations develop and commercialize therapies. Since 2019, he has served as the President of the United States and Canada regional business, with overall management responsibility for the region’s commercial business. Prior to this role and immediately following the merger of IMS Health and Quintiles, Resnick served as President of IQVIA’s Real World Solutions business. Before the merger, Resnick was the Vice President and General Manager for IMS Health’s Real-World Solutions business and had various positions in IQVIA’s US and EMEA consulting and services organization. Prior to joining IQVIA in 2002, Resnick worked for the U.S. Senate Committee on Finance, where he advised on healthcare policy and developed legislation around Medicare, Medicaid and broader healthcare reform. He holds an MBA from Northwestern University’s Kellogg School of Management and a degree in Political Science from Union College. William Feehery guided Certara through its successful IPO, led investments in software development, and reinforced Certara’s position as a global biosimulation leader.お知らせ • Nov 07Certara, Inc. Provides Earnings Guidance for the Year 2025Certara, Inc. provides earnings guidance for the year 2025. For the year, the company expects revenue to be in the range of $415 million to $420 million.お知らせ • Nov 05Certara, Inc. Announces the Launch of TFL StudioCertara, Inc. announced the launch of TFL Studio, the first cloud-native module of its Phoenix Cloud solution. TFLs (Tables, Figures, and Listings) present data on study participants, treatments, and outcomes visually for clear interpretation. They are critical components of regulatory submissions and scientific publications. TFL Studio lets pharmacokinetic (PK) and pharmacodynamic (PD) scientists create these components with greater speed and collaboration. Traditional TFL workflows are often hindered by manual processes, fragmented tools, and the challenges of maintaining visual quality and consistency across studies. Phoenix Cloud is designed to accelerate these and related PK workflows through AI and cloud technology. A complementary module, AI PK Reports, will be released this quarter. AI PK Reports leverages GenAI to turnables, figures, and listings into draft PK reports, reducing a process that typically takes scientists days to complete down to minutes. AI PK Reports are powered by CoAuthor™?, Certara's GenAI software for regulatory and medical writing. TFL Studio delivers a user-friendly, no-code environment where scientists can: Build TFLs Faster with Reusable Templates: Create, maintain, and apply standardized templates, reducing setup time and ensuring consistency. Generate Dynamic, Editable Outputs: Easily fine-tune TFLs from source data without intermediate preparation, streamlining the editing and review process. Lower Training Burden: Intuitive tools and transparent workflows make it easier for new users to quickly become proficient, fostering broader adoption across teams. As the inaugural cloud-native module of Phoenix Cloud, TFL Studio sets the stage for future innovations, including the AI PK Reports module described above. It integrates with Integral™?, Certara's data repository, providing a single source of truth for PK/PD data, models and visualizations. TFL Studio is available now as part of the Phoenix Cloud solution.お知らせ • Oct 31Certara, Inc. Expands Biosimulation Market with AI-Driven QSP PlatformCertara, Inc. announced the launch of Certara IQ, a scalable, AI-powered Quantitative Systems Pharmacology (QSP) solution. QSP has rapidly become a cornerstone of modern drug discovery and development with QSP-based FDA submissions having nearly doubled every 1.4 years since 2013.1 QSP combines computational modeling and experimental data to examine how a drug interacts with biological systems and disease processes, enabling scientists to predict critical outcomes such as optimal dosing, therapeutic window, and ideal patient populations. These capabilities are especially critical for novel or complex modalities. Certara IQ removes many of the computational and workflow challenges that have historically limited QSP adoption including minimal model reuse, long simulation times, complex coding environments, and a lack of standardization. Its AI-driven software reduces manual work and enhances reproducibility, making QSP modeling faster, easier, and more impactful. Certara IQ: Enhances model reproducibility and reusability through an intuitive, generative-AI supported interface for building and visualizing QSP models; Accelerates model creation with a deep repository of scientifically validated and pre-built QSP models, workflows and report templates; Reduces computational bottlenecks with a high-performance simulation engine that runs simulations thousands of times faster than traditional tools; Empowers decision making with a no-code interface for "what-if" analysis to assess feasibility, identify data gaps, and optimize dosing and drug properties quickly.お知らせ • Oct 10Certara, Inc. to Report Q3, 2025 Results on Nov 06, 2025Certara, Inc. announced that they will report Q3, 2025 results After-Market on Nov 06, 2025お知らせ • Sep 04Certara Launches Pinnacle 21 Enterprise Plus to Deliver Regulatory Submissions FasterCertara, Inc. announced the availability of Pinnacle 21 Enterprise Plus. The solution enables clinical and statistical programmers to efficiently create, reuse, and manage required data specifications for creating the CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets. These datasets are required when sponsors present their study safety and efficacy results and analysis to regulators. Traditional, spreadsheet-based methods of managing specifications are prone to errors, lack version control, andinder collaboration. Pinnacle 21 Enterprise Plus directly addresses these challenges by offering a unified, collaborative workspace that accelerates the journey from source data to submission-ready datasets. The no-code interface is set to deliver a 50% reduction in time spent drafting mapping specifications, according to internal measurements. Benefits of Pinnacle 21 Enterprise Plus: Support for industry and proprietary standards: Configurable columns ensure compliance with both CDISC and company-specific standards for maximum flexibility. Seamless Integration for programmers: The platform facilitates the export of mapping specifications via application programming interfaces (APIs) for seamless integration with downstream programming tools likeAS and R. Faster Submission Cycle Times: Earlier and easier creation of SDTM and ADaM mapping specifications provides submission-ready data sooner, mitigating end-of-study delays. Pinnacle 21 Enterprise Plus is purpose-built for clinical and statistical programmers, the same professionals who rely on Pinnacle 21 Foundational Enterprise for critical data validation. Most teams can go live with Pinnacle 21 in less than a month.お知らせ • Aug 07Certara, Inc. Reiterates Its Earnings Guidance for the Full Year 2025Certara, Inc. reiterated its earnings guidance for the full year 2025. For the full year company expects Full year 2025 revenue to be in the range of $415 million to $425 million.お知らせ • Aug 04Certara Simcyp Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK ModelingCertara, Inc. announced that the European Medicines Agency (EMA) has formally qualified the Simcyp®? Simulator for use in regulatory submissions across the EU. Certara is the first company to receive EMA qualification for a PBPK modeling platform, and Simcyp is the only software to hold this designation. The recognition follows a rigorous multi-year, collaborative engagement between Certara and the EMA. With this qualification in place, sponsors can now use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk without needing to re-establish the platform's credibility for the specified context of use (COU) scenarios. Simcyp has long been the leading biosimulation software used in submissions to the EU and other regulatory agencies, and this qualification makes the drug submission process easier and faster. Drug-drug interaction (DDI") studies typically involve the co-administration of two or more drugs, where one acts as a substrate and the other as a perpetrator. The qualification opinion covers various scenarios (3 COUs) where Simcyp simulations can replace clinical DDI studies using a range of verified substrates and perpetrators integrated within the platform. The COUs span 6 CYP enzymes and 2 inhibition mechanisms, thereby significantly reducing the number of clinical studies a sponsor has to conduct.お知らせ • Aug 01Certara, Inc. Appoints Christopher Bouton as Chief Technology OfficerCertara, Inc. announced the appointment of Christopher Bouton, Ph.D., as Chief Technology Officer. In this role, Bouton will lead technology strategy and development of a next-generation integrated model-informed drug development (MIDD) platform, which is enabled by generative AI and advances in biosimulation technology.Dr. Bouton was the founder and CEO of Vyasa Analytics, acquired by Certara in 2022. Vyasa provided scalable deep-learning software, which allows Certara software to make new predictions and answer complex questions across structured and unstructured data sources. Chris has led the development of several new Certara AI-based products, including CoAuthor ™, a generative AI product for regulatory and medical writing. Earlier in his career, Chris founded and led Entagen, an enterprise analytics software provider acquired by Thomson Reuters, and started his work in drug development as a computational biologist at Pfizer. Certara’s next-generation modeling platform integrates its scientific expertise, broad portfolio of solutions, and AI approaches to increase the efficiency and effectiveness of discovering and developing novel therapeutics.お知らせ • Jul 10Certara, Inc. to Report Q2, 2025 Results on Aug 06, 2025Certara, Inc. announced that they will report Q2, 2025 results After-Market on Aug 06, 2025お知らせ • May 06Certara, Inc. Reiterates Earnings Guidance for the Full Year 2025Certara, Inc. reiterated earnings guidance for the full year 2025. Full year 2025 revenue to be in the range of $415 million to $425 million.お知らせ • Apr 14+ 1 more updateCertara Launches Non- Animal Navigator™? Solution to Help Drug Developers Reduce Reliance on Animal TestingCertara, Inc. announced the launch of its Non- Animal Navigator™? solution designed to help biopharmaceutical companies lead the transition ignited by the FDA's Roadmap to Reducing Animal Testing in Preclinical Safety Studies. The Roadmap marks a pivotal moment in drug development. Companies that act now can future-proof their portfolios, gaining competitive advantage through faster timelines, lower costs, and stronger predictive evidence. Globally, there are thousands of monoclonal antibodies and antibody-drug conjugates (ADCs) currently in the preclinical phase of development across a broad range of therapeutic areas. Monoclonal antibodies are a key area in efforts to reduce animal testing, as biosimulation models often predict human outcomes as well as or better than, traditional animal studies. For over two decades, Certara has partnered with biopharmaceutical sponsors and regulatory agencies to integrate predictive, mechanistic models into the development and regulatory evaluation of biologics, including monoclonal antibodies. Based on Certara's extensive experience working with FDA, EMA, and other major health authorities, the Non- Animal Navigator is a flexible solution that ensures each client's development program is compliant, agile, and future ready. It offers clients: Strategic Regulatory Advice - Design preclinical programs that future-proof your INDs and include the appropriate use of NAMs while ensuring regulatory alignment. Integrated Preclinical Development Plan - Build an integrated, weight-of- evidence strategy combining in vitro, in vivo, real-world evidence, and biosimulation data with expert toxicology input. Optimized AI Enabled Modeling Toolkit - Accelerate timelines with access to the most widely adopted platform for PBPK modeling, the Simcyp Simulator®?, and ready-to-use mAb Quantitative Systems Pharmacology models.お知らせ • Apr 10Certara, Inc., Annual General Meeting, May 21, 2025Certara, Inc., Annual General Meeting, May 21, 2025.お知らせ • Apr 02Certara Expands the Simcyp™ Simulator Platform Advancing Biopharmaceutics, Drug-Drug Interaction & Biologic CapabilitiesCertara, Inc. has released a new version of the Simcyp Simulator for physiologically-based pharmacokinetic (PBPK) modeling. Simcyp PBPK models describe and predict the behavior of drugs in different body tissues. The latest version includes numerous advancements to further support data-driven decision-making at every stage of development. A consortium of more than 30 leading pharmaceutical companies guides the development of the Simcyp Simulator. Version 24 incorporates their feedback, which enhances and expands existing capabilities and databases. Simcyp Simulator V24 features numerous updates, including: Biopharmaceutical capabilities and the Virtual Bioequivalence (VBE) module now include features for predicting food effects that improve the simulation of drug absorption under various meal conditions. Expanded library for drug-drug interactions (DDI): New and upgraded compound files for enzymes and transporters cover a broader range of DDI capabilities. These capabilities provide qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney. More precise characterization of the behavior of membrane-bound targets across various tissues and plasma in biologics models. These include soluble target movement and drug-target complex dynamics throughout the body, and refinements to the target shedding model. Further, nonlinear protein and plasma binding, and target-mediated drug disposition are incorporated for small molecules. Expanded Trial Design support: Enhanced speed and ease of use for designing and simulating clinical trials. Special Populations modeling: Enhanced and expanded capabilities for pediatric, pregnancy, and lactation populations. Performance and Usability: Modernized UI, cloud computing add-on, 'Ask Simcyp' AI-enabled help chat, and chemical structure-based parameter predictors. Routes of Administration: Improved functionality for long-acting injectables, inhalation, and ocular routes.お知らせ • Mar 08Certara, Inc. Announces Step Down of Patrick F. Smith as President, Certara Drug Development SolutionsOn March 5, 2025, Certara, Inc. announced that Dr. Patrick F. Smith, President, Certara Drug Development Solutions, stepped down from that role as of March 3, 2025, but will remain employed by the Company in a senior advisory and scientific role.お知らせ • Mar 06Certara, Inc. Appoints Adrian Mckemey as President of Drug Development SolutionsCertara, Inc. announced the appointment of Adrian McKemey, Ph.D. as President of Drug Development Solutions, effective March 3, 2025. In this role, McKemey will lead Certara's global team of drug development scientists. Adrian joins Certara after serving as head of Enterprise Transformation at IQVIA and Senior Vice President and Head of the R&D Strategy Solutions at Quintiles. He has over 25 years of experience in research and development roles where he focused on business transformation, portfolio management and R&D strategies. Before IQVIA, he was a Principal with the Boston Consulting Group (BCG) working in the Life Sciences practice in New York. He holds a BSc (First Class) and a PhD in High Energy Nuclear Particle Physics from the University of London. The change is part of a planned leadership transition. Patrick Smith, PharmD. will continue to support Certara’s growth in science and innovation as Senior Vice President of Translational Sciences. Patrick and his leadership team successfully led and integrated the Certara services team building a unified offering of comprehensive scientific services for life sciences clients across the globe.お知らせ • Feb 27Certara, Inc. Provides Earnings Guidance for the Full Year 2025Certara, Inc. provided earnings guidance for the full year 2025. For the year, the company expects revenue to be in the range of $415 million to $425 million.お知らせ • Jan 30Certara, Inc. to Report Q4, 2024 Results on Feb 26, 2025Certara, Inc. announced that they will report Q4, 2024 results After-Market on Feb 26, 2025お知らせ • Jan 16Certara, Inc. Provides Preliminary Financial Guidance for the Fourth Quarter and Full Year Ended December 31, 2024Certara, Inc. provided preliminary financial guidance for the fourth quarter and full year ended December 31, 2024. Preliminary financials for the fourth quarter of 2024 are expected to be: revenue of $99.7 million, compared to $88.0 million in the fourth quarter of 2023, representing growth of 13%. Preliminary financials for the full year of 2024 are expected to be: Revenue of $384.4 million, compared to $354.3 million in 2023, representing growth of 8%.お知らせ • Nov 07Certara, Inc. Updates Earnings Guidance for the Year 2024Certara, Inc. updated earnings guidance for the year 2024. For the year, revenue to be in the range of $380 million to $385 million.お知らせ • Oct 17Certara, Inc. Appoints John Reynders as Independent Board MemberCertara, Inc. announced the appointment of John Reynders, PhD, to its Board of Directors, effective October 15, 2024. Dr. Reynders has over 25 years of experience in the pharmaceutical and tech industries. He was the founding CIO of Moderna where he led the data-sciences capabilities to design mRNA therapies. Most recently, he was Chief Data Sciences Officer at Neumora, a biotech focused on brain diseases. Before that, he held various executive positions leading data-sciences, informatics, and technology organizations at Alexion Pharmaceuticals, AstraZeneca, Johnson & Johnson, Eli Lilly, and Celera.お知らせ • Oct 10Certara, Inc. to Report Q3, 2024 Results on Nov 06, 2024Certara, Inc. announced that they will report Q3, 2024 results After-Market on Nov 06, 2024お知らせ • Oct 04Certara, Inc. (NasdaqGS:CERT) completed the acquisition of ChemAxon Kft.Certara, Inc. (NasdaqGS:CERT) signed a definitive agreement to acquire ChemAxon Kft. on July 9, 2024. The transaction is subject to approval by regulatory and other customary closing conditions. The transaction is expected to close in the second half of 2024. Certara, Inc. (NasdaqGS:CERT) completed the acquisition of ChemAxon Kft. on October 2, 2024.お知らせ • Aug 16Certara, Inc. Launches Phoenix™ Version 8.5 Drug Development SoftwareCertara, Inc. announced the launch of Phoenix™ version 8.5. Phoenix is the pharmaceutical industry's gold standard in pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic modeling and simulation software. The Phoenix Platform is used by more than 75 of the top 100 pharmaceutical companies worldwide. Eleven regulatory agencies, including the U.S. FDA, Japan PMDA, and China NMPA, rely on Phoenix to evaluate life-saving drug candidates. Version 8.5 is the latest release from Certara’s Phoenix Platform, available as a hosted solution for maximum performance and lower total cost of ownership. Today, 88% of new medicines that enter clinical trials fail, indicating a need for improved processes. Certara’s Phoenix platform expedites everything from data preparation to report generation – a time-consuming process that drug developers rely on. Version 8.5 delivers new features driven by customer demand. These features improve the efficiency, quality, and speed of PK/PD workflows within Phoenix. Sign-in via Certara Cloud - Phoenix 8.5 introduces user sign-in via Certara Central Admin, offering Single Sign-On and centralized authentication. This simplifies license management, streamlines assignments, enhances access control, and improves the user experience by providing easier access to resources, training and support. Reporting Enhancements for Tables, Plotting, Reporting: Updates are designed to offer increased customization and efficiency in data presentation in tables and plots, along with advancing capabilities for visual data analysis. These improvements aim to streamline the reporting process and enable more detailed and readily interpretable reports. NLME (Non-linear mixed effects) Enhancements: Phoenix NLME is a population modeling and simulation software solution for scientists with varying levels of experience—from novice PK/PD scientists to the most advanced modelers. The 8.5 update improves the precision of modeling, increases the adaptability for users, and provides tools to enhance the interpretability of models.お知らせ • Aug 07Certara, Inc. Reiterates Earnings Guidance for the Year 2024Certara, Inc. reiterated earnings guidance for the year 2024. For the year, the company expects full year 2024 revenue to be in the range of $385 million to $400 million.お知らせ • Jul 10Certara, Inc. (NasdaqGS:CERT)signed a definitive agreement to acquire ChemAxon Kft.Certara, Inc. (NasdaqGS:CERT)signed a definitive agreement to acquire ChemAxon Kft. on July 9, 2024. The transaction is subject to approval by regulatory and other customary closing conditions. The transaction is expected to close in the second half of 2024.お知らせ • Jul 04Certara, Inc. to Report Q2, 2024 Results on Aug 06, 2024Certara, Inc. announced that they will report Q2, 2024 results After-Market on Aug 06, 2024お知らせ • Jun 18Certara Launches Next Generation CoAuthor™ Generative AI Regulatory Writing SoftwareCertara, Inc. unveiled its next-generation CoAuthor regulatory writing software. CoAuthor is an advanced writing platform designed for medical writers. It combines generative AI, document templates, Microsoft Word integration, and structured content authoring tools. CoAuthor accelerates the creation of regulatory documents while maintaining a “human in the loop” approach to the use of generative AI. Medical writing is a critical part of drug development. It relies on manual processes which have not changed significantly over the past two decades. Drug development pipelines increasingly comprise precision medicine therapies that depend on advanced biomedical knowledge. Today’s medical writers must translate complex study designs and data into documents that contextualize research results for different audiences. They need better ways to synthesize numerous sources of knowledge and securely connect them to their data and documents. Built by writers, for writers, CoAuthor is easy to use and combines a life science specialized, secure, client-specific GPT with structured content authoring and comprehensive eCTD regulatory writing templates. With CoAuthor, medical writers can streamline the document drafting process, allowing more time for content curation, collaboration, and quality control. Fully integrated with Microsoft Word, CoAuthor enables writing teams to use familiar tools, systems, and processes while ensuring consistency and quality. Certara clients will have the flexibility to work with CoAuthor as part of a comprehensive regulatory writing solution, at the program level and across the enterprise.お知らせ • May 22Certara, Inc Appoints Rona Anhalt as Chief Human Resources Officer and Daniel Corcoran as General CounselCertara, Inc. has appointed Rona Anhalt as Chief Human Resources Officer and Daniel Corcoran as General Counsel. Ms. Anhalt will drive Certara’s human capital management strategy. She will lead the company’s global Human Resources function supporting Certara’s 1,400 team members including more than 400 scientists across the globe. She has over 20 years of experience supporting strategic growth and building high-performing teams in life sciences. In her prior role at EQRx, Ms. Anhalt led HR from start-up through acquisition and championed a mission-oriented culture. Daniel Corcoran will oversee Certara’s legal affairs. He has over 20 years of experience in publicly traded and privately held global technology companies. Previously, he was the Senior Vice President of Legal and General Counsel at Nexthink where he led legal and compliance teams and helped the company prepare for its IPO.お知らせ • May 09Certara, Inc. Reiterates Earnings Guidance for the Year 2024Certara, Inc. reiterated earnings guidance for the year 2024. For the year, the company expects revenue to be in the range of $385 million to $400 million.お知らせ • Apr 16Certara, Inc. Launches Cloud Platform to Further Unify Its End-To-End Scientific Software PlatformCertara, Inc. announced the launch of Certara Cloud, the unifying platform that integrates its many scientific software solutions. Customers log into Certara Cloud using a single ID to access and manage their licensed software, linking predictive solutions to modeling and analysis of clinical trial results. Certara Cloud delivers value and unique capabilities across several areas of immediate benefit and lays the foundation for future advanced operations, including: Real-time collaboration across internal teams and external partners with reduced friction in deployment, licensing, and technical implementation. Centralized security and IT administration, leveraging Single Sign On and cross-product user management and auditing functions. Best practices documentation and media-rich educational resources from thought leaders spanning all stages of drug development including complimentary access to the gold standard PK/PD e-book, Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications. Cross-functional insights and benchmarks for clients, derived from following their drug candidate across its various stops in the Certara ecosystem. Certara Cloud is following a phased roll-out over 2024 with over 1,500 client-specific portals already prepared and is currently in use by fifteen of the top 30 biopharmaceutical companies.お知らせ • Apr 11Certara, Inc., Annual General Meeting, May 21, 2024Certara, Inc., Annual General Meeting, May 21, 2024, at 09:00 US Eastern Standard Time. Agenda: To consider election of Class I directors; to approve two separate proposals to amend our Amended and Restated Certificate of Incorporation ; to Amend our Certificate of Incorporation to limit the liability of certain officers of Certara as permitted pursuant to the Delaware General Corporation Law; to Amend our Certificate of Incorporation to make certain technical changes, including to remove inoperative provisions related to our former majority stockholder and other immaterial changes; to Ratification of the appointment of independent registered public accounting firm for the fiscal year ending December 31, 2024; and to conduct a non-binding advisory vote to approve the compensation of our named executive officers.お知らせ • Apr 10Certara, Inc. to Report Q1, 2024 Results on May 07, 2024Certara, Inc. announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 07, 2024お知らせ • Mar 01Certara, Inc. Provides Earnings Guidance for the Year 2024Certara, Inc. provided earnings guidance for the year 2024. For the year, the company expects revenue to be in the range of $385 million to $400 million.お知らせ • Feb 02Certara, Inc. to Report Q4, 2023 Results on Feb 29, 2024Certara, Inc. announced that they will report Q4, 2023 results After-Market on Feb 29, 2024お知らせ • Dec 14Certara, Inc. (NasdaqGS : CERT) acquired Applied BioMath, LLC.Certara, Inc. (NasdaqGS : CERT) acquired Applied BioMath, LLC on December 13, 2023.Certara, Inc. (NasdaqGS : CERT) completed the acquisition of Applied BioMath, LLC on December 13, 2023.お知らせ • Nov 22Certara, Inc. Announces the Introduction of Simcyp Biopharmaceutics SoftwareCertara, Inc. announced the introduction of Simcyp™? Biopharmaceutics software. It is designed for use by biopharmaceutic, formulation, and CMC scientists to aid in formulating complex novel and generic small molecule medicines quickly and cost effectively. Simcyp Biopharmaceutics software is part of the Simcyp Simulator biosimulation platform, which has supported label claims for more than 100 approved novel therapies. Simcyp Biopharmaceutics software also helps sponsors develop the evidence needed to attain biowaivers which are used in lieu of conducting clinical studies. It is available as a standalone product and is designed for life sciences companies of all sizes looking to optimize their therapies’ formulations to maximize safety, efficacy, and patient convenience. Simcyp Biopharmaceutics software delivers value and unique capabilities across several areas that are critical to achieving formulation success, including: Replace Costly Clinical Bioequivalence Studies - With growing encouragement from regulators, virtual bioequivalence studies (VBE) leverages physiologically based pharmacokinetic (PBPK) modeling to demonstrate bioequivalence (BE) between test and reference drugs. Simcyp Biopharmaceutics software includes a VBE module that automates elements of trial design significantly enhancing opportunities for attaining biowaivers. Optimize Formulation for Complex Drugs: Biopharmaceutical Classification System (BCS) Class II-IV drugs are challenging to create oral formulations for because of their poor solubility and/or absorption. Simcyp Biopharmaceutics software facilitates developing these drugs, which constitute 90% of new drug candidates. Inform Drug Labels - Recent FDA guidance recognizes physiologically-based pharmacokinetic (PBPK) models as a valuable technology for identifying and optimizing the impact of gastrointestinal effects such as meal type and pH. Simcyp Biopharmaceutics software advances these capabilities for optimizing dosing strategies and providing label guidance to clinicians.お知らせ • Nov 10Certara, Inc. Provides Revenue Guidance for the Year 2023Certara, Inc. provided revenue guidance for the year 2023. For the year, the company expects revenue to be in the range of $345 million to $360 million.お知らせ • Oct 12Certara, Inc. to Report Q3, 2023 Results on Nov 08, 2023Certara, Inc. announced that they will report Q3, 2023 results After-Market on Nov 08, 2023お知らせ • Aug 10Certara, Inc. Updates Earnings Guidance for the Year 2023Certara, Inc. updated earnings guidance for the year 2023. The company is updating its previously reported guidance for full year 2023. The company expects full year 2023 revenue to be in the range of $345 million to $360 million.お知らせ • Jul 14Certara, Inc. to Report Q2, 2023 Results on Aug 09, 2023Certara, Inc. announced that they will report Q2, 2023 results After-Market on Aug 09, 2023お知らせ • May 09Certara, Inc. Provides Revenue Guidance for the Year 2023Certara, Inc. provided revenue guidance for the year 2023. For the full year 2023, the company expects revenue to be in the range of $370 million to $385 million.お知らせ • Feb 02Certara, Inc. to Report Q4, 2022 Results on Mar 01, 2023Certara, Inc. announced that they will report Q4, 2022 results After-Market on Mar 01, 2023Breakeven Date Change • Jan 31Forecast breakeven date pushed back to 2023The 8 analysts covering Certara previously expected the company to break even in 2022. New consensus forecast suggests the company will make a profit of US$21.3m in 2023. Average annual earnings growth of 59% is required to achieve expected profit on schedule.業績と収益の成長予測BMV:CERT * - アナリストの将来予測と過去の財務データ ( )USD Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数12/31/20275021N/AN/A412/31/20264588N/AN/A1012/31/2025421-1N/AN/A103/31/2025394-37094N/A12/31/2024385-125980N/A9/30/2024373-313554N/A6/30/2024364-795169N/A3/31/2024361-616177N/A12/31/2023354-556783N/A9/30/2023353-348195N/A6/30/2023352197487N/A3/31/2023344148093N/A12/31/2022336158093N/A9/30/2022324-46678N/A6/30/2022314-106374N/A3/31/2022301-125565N/A12/31/2021286-135160N/A9/30/2021275-584452N/A6/30/2021262-554048N/A3/31/2021253-493441N/A12/31/2020244-493745N/A9/30/2020233-14554N/A6/30/202022613141N/A3/31/2020215-53040N/A12/31/2019209-92938N/A12/31/2018164-33N/A12N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: CERT *は今後 3 年間で収益性が向上すると予測されており、これは 貯蓄率 ( 8.4% ) よりも高い成長率であると考えられます。収益対市場: CERT *今後 3 年間で収益性が向上すると予想されており、これは市場平均を上回る成長と考えられます。高成長収益: CERT *今後 3 年以内に収益を上げることが予想されます。収益対市場: CERT *の収益 ( 7.9% ) MX市場 ( 6.2% ) よりも速いペースで成長すると予測されています。高い収益成長: CERT *の収益 ( 7.9% ) 20%よりも低い成長が予測されています。一株当たり利益成長率予想将来の株主資本利益率将来のROE: CERT *の 自己資本利益率 は、3年後には低くなると予測されています ( 7.2 %)。成長企業の発掘7D1Y7D1Y7D1YHealthcare 業界の高成長企業。View Past Performance企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2025/05/26 06:33終値2025/02/26 00:00収益2025/03/31年間収益2024/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Certara, Inc. 10 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。18 アナリスト機関Joseph VruwinkBairdLuke SergottBarclaysSean DodgeBMO Capital Markets Equity Research15 その他のアナリストを表示
お知らせ • May 12Certara, Inc. Updates Earnings Guidance for the Full Year 2026Certara, Inc. updated earnings guidance for the full year 2026. For the period, revenue is expected to be $395 million - $405 million, including Regulatory and Medical Writing revenue of approximately $18 million. Fully diluted shares are expected to be in the range of 157 million - 159 million.
お知らせ • Feb 26Certara, Inc. Provides Earnings Guidance for the Full Year 2026Certara, Inc. provided earnings guidance for the full year 2026 . For the year, company revenue is expected to grow in the range of 0% to 4%.
お知らせ • Nov 07Certara, Inc. Provides Earnings Guidance for the Year 2025Certara, Inc. provides earnings guidance for the year 2025. For the year, the company expects revenue to be in the range of $415 million to $420 million.
お知らせ • Aug 07Certara, Inc. Reiterates Its Earnings Guidance for the Full Year 2025Certara, Inc. reiterated its earnings guidance for the full year 2025. For the full year company expects Full year 2025 revenue to be in the range of $415 million to $425 million.
お知らせ • May 06Certara, Inc. Reiterates Earnings Guidance for the Full Year 2025Certara, Inc. reiterated earnings guidance for the full year 2025. Full year 2025 revenue to be in the range of $415 million to $425 million.
お知らせ • Feb 27Certara, Inc. Provides Earnings Guidance for the Full Year 2025Certara, Inc. provided earnings guidance for the full year 2025. For the year, the company expects revenue to be in the range of $415 million to $425 million.
お知らせ • May 12Certara, Inc. Updates Earnings Guidance for the Full Year 2026Certara, Inc. updated earnings guidance for the full year 2026. For the period, revenue is expected to be $395 million - $405 million, including Regulatory and Medical Writing revenue of approximately $18 million. Fully diluted shares are expected to be in the range of 157 million - 159 million.
お知らせ • Apr 10Certara, Inc. to Report Q1, 2026 Results on May 11, 2026Certara, Inc. announced that they will report Q1, 2026 results Pre-Market on May 11, 2026
お知らせ • Apr 06Certara, Inc., Annual General Meeting, May 14, 2026Certara, Inc., Annual General Meeting, May 14, 2026.
お知らせ • Apr 02Certara, Inc. Announces Resignation of Director Cynthia Collins, Effective May 14, 2026Certara, Inc. announced that on March 27, 2026, Cynthia Collins, a member of the Board of Directors and the Audit Committee of the Board, notified the Company of her intention to resign as a Class II director on the Board, effective as of May 14, 2026, the date of the Company's 2026 annual meeting of stockholders.
お知らせ • Mar 03Certara Inc Announces Simcyp Simulator Results Replace Ten Human Trials For Chronic Myeloid Leukemia Therapy AsciminibCertara, Inc. enabled physiologically-based pharmacokinetic (PBPK) modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application (NDA) for asciminib (Scemblix®). PBPK modeling uses virtual biological systems to predict how drugs are absorbed, distributed, metabolized, and eliminated by the body, and is increasingly being applied in place of certain clinical studies where appropriate. The results published in “Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib” (Loisios-Konstantinidis et al.), highlight the growing impact and business benefits of model-informed drug development approaches for regulatory decision-making. Asciminib is the first-in-class allosteric inhibitor that specifically binds the BCR::ABL1 myristoyl pocket used to treat patients with Chronic Myeloid Leukemia (CML). The global incidence rate of CML was close to one case in 100,000 population in 2018, and it accounts for approximately 15% of newly diagnosed cases of leukemia in adults. Given its potential for drug-drug interactions and the need to evaluate multiple dosing regimens, PBPK modeling with the Simcyp Simulator enabled a mechanistic assessment of asciminib’s pharmacokinetics across diverse patient populations, dosing regimens and clinical scenarios. These simulations provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA. Key results from the PBPK modeling included: Bridging between clinically tested and untested scenarios; Replacement of at least ten dedicated clinical pharmacology studies; Accurate characterization of asciminib pharmacokinetics across healthy volunteers and cancer patients; Predicting how medicines work in real-life patients taking other medications. The modeling work for asciminib evolved over a decade and contributed to richer understanding its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval and an important new treatment for patients with CML.
お知らせ • Feb 26Certara, Inc. Provides Earnings Guidance for the Full Year 2026Certara, Inc. provided earnings guidance for the full year 2026 . For the year, company revenue is expected to grow in the range of 0% to 4%.
お知らせ • Jan 29Certara, Inc. to Report Q4, 2025 Results on Feb 26, 2026Certara, Inc. announced that they will report Q4, 2025 results at 9:30 AM, US Eastern Standard Time on Feb 26, 2026
お知らせ • Dec 11+ 1 more updateCertara, Inc. Announces CEO ChangesCertara, Inc. announced that it has appointed Jon Resnick as its next Chief Executive Officer, effective January 1, 2026, succeeding William F. Feehery, who will serve as an external advisor during a transition period. Resnick brings over 20 years of experience with IQVIA, a global technology-enabled, data and analytics and services business that helps life sciences organizations develop and commercialize therapies. Since 2019, he has served as the President of the United States and Canada regional business, with overall management responsibility for the region’s commercial business. Prior to this role and immediately following the merger of IMS Health and Quintiles, Resnick served as President of IQVIA’s Real World Solutions business. Before the merger, Resnick was the Vice President and General Manager for IMS Health’s Real-World Solutions business and had various positions in IQVIA’s US and EMEA consulting and services organization. Prior to joining IQVIA in 2002, Resnick worked for the U.S. Senate Committee on Finance, where he advised on healthcare policy and developed legislation around Medicare, Medicaid and broader healthcare reform. He holds an MBA from Northwestern University’s Kellogg School of Management and a degree in Political Science from Union College. William Feehery guided Certara through its successful IPO, led investments in software development, and reinforced Certara’s position as a global biosimulation leader.
お知らせ • Nov 07Certara, Inc. Provides Earnings Guidance for the Year 2025Certara, Inc. provides earnings guidance for the year 2025. For the year, the company expects revenue to be in the range of $415 million to $420 million.
お知らせ • Nov 05Certara, Inc. Announces the Launch of TFL StudioCertara, Inc. announced the launch of TFL Studio, the first cloud-native module of its Phoenix Cloud solution. TFLs (Tables, Figures, and Listings) present data on study participants, treatments, and outcomes visually for clear interpretation. They are critical components of regulatory submissions and scientific publications. TFL Studio lets pharmacokinetic (PK) and pharmacodynamic (PD) scientists create these components with greater speed and collaboration. Traditional TFL workflows are often hindered by manual processes, fragmented tools, and the challenges of maintaining visual quality and consistency across studies. Phoenix Cloud is designed to accelerate these and related PK workflows through AI and cloud technology. A complementary module, AI PK Reports, will be released this quarter. AI PK Reports leverages GenAI to turnables, figures, and listings into draft PK reports, reducing a process that typically takes scientists days to complete down to minutes. AI PK Reports are powered by CoAuthor™?, Certara's GenAI software for regulatory and medical writing. TFL Studio delivers a user-friendly, no-code environment where scientists can: Build TFLs Faster with Reusable Templates: Create, maintain, and apply standardized templates, reducing setup time and ensuring consistency. Generate Dynamic, Editable Outputs: Easily fine-tune TFLs from source data without intermediate preparation, streamlining the editing and review process. Lower Training Burden: Intuitive tools and transparent workflows make it easier for new users to quickly become proficient, fostering broader adoption across teams. As the inaugural cloud-native module of Phoenix Cloud, TFL Studio sets the stage for future innovations, including the AI PK Reports module described above. It integrates with Integral™?, Certara's data repository, providing a single source of truth for PK/PD data, models and visualizations. TFL Studio is available now as part of the Phoenix Cloud solution.
お知らせ • Oct 31Certara, Inc. Expands Biosimulation Market with AI-Driven QSP PlatformCertara, Inc. announced the launch of Certara IQ, a scalable, AI-powered Quantitative Systems Pharmacology (QSP) solution. QSP has rapidly become a cornerstone of modern drug discovery and development with QSP-based FDA submissions having nearly doubled every 1.4 years since 2013.1 QSP combines computational modeling and experimental data to examine how a drug interacts with biological systems and disease processes, enabling scientists to predict critical outcomes such as optimal dosing, therapeutic window, and ideal patient populations. These capabilities are especially critical for novel or complex modalities. Certara IQ removes many of the computational and workflow challenges that have historically limited QSP adoption including minimal model reuse, long simulation times, complex coding environments, and a lack of standardization. Its AI-driven software reduces manual work and enhances reproducibility, making QSP modeling faster, easier, and more impactful. Certara IQ: Enhances model reproducibility and reusability through an intuitive, generative-AI supported interface for building and visualizing QSP models; Accelerates model creation with a deep repository of scientifically validated and pre-built QSP models, workflows and report templates; Reduces computational bottlenecks with a high-performance simulation engine that runs simulations thousands of times faster than traditional tools; Empowers decision making with a no-code interface for "what-if" analysis to assess feasibility, identify data gaps, and optimize dosing and drug properties quickly.
お知らせ • Oct 10Certara, Inc. to Report Q3, 2025 Results on Nov 06, 2025Certara, Inc. announced that they will report Q3, 2025 results After-Market on Nov 06, 2025
お知らせ • Sep 04Certara Launches Pinnacle 21 Enterprise Plus to Deliver Regulatory Submissions FasterCertara, Inc. announced the availability of Pinnacle 21 Enterprise Plus. The solution enables clinical and statistical programmers to efficiently create, reuse, and manage required data specifications for creating the CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets. These datasets are required when sponsors present their study safety and efficacy results and analysis to regulators. Traditional, spreadsheet-based methods of managing specifications are prone to errors, lack version control, andinder collaboration. Pinnacle 21 Enterprise Plus directly addresses these challenges by offering a unified, collaborative workspace that accelerates the journey from source data to submission-ready datasets. The no-code interface is set to deliver a 50% reduction in time spent drafting mapping specifications, according to internal measurements. Benefits of Pinnacle 21 Enterprise Plus: Support for industry and proprietary standards: Configurable columns ensure compliance with both CDISC and company-specific standards for maximum flexibility. Seamless Integration for programmers: The platform facilitates the export of mapping specifications via application programming interfaces (APIs) for seamless integration with downstream programming tools likeAS and R. Faster Submission Cycle Times: Earlier and easier creation of SDTM and ADaM mapping specifications provides submission-ready data sooner, mitigating end-of-study delays. Pinnacle 21 Enterprise Plus is purpose-built for clinical and statistical programmers, the same professionals who rely on Pinnacle 21 Foundational Enterprise for critical data validation. Most teams can go live with Pinnacle 21 in less than a month.
お知らせ • Aug 07Certara, Inc. Reiterates Its Earnings Guidance for the Full Year 2025Certara, Inc. reiterated its earnings guidance for the full year 2025. For the full year company expects Full year 2025 revenue to be in the range of $415 million to $425 million.
お知らせ • Aug 04Certara Simcyp Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK ModelingCertara, Inc. announced that the European Medicines Agency (EMA) has formally qualified the Simcyp®? Simulator for use in regulatory submissions across the EU. Certara is the first company to receive EMA qualification for a PBPK modeling platform, and Simcyp is the only software to hold this designation. The recognition follows a rigorous multi-year, collaborative engagement between Certara and the EMA. With this qualification in place, sponsors can now use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk without needing to re-establish the platform's credibility for the specified context of use (COU) scenarios. Simcyp has long been the leading biosimulation software used in submissions to the EU and other regulatory agencies, and this qualification makes the drug submission process easier and faster. Drug-drug interaction (DDI") studies typically involve the co-administration of two or more drugs, where one acts as a substrate and the other as a perpetrator. The qualification opinion covers various scenarios (3 COUs) where Simcyp simulations can replace clinical DDI studies using a range of verified substrates and perpetrators integrated within the platform. The COUs span 6 CYP enzymes and 2 inhibition mechanisms, thereby significantly reducing the number of clinical studies a sponsor has to conduct.
お知らせ • Aug 01Certara, Inc. Appoints Christopher Bouton as Chief Technology OfficerCertara, Inc. announced the appointment of Christopher Bouton, Ph.D., as Chief Technology Officer. In this role, Bouton will lead technology strategy and development of a next-generation integrated model-informed drug development (MIDD) platform, which is enabled by generative AI and advances in biosimulation technology.Dr. Bouton was the founder and CEO of Vyasa Analytics, acquired by Certara in 2022. Vyasa provided scalable deep-learning software, which allows Certara software to make new predictions and answer complex questions across structured and unstructured data sources. Chris has led the development of several new Certara AI-based products, including CoAuthor ™, a generative AI product for regulatory and medical writing. Earlier in his career, Chris founded and led Entagen, an enterprise analytics software provider acquired by Thomson Reuters, and started his work in drug development as a computational biologist at Pfizer. Certara’s next-generation modeling platform integrates its scientific expertise, broad portfolio of solutions, and AI approaches to increase the efficiency and effectiveness of discovering and developing novel therapeutics.
お知らせ • Jul 10Certara, Inc. to Report Q2, 2025 Results on Aug 06, 2025Certara, Inc. announced that they will report Q2, 2025 results After-Market on Aug 06, 2025
お知らせ • May 06Certara, Inc. Reiterates Earnings Guidance for the Full Year 2025Certara, Inc. reiterated earnings guidance for the full year 2025. Full year 2025 revenue to be in the range of $415 million to $425 million.
お知らせ • Apr 14+ 1 more updateCertara Launches Non- Animal Navigator™? Solution to Help Drug Developers Reduce Reliance on Animal TestingCertara, Inc. announced the launch of its Non- Animal Navigator™? solution designed to help biopharmaceutical companies lead the transition ignited by the FDA's Roadmap to Reducing Animal Testing in Preclinical Safety Studies. The Roadmap marks a pivotal moment in drug development. Companies that act now can future-proof their portfolios, gaining competitive advantage through faster timelines, lower costs, and stronger predictive evidence. Globally, there are thousands of monoclonal antibodies and antibody-drug conjugates (ADCs) currently in the preclinical phase of development across a broad range of therapeutic areas. Monoclonal antibodies are a key area in efforts to reduce animal testing, as biosimulation models often predict human outcomes as well as or better than, traditional animal studies. For over two decades, Certara has partnered with biopharmaceutical sponsors and regulatory agencies to integrate predictive, mechanistic models into the development and regulatory evaluation of biologics, including monoclonal antibodies. Based on Certara's extensive experience working with FDA, EMA, and other major health authorities, the Non- Animal Navigator is a flexible solution that ensures each client's development program is compliant, agile, and future ready. It offers clients: Strategic Regulatory Advice - Design preclinical programs that future-proof your INDs and include the appropriate use of NAMs while ensuring regulatory alignment. Integrated Preclinical Development Plan - Build an integrated, weight-of- evidence strategy combining in vitro, in vivo, real-world evidence, and biosimulation data with expert toxicology input. Optimized AI Enabled Modeling Toolkit - Accelerate timelines with access to the most widely adopted platform for PBPK modeling, the Simcyp Simulator®?, and ready-to-use mAb Quantitative Systems Pharmacology models.
お知らせ • Apr 10Certara, Inc., Annual General Meeting, May 21, 2025Certara, Inc., Annual General Meeting, May 21, 2025.
お知らせ • Apr 02Certara Expands the Simcyp™ Simulator Platform Advancing Biopharmaceutics, Drug-Drug Interaction & Biologic CapabilitiesCertara, Inc. has released a new version of the Simcyp Simulator for physiologically-based pharmacokinetic (PBPK) modeling. Simcyp PBPK models describe and predict the behavior of drugs in different body tissues. The latest version includes numerous advancements to further support data-driven decision-making at every stage of development. A consortium of more than 30 leading pharmaceutical companies guides the development of the Simcyp Simulator. Version 24 incorporates their feedback, which enhances and expands existing capabilities and databases. Simcyp Simulator V24 features numerous updates, including: Biopharmaceutical capabilities and the Virtual Bioequivalence (VBE) module now include features for predicting food effects that improve the simulation of drug absorption under various meal conditions. Expanded library for drug-drug interactions (DDI): New and upgraded compound files for enzymes and transporters cover a broader range of DDI capabilities. These capabilities provide qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney. More precise characterization of the behavior of membrane-bound targets across various tissues and plasma in biologics models. These include soluble target movement and drug-target complex dynamics throughout the body, and refinements to the target shedding model. Further, nonlinear protein and plasma binding, and target-mediated drug disposition are incorporated for small molecules. Expanded Trial Design support: Enhanced speed and ease of use for designing and simulating clinical trials. Special Populations modeling: Enhanced and expanded capabilities for pediatric, pregnancy, and lactation populations. Performance and Usability: Modernized UI, cloud computing add-on, 'Ask Simcyp' AI-enabled help chat, and chemical structure-based parameter predictors. Routes of Administration: Improved functionality for long-acting injectables, inhalation, and ocular routes.
お知らせ • Mar 08Certara, Inc. Announces Step Down of Patrick F. Smith as President, Certara Drug Development SolutionsOn March 5, 2025, Certara, Inc. announced that Dr. Patrick F. Smith, President, Certara Drug Development Solutions, stepped down from that role as of March 3, 2025, but will remain employed by the Company in a senior advisory and scientific role.
お知らせ • Mar 06Certara, Inc. Appoints Adrian Mckemey as President of Drug Development SolutionsCertara, Inc. announced the appointment of Adrian McKemey, Ph.D. as President of Drug Development Solutions, effective March 3, 2025. In this role, McKemey will lead Certara's global team of drug development scientists. Adrian joins Certara after serving as head of Enterprise Transformation at IQVIA and Senior Vice President and Head of the R&D Strategy Solutions at Quintiles. He has over 25 years of experience in research and development roles where he focused on business transformation, portfolio management and R&D strategies. Before IQVIA, he was a Principal with the Boston Consulting Group (BCG) working in the Life Sciences practice in New York. He holds a BSc (First Class) and a PhD in High Energy Nuclear Particle Physics from the University of London. The change is part of a planned leadership transition. Patrick Smith, PharmD. will continue to support Certara’s growth in science and innovation as Senior Vice President of Translational Sciences. Patrick and his leadership team successfully led and integrated the Certara services team building a unified offering of comprehensive scientific services for life sciences clients across the globe.
お知らせ • Feb 27Certara, Inc. Provides Earnings Guidance for the Full Year 2025Certara, Inc. provided earnings guidance for the full year 2025. For the year, the company expects revenue to be in the range of $415 million to $425 million.
お知らせ • Jan 30Certara, Inc. to Report Q4, 2024 Results on Feb 26, 2025Certara, Inc. announced that they will report Q4, 2024 results After-Market on Feb 26, 2025
お知らせ • Jan 16Certara, Inc. Provides Preliminary Financial Guidance for the Fourth Quarter and Full Year Ended December 31, 2024Certara, Inc. provided preliminary financial guidance for the fourth quarter and full year ended December 31, 2024. Preliminary financials for the fourth quarter of 2024 are expected to be: revenue of $99.7 million, compared to $88.0 million in the fourth quarter of 2023, representing growth of 13%. Preliminary financials for the full year of 2024 are expected to be: Revenue of $384.4 million, compared to $354.3 million in 2023, representing growth of 8%.
お知らせ • Nov 07Certara, Inc. Updates Earnings Guidance for the Year 2024Certara, Inc. updated earnings guidance for the year 2024. For the year, revenue to be in the range of $380 million to $385 million.
お知らせ • Oct 17Certara, Inc. Appoints John Reynders as Independent Board MemberCertara, Inc. announced the appointment of John Reynders, PhD, to its Board of Directors, effective October 15, 2024. Dr. Reynders has over 25 years of experience in the pharmaceutical and tech industries. He was the founding CIO of Moderna where he led the data-sciences capabilities to design mRNA therapies. Most recently, he was Chief Data Sciences Officer at Neumora, a biotech focused on brain diseases. Before that, he held various executive positions leading data-sciences, informatics, and technology organizations at Alexion Pharmaceuticals, AstraZeneca, Johnson & Johnson, Eli Lilly, and Celera.
お知らせ • Oct 10Certara, Inc. to Report Q3, 2024 Results on Nov 06, 2024Certara, Inc. announced that they will report Q3, 2024 results After-Market on Nov 06, 2024
お知らせ • Oct 04Certara, Inc. (NasdaqGS:CERT) completed the acquisition of ChemAxon Kft.Certara, Inc. (NasdaqGS:CERT) signed a definitive agreement to acquire ChemAxon Kft. on July 9, 2024. The transaction is subject to approval by regulatory and other customary closing conditions. The transaction is expected to close in the second half of 2024. Certara, Inc. (NasdaqGS:CERT) completed the acquisition of ChemAxon Kft. on October 2, 2024.
お知らせ • Aug 16Certara, Inc. Launches Phoenix™ Version 8.5 Drug Development SoftwareCertara, Inc. announced the launch of Phoenix™ version 8.5. Phoenix is the pharmaceutical industry's gold standard in pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic modeling and simulation software. The Phoenix Platform is used by more than 75 of the top 100 pharmaceutical companies worldwide. Eleven regulatory agencies, including the U.S. FDA, Japan PMDA, and China NMPA, rely on Phoenix to evaluate life-saving drug candidates. Version 8.5 is the latest release from Certara’s Phoenix Platform, available as a hosted solution for maximum performance and lower total cost of ownership. Today, 88% of new medicines that enter clinical trials fail, indicating a need for improved processes. Certara’s Phoenix platform expedites everything from data preparation to report generation – a time-consuming process that drug developers rely on. Version 8.5 delivers new features driven by customer demand. These features improve the efficiency, quality, and speed of PK/PD workflows within Phoenix. Sign-in via Certara Cloud - Phoenix 8.5 introduces user sign-in via Certara Central Admin, offering Single Sign-On and centralized authentication. This simplifies license management, streamlines assignments, enhances access control, and improves the user experience by providing easier access to resources, training and support. Reporting Enhancements for Tables, Plotting, Reporting: Updates are designed to offer increased customization and efficiency in data presentation in tables and plots, along with advancing capabilities for visual data analysis. These improvements aim to streamline the reporting process and enable more detailed and readily interpretable reports. NLME (Non-linear mixed effects) Enhancements: Phoenix NLME is a population modeling and simulation software solution for scientists with varying levels of experience—from novice PK/PD scientists to the most advanced modelers. The 8.5 update improves the precision of modeling, increases the adaptability for users, and provides tools to enhance the interpretability of models.
お知らせ • Aug 07Certara, Inc. Reiterates Earnings Guidance for the Year 2024Certara, Inc. reiterated earnings guidance for the year 2024. For the year, the company expects full year 2024 revenue to be in the range of $385 million to $400 million.
お知らせ • Jul 10Certara, Inc. (NasdaqGS:CERT)signed a definitive agreement to acquire ChemAxon Kft.Certara, Inc. (NasdaqGS:CERT)signed a definitive agreement to acquire ChemAxon Kft. on July 9, 2024. The transaction is subject to approval by regulatory and other customary closing conditions. The transaction is expected to close in the second half of 2024.
お知らせ • Jul 04Certara, Inc. to Report Q2, 2024 Results on Aug 06, 2024Certara, Inc. announced that they will report Q2, 2024 results After-Market on Aug 06, 2024
お知らせ • Jun 18Certara Launches Next Generation CoAuthor™ Generative AI Regulatory Writing SoftwareCertara, Inc. unveiled its next-generation CoAuthor regulatory writing software. CoAuthor is an advanced writing platform designed for medical writers. It combines generative AI, document templates, Microsoft Word integration, and structured content authoring tools. CoAuthor accelerates the creation of regulatory documents while maintaining a “human in the loop” approach to the use of generative AI. Medical writing is a critical part of drug development. It relies on manual processes which have not changed significantly over the past two decades. Drug development pipelines increasingly comprise precision medicine therapies that depend on advanced biomedical knowledge. Today’s medical writers must translate complex study designs and data into documents that contextualize research results for different audiences. They need better ways to synthesize numerous sources of knowledge and securely connect them to their data and documents. Built by writers, for writers, CoAuthor is easy to use and combines a life science specialized, secure, client-specific GPT with structured content authoring and comprehensive eCTD regulatory writing templates. With CoAuthor, medical writers can streamline the document drafting process, allowing more time for content curation, collaboration, and quality control. Fully integrated with Microsoft Word, CoAuthor enables writing teams to use familiar tools, systems, and processes while ensuring consistency and quality. Certara clients will have the flexibility to work with CoAuthor as part of a comprehensive regulatory writing solution, at the program level and across the enterprise.
お知らせ • May 22Certara, Inc Appoints Rona Anhalt as Chief Human Resources Officer and Daniel Corcoran as General CounselCertara, Inc. has appointed Rona Anhalt as Chief Human Resources Officer and Daniel Corcoran as General Counsel. Ms. Anhalt will drive Certara’s human capital management strategy. She will lead the company’s global Human Resources function supporting Certara’s 1,400 team members including more than 400 scientists across the globe. She has over 20 years of experience supporting strategic growth and building high-performing teams in life sciences. In her prior role at EQRx, Ms. Anhalt led HR from start-up through acquisition and championed a mission-oriented culture. Daniel Corcoran will oversee Certara’s legal affairs. He has over 20 years of experience in publicly traded and privately held global technology companies. Previously, he was the Senior Vice President of Legal and General Counsel at Nexthink where he led legal and compliance teams and helped the company prepare for its IPO.
お知らせ • May 09Certara, Inc. Reiterates Earnings Guidance for the Year 2024Certara, Inc. reiterated earnings guidance for the year 2024. For the year, the company expects revenue to be in the range of $385 million to $400 million.
お知らせ • Apr 16Certara, Inc. Launches Cloud Platform to Further Unify Its End-To-End Scientific Software PlatformCertara, Inc. announced the launch of Certara Cloud, the unifying platform that integrates its many scientific software solutions. Customers log into Certara Cloud using a single ID to access and manage their licensed software, linking predictive solutions to modeling and analysis of clinical trial results. Certara Cloud delivers value and unique capabilities across several areas of immediate benefit and lays the foundation for future advanced operations, including: Real-time collaboration across internal teams and external partners with reduced friction in deployment, licensing, and technical implementation. Centralized security and IT administration, leveraging Single Sign On and cross-product user management and auditing functions. Best practices documentation and media-rich educational resources from thought leaders spanning all stages of drug development including complimentary access to the gold standard PK/PD e-book, Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications. Cross-functional insights and benchmarks for clients, derived from following their drug candidate across its various stops in the Certara ecosystem. Certara Cloud is following a phased roll-out over 2024 with over 1,500 client-specific portals already prepared and is currently in use by fifteen of the top 30 biopharmaceutical companies.
お知らせ • Apr 11Certara, Inc., Annual General Meeting, May 21, 2024Certara, Inc., Annual General Meeting, May 21, 2024, at 09:00 US Eastern Standard Time. Agenda: To consider election of Class I directors; to approve two separate proposals to amend our Amended and Restated Certificate of Incorporation ; to Amend our Certificate of Incorporation to limit the liability of certain officers of Certara as permitted pursuant to the Delaware General Corporation Law; to Amend our Certificate of Incorporation to make certain technical changes, including to remove inoperative provisions related to our former majority stockholder and other immaterial changes; to Ratification of the appointment of independent registered public accounting firm for the fiscal year ending December 31, 2024; and to conduct a non-binding advisory vote to approve the compensation of our named executive officers.
お知らせ • Apr 10Certara, Inc. to Report Q1, 2024 Results on May 07, 2024Certara, Inc. announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 07, 2024
お知らせ • Mar 01Certara, Inc. Provides Earnings Guidance for the Year 2024Certara, Inc. provided earnings guidance for the year 2024. For the year, the company expects revenue to be in the range of $385 million to $400 million.
お知らせ • Feb 02Certara, Inc. to Report Q4, 2023 Results on Feb 29, 2024Certara, Inc. announced that they will report Q4, 2023 results After-Market on Feb 29, 2024
お知らせ • Dec 14Certara, Inc. (NasdaqGS : CERT) acquired Applied BioMath, LLC.Certara, Inc. (NasdaqGS : CERT) acquired Applied BioMath, LLC on December 13, 2023.Certara, Inc. (NasdaqGS : CERT) completed the acquisition of Applied BioMath, LLC on December 13, 2023.
お知らせ • Nov 22Certara, Inc. Announces the Introduction of Simcyp Biopharmaceutics SoftwareCertara, Inc. announced the introduction of Simcyp™? Biopharmaceutics software. It is designed for use by biopharmaceutic, formulation, and CMC scientists to aid in formulating complex novel and generic small molecule medicines quickly and cost effectively. Simcyp Biopharmaceutics software is part of the Simcyp Simulator biosimulation platform, which has supported label claims for more than 100 approved novel therapies. Simcyp Biopharmaceutics software also helps sponsors develop the evidence needed to attain biowaivers which are used in lieu of conducting clinical studies. It is available as a standalone product and is designed for life sciences companies of all sizes looking to optimize their therapies’ formulations to maximize safety, efficacy, and patient convenience. Simcyp Biopharmaceutics software delivers value and unique capabilities across several areas that are critical to achieving formulation success, including: Replace Costly Clinical Bioequivalence Studies - With growing encouragement from regulators, virtual bioequivalence studies (VBE) leverages physiologically based pharmacokinetic (PBPK) modeling to demonstrate bioequivalence (BE) between test and reference drugs. Simcyp Biopharmaceutics software includes a VBE module that automates elements of trial design significantly enhancing opportunities for attaining biowaivers. Optimize Formulation for Complex Drugs: Biopharmaceutical Classification System (BCS) Class II-IV drugs are challenging to create oral formulations for because of their poor solubility and/or absorption. Simcyp Biopharmaceutics software facilitates developing these drugs, which constitute 90% of new drug candidates. Inform Drug Labels - Recent FDA guidance recognizes physiologically-based pharmacokinetic (PBPK) models as a valuable technology for identifying and optimizing the impact of gastrointestinal effects such as meal type and pH. Simcyp Biopharmaceutics software advances these capabilities for optimizing dosing strategies and providing label guidance to clinicians.
お知らせ • Nov 10Certara, Inc. Provides Revenue Guidance for the Year 2023Certara, Inc. provided revenue guidance for the year 2023. For the year, the company expects revenue to be in the range of $345 million to $360 million.
お知らせ • Oct 12Certara, Inc. to Report Q3, 2023 Results on Nov 08, 2023Certara, Inc. announced that they will report Q3, 2023 results After-Market on Nov 08, 2023
お知らせ • Aug 10Certara, Inc. Updates Earnings Guidance for the Year 2023Certara, Inc. updated earnings guidance for the year 2023. The company is updating its previously reported guidance for full year 2023. The company expects full year 2023 revenue to be in the range of $345 million to $360 million.
お知らせ • Jul 14Certara, Inc. to Report Q2, 2023 Results on Aug 09, 2023Certara, Inc. announced that they will report Q2, 2023 results After-Market on Aug 09, 2023
お知らせ • May 09Certara, Inc. Provides Revenue Guidance for the Year 2023Certara, Inc. provided revenue guidance for the year 2023. For the full year 2023, the company expects revenue to be in the range of $370 million to $385 million.
お知らせ • Feb 02Certara, Inc. to Report Q4, 2022 Results on Mar 01, 2023Certara, Inc. announced that they will report Q4, 2022 results After-Market on Mar 01, 2023
Breakeven Date Change • Jan 31Forecast breakeven date pushed back to 2023The 8 analysts covering Certara previously expected the company to break even in 2022. New consensus forecast suggests the company will make a profit of US$21.3m in 2023. Average annual earnings growth of 59% is required to achieve expected profit on schedule.