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.
Certara announced that in 2021, 90% of new drug approvals from the FDA’s CDER were achieved by its customers, marking the eighth consecutive year of success in drug approval for clients utilizing its biosimulation software. The company’s Simcyp™ Simulator played a significant role in providing prescribing information for 13 new drugs, thereby reducing clinical trial costs and durations. Certara's technology has been instrumental in supporting the approval process for various therapeutic areas including oncology and orphan diseases, reinforcing its position as a leader in drug development.
Certara, Inc. (Nasdaq: CERT) will announce its fourth quarter and full year 2021 financial results after market close on March 1, 2022. A conference call hosted by company management will take place at 5:00 p.m. ET to discuss these results. Investors can join the call by dialing (833) 360-0946 for domestic calls or (914) 987-7661 for international calls, using Conference ID: 4688502. Additionally, a live and archived webcast of the call will be available on Certara's investor relations website.
Certara, a leader in biosimulation, announced on December 21, 2021, that the FDA has renewed and expanded its licenses for more than 400 user licenses of Certara's Simcyp and Phoenix software across 12 divisions. This software plays a critical role in drug development, helping the FDA analyze investigational therapies, new drug applications, and generic applications. The renewal indicates the FDA's growing reliance on Certara's tools, which are used by 37 of the top 40 biopharmaceutical companies. This expansion reflects Certara's influential position in ensuring the safety and efficacy of medicines.
Certara has announced the release of Pinnacle 21 Enterprise 5.1.0, enhancing its capabilities for biopharmaceutical clients. This update focuses on improving clinical trial data preparation for regulatory submissions, aligning with CDISC standards. The new features include support for the Define-XML 2.1 standard and an analytics module for summarizing portfolio performance. Major biopharmaceutical companies and regulatory bodies, such as the US FDA, utilize this software, indicating its critical role in accelerating time-to-market for medical products.
Certara, a leader in biosimulation, will host an Investor Day on December 15, 2021, from 3:00 PM to 6:00 PM ET in New York City. During this event, the management team will share updates on the company's strategy, software, and financial guidance for 2022. A demonstration of the Simcyp™ Simulator will also take place. The event will be available via a live video webcast on Certara's Investor Relations website, and a replay will be accessible for two weeks post-event.
Certara, a leader in biosimulation, announced the release of Simcyp Simulator Version 21, enhancing its population-based modeling platform. This tool aids in drug development by predicting dosing and drug-drug interactions without extensive clinical trials. The simulator has informed over 250 label claims for 85+ novel drugs approved by the FDA. New features include updates for renal and hepatic models, expanded brain models, and a broadened compound library. These advancements align with FDA guidance, facilitating faster drug approvals.
Certara, Inc. (Nasdaq: CERT) has launched D360 version 21.5, enhancing its scientific informatics software for biomedical research. This update improves efficiency in analyzing small molecules and biologic drugs, facilitating quicker, higher-confidence decision-making in drug development. Key new features include support for biologic drug sequence clustering, transformation analysis for small molecules, accelerated workflows, and advanced data visualization. D360 is utilized by over 6,000 scientists at top biopharmaceutical firms, reaffirming Certara's commitment to optimizing drug discovery processes.
Certara, Inc. (Nasdaq: CERT) has closed its public offering of 10,000,000 shares at $31.00 each, undertaken by existing stockholders. The underwriters were granted a 30-day option for an additional 1,500,000 shares. Certara will not receive any proceeds from this sale. The offering was led by Jefferies, Morgan Stanley, and BofA Securities, with other firms participating. A registration statement relating to these securities was approved by the SEC. Full prospectus details are available upon request from the underwriting firms.
Certara, a leader in biosimulation, announced the pricing of an underwritten public offering of 10 million shares at $31.00 each, solely by existing stockholders. The underwriters have a 30-day option to purchase an additional 1.5 million shares. Certara will not receive proceeds from this offering, which is expected to close on November 22, 2021. This offering is managed by Jefferies, Morgan Stanley, and BofA Securities, among others. A registration statement has been declared effective by the SEC.
Certara has announced a proposed underwritten public offering of 10 million shares of its common stock by certain selling stockholders, as per the registration statement filed with the Securities and Exchange Commission. The underwriters will have a 30-day option to purchase an additional 1.5 million shares. Certara will not receive any proceeds from this offering. The underwriting group includes Jefferies, Morgan Stanley, and BofA Securities. A preliminary prospectus has been filed but is subject to completion and will not be effective until registration formalities are met.
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