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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, a leader in biosimulation, expands its Integrated Drug Development division with a new clinical science group led by Philippa Marshall, M.D. This expansion includes important appointments: David Mitchell, Ph.D., as Senior Vice President of Strategic Engagement, and C. Glenn Begley, M.D., Ph.D., and Colin Pillai, Ph.D., as Senior Scientific Advisors. These strategic hires aim to deepen expertise in model-informed drug development and enhance partnerships with various stakeholders, further positioning Certara in the biopharmaceutical sector.
Certara Receives FDA Grant for Biosimulation Model
On September 20, 2021, Certara (Nasdaq: CERT) announced the award of a U.S. FDA grant to enhance its Simcyp MechDermA™ model for assessing virtual bioequivalence in generic drug development. This is the fourth grant awarded to Certara for this purpose. The project aims to verify the predictive performance of biosimulation models, ensuring safer and cost-effective drug development. The Simcyp model previously demonstrated bioequivalence for diclofenac sodium topical gel in 2019, helping to streamline clinical trial requirements.
Certara, Inc. (Nasdaq: CERT) announced the successful closure of its public offering, selling 23,000,000 shares at $31.00 each, generating approximately $139.5 million in gross proceeds. This total includes an additional 3,000,000 shares from underwriters' option. Certara sold 4,500,000 shares while selling stockholders contributed 18,500,000 shares. The proceeds will be utilized for general corporate purposes, including acquisitions. The offering was managed by Jefferies, Morgan Stanley, and BofA Securities, among others.
Certara, Inc. (Nasdaq: CERT) has announced its public offering of 4.5 million shares, priced at $31.00 each, aiming for gross proceeds of approximately $139.5 million. Additionally, existing stockholders are offering 15.5 million shares, with underwriters given a 30-day option for an extra 3 million shares. The net proceeds will support general corporate purposes, including acquisitions. The offering is led by Jefferies, Morgan Stanley, and BofA Securities, with closing expected on or around September 13, 2021.
Certara, Inc. (Nasdaq: CERT) announced a proposed underwritten public offering of 20 million shares of its common stock. Certara aims to offer 4.5 million shares directly, while selling stockholders will offer 15.5 million shares. Additionally, there is a potential for underwriters to purchase up to 3 million additional shares. The net proceeds from the shares offered by Certara will be used for general corporate purposes including acquisitions. The offering is led by Jefferies, Morgan Stanley, and BofA Securities.
Certara, a leader in biosimulation, announced participation in upcoming virtual investor conferences. Key events include the Morgan Stanley Global Healthcare Conference on September 14 at 9:30 a.m. ET, featuring CEO William Feehery and CFO Andrew Schemick; the Baird Global Healthcare Conference on September 15 at 4:55 p.m. ET, with CFO Andrew Schemick; and the Bank of America Securities Drug Discovery Conference on September 20 at 8:00 a.m. ET, with both executives. Live webcasts will be available on Certara’s investor relations website for 90 days.
Certara, Inc. (Nasdaq: CERT) reported Q2 2021 revenue of $70.1 million, a 15% increase year-over-year. Net loss was $2.9 million, contrasting with a net income of $2.8 million in Q2 2020. Adjusted EBITDA rose 1% to $25.5 million. The company announced the acquisition of Pinnacle 21 for $310 million, aimed at enhancing its data standardization capabilities. Full year 2021 guidance was raised to $283-$289 million in revenue, $101-$103 million in Adjusted EBITDA, and $0.21-$0.25 in Adjusted Diluted EPS, excluding Pinnacle 21's impact.
Certara, Inc. (Nasdaq: CERT) has announced a definitive agreement to acquire Pinnacle 21 for $310 million in cash and stock. The acquisition, aimed at enhancing Certara's biosimulation and regulatory software capabilities, is expected to be immediately accretive to revenue and adjusted EBITDA margins. Pinnacle 21's tools ensure compliance with CDISC standards, crucial for FDA and PMDA drug submissions. The deal, which has been unanimously approved, is expected to close by early Q4 2021, subject to regulatory approvals.
Certara (NASDAQ: CERT) has announced a $250 million investment from Mubadala Investment Company, with shares priced at $26 each. The transaction includes the purchase of 9,615,384 shares from existing shareholders, expected to close on August 2, 2021. CEO William F. Feehery expressed enthusiasm for Mubadala's support, highlighting Certara's leadership in biosimulation. Mubadala's investment aims to enhance innovation in clinical needs and improve drug development processes. With over 1,650 clients globally, Certara continues to advance biopharma research and development.
Certara has confirmed through the Pitch study at Oxford University that its Vaccine Simulator predicted an optimal eight-week interval between COVID-19 vaccine doses. This finding challenges the existing dosing schedules of Pfizer-BioNTech and Moderna, which recommend three and four weeks, respectively. Certara's biosimulation technology integrates various data to optimize dosing strategies, aiding in global health efforts amidst the pandemic. The company aims to enhance vaccine efficacy and safety, including future booster recommendations and mixing vaccines.
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