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.
Certara, Inc. (NASDAQ: CERT) delivers biosimulation solutions and model-informed drug development services that accelerate pharmaceutical innovation. This page provides comprehensive coverage of Certara's latest news, including regulatory milestones, strategic partnerships, and advancements in simulation technology.
Investors and industry professionals will find timely updates on earnings reports, product launches, and scientific developments shaping the drug development landscape. Our curated collection features press releases on regulatory submissions, technology platform enhancements, and collaborations with biopharma leaders.
Key focus areas include Certara's biosimulation software updates, regulatory science achievements, and innovations in quantitative pharmacology. Bookmark this page to stay informed about developments impacting clinical trial optimization and global drug approval processes.
Certara, Inc. (Nasdaq: CERT) reported Q4 2021 revenue of $75.3 million, a 17% increase from Q4 2020. Excluding Pinnacle 21, revenue grew 7%. The net loss narrowed to $9.7 million from $54.5 million year-over-year, while adjusted EBITDA rose 27% to $28.2 million. For 2021, total revenue reached $286.1 million, up 17% year-over-year. However, 2022 revenue guidance was revised down to $350-$360 million. The company is confident in its mid-teens growth target despite challenges from the Omicron variant.
Certara announces FDA licensing of its Immunogenicity (IG) Simulator, enhancing drug development capabilities. The simulator predicts immune responses in protein therapeutics, crucial for clinical and regulatory decisions. With over five years of rigorous development, Certara aims to address immunogenicity risks, which can significantly impact drug projects. This technology is validated through 20 clinical studies, facilitating virtual patient trials. Certara serves over 2,000 clients globally, underscoring its role as a leader in biosimulation.
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.
