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) is a software‑driven company in the model‑informed drug development and biosimulation space. The CERT news page on Stock Titan aggregates company‑specific headlines so readers can follow how Certara’s biosimulation software, technology, and services are discussed in earnings releases, product announcements, scientific updates, and corporate events.
Recent Certara news highlights several recurring themes. The company issues quarterly financial results that describe revenue from biosimulation software and services, bookings trends, and updates to its full‑year financial outlook. These results are typically accompanied by commentary on demand for model‑informed drug development solutions and the performance of its software and services portfolio.
Certara also regularly announces new software capabilities and platform enhancements. Examples in recent releases include the launch of Certara IQ, an AI‑powered quantitative systems pharmacology solution, and TFL Studio, the first cloud‑native module of its Phoenix Cloud platform for pharmacokinetic and pharmacodynamic workflows. The company has additionally introduced Pinnacle 21 Enterprise Plus for managing CDISC SDTM and ADaM data specifications used in regulatory submissions.
Another category of news involves scientific recognition and research output, such as announcements about Certara scientists being listed among highly cited researchers and the publication of hundreds of scientific papers in a year. Corporate governance and leadership updates, including changes in the chief executive officer role, appear in both press releases and related SEC filings.
Investors, analysts, and industry professionals can use this news feed to monitor Certara’s financial disclosures, product roadmap, scientific contributions, and capital markets activity over time.
Certara, Inc. (Nasdaq: CERT) has announced the appointment of James E. Cashman III as Chairman of the Board, effective December 1, 2021. He will succeed Sherilyn McCoy, who is stepping down to focus on other commitments. Cashman, who has served on Certara's Board since 2018, previously led ANSYS, growing its revenue from $50 million to over $1 billion. His expertise in simulation-driven product development is expected to strengthen Certara's innovation and growth strategy. The company specializes in biosimulation technologies enhancing drug development.
Certara, a leader in biosimulation, announced that its CEO, William F. Feehery, and CFO, Andrew Schemick, will participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference. The event is scheduled for November 22, 2021, at 10:00 am ET. Interested parties can access the webcast through Certara's investor relations website. Certara is known for its proprietary biosimulation software, serving over 1,650 global biopharmaceutical firms, academic institutions, and regulatory agencies across 61 countries.
Certara (Nasdaq: CERT) has secured a five-year contract from the FDA for its Pinnacle 21 Enterprise software, which enhances the agency's ability to review clinical and non-clinical study submission data. This agreement continues a long-standing partnership and follows previous contracts awarded in 2011 and 2015. The software streamlines data validation processes, allowing FDA reviewers to assess data quality more efficiently. This contract also supports the FDA’s DataFit program amid new technical rejection criteria implementation.
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Certara, Inc. (Nasdaq: CERT) will release its third-quarter 2021 financial results on November 9, 2021, post-market. A conference call with management to discuss these results will occur at 5:00 p.m. ET. Interested investors can join the call by dialing (833) 360-0946 for domestic and (914) 987-7661 for international participants, using Conference ID: 1968232. The event will also be available via a live and archived webcast on Certara's Investors webpage.
Certara specializes in biosimulation software and technology, assisting over 1,650 clients globally.
Certara, Inc. (Nasdaq: CERT) has appointed Patrick F. Smith, Pharm.D., as the new president of Integrated Drug Development (IDD). He succeeds Craig R. Rayner, Pharm.D., who will transition to a role as a distinguished scientist. Dr. Smith brings extensive experience in drug development, particularly in infectious diseases and oncology, having previously served as senior vice president of IDD strategy and innovation. His leadership aims to enhance Certara's biosimulation and quantitative approaches across the drug development life cycle, positioning the company for continued growth.
Certara Appoints New Chief Commercial Officer
On October 5, 2021, Certara (Nasdaq: CERT) announced the appointment of Drayton T. Virkler as Chief Commercial Officer. With over 20 years of experience in the pharma sector, Virkler's role focuses on enhancing global commercial strategies and business development. Previously at IQVIA, he led sales and marketing, achieving annual revenue growth. Virkler aims to broaden Certara’s reach in biosimulation technologies, ultimately improving drug development processes for clients worldwide.
Certara has successfully acquired Pinnacle 21 for approximately $250 million in cash and 2.24 million shares of restricted common stock. This strategic acquisition aims to enhance Certara's capabilities in clinical data management and regulatory compliance, crucial for expediting drug development. Pinnacle 21's software is already adopted by leading biopharmaceutical companies and regulatory agencies like the FDA. The acquisition is expected to boost Certara's revenue and adjusted EBITDA, with updated financial guidance anticipated in November 2021.
Certara has launched Synchrogenix Writer, a cloud-based regulatory SaaS product aimed at automating and improving the quality of patient narratives critical for clinical study reporting. This innovative solution addresses the inefficiencies of the traditional manual writing process, which is costly and time-consuming. By enabling data-mapping and early drafting, the software ensures consistency, reduces risk, and accelerates the time to regulatory filing. With over 10,000 patient narratives already delivered, Synchrogenix Writer is positioned to meet evolving global regulatory requirements.
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.