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. reports developments in model-informed drug development, combining biosimulation software, technology and services for drug discovery, clinical development and regulatory science. Company news frequently centers on quarterly results, revenue mix between software and services, guidance updates and operating changes following the completed divestiture of its global medical writing and related regulatory services business.
Recurring updates also cover strategic partnerships with drug-development service providers and the use of Certara's Simcyp® Simulator for physiologically based pharmacokinetic modeling. These announcements describe biosimulation applications in clinical pharmacology, new drug applications and regulatory decision-making for biopharmaceutical, academic and agency clients.
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Certara's Leadership in Drug Approvals
On April 27, 2023, Certara, Inc. (Nasdaq: CERT) announced that its clients achieved a remarkable milestone, with 90% of new drug approvals from the FDA's CDER in 2022. This marks the ninth consecutive year of significant FDA approvals for Certara’s clients, using its innovative biosimulation software across multiple therapeutic areas, including oncology and rare diseases.
Certara's Simcyp™ and Phoenix™ software have been instrumental in informing drug label claims and evaluating drug applications, respectively. Notably, these tools aided in the approval of eight oncology drugs among other critical treatments, reflecting Certara's commitment to enhancing drug development efficiency and safety for patients worldwide.
Certara, Inc. (Nasdaq: CERT) announced it will release its financial results for Q1 2023 after market close on May 8, 2023. A conference call is scheduled for 5:00 PM ET the same day, where company management will discuss the results. Investors can register for the call online, with an early registration recommended. Additionally, Certara will participate in the BofA Securities 2023 Healthcare Conference, presenting on May 10, 2023, at 8:40 AM PT. Live and archived webcasts from both events will be accessible on the Certara Investors website.
Certara specializes in biosimulation, providing software and services for drug discovery and development, with a client base exceeding 2,000 organizations globally.
Xentria, Inc. has announced a peer-reviewed publication in Frontiers in Pharmacology, detailing a biosimulation model for its treatment candidate, XTMAB-16, aimed at pulmonary sarcoidosis. Partnering with Certara, Inc., the model aids in estimating safe and effective dosing for upcoming clinical trials slated for early 2023. XTMAB-16, an anti-TNF monoclonal antibody, has shown promise in reducing granuloma formation. The publication represents a significant collaboration in sarcoidosis research, potentially marking the first use of an in vitro model to guide dosing in clinical trials. Xentria aims to launch its first patient trial soon.
Certara has announced the integration of deep learning capabilities into its scientific informatics software platform, D360. This enhancement aims to improve data-driven decision-making in drug discovery by allowing users to predict properties of chemical structures and access unstructured data. The new features include Automated Property Prediction, Novel Structure Generation, and enhanced access to literature-based insights. Certara acquired these advanced capabilities from Vyasa and will showcase them at the Lab of the Future Congress in Boston.
Certara, Inc. (CERT) announced the launch of Simcyp Simulator Version 22, enhancing its capabilities for drug development. This advanced platform has been utilized to support over 300 label claims for more than 90 FDA-approved novel drugs, allowing for comprehensive analysis without human clinical trials. Key upgrades include enhanced subcutaneous dosing predictions, expanded compound libraries, and additional ethnic populations for improved therapeutic applications. Certara aims to facilitate faster medicine delivery through its continuing commitment to advanced biosimulation technologies.