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) operates in the biosimulation software and drug development services sector, making its news particularly relevant for investors tracking pharmaceutical technology trends and regulatory science developments.
As a company serving the biopharmaceutical industry, Certara's news flow typically includes quarterly earnings reports that detail software subscription growth and services revenue, product announcements for platform expansions and new simulation capabilities, and strategic partnerships with pharmaceutical companies and regulatory agencies.
The nature of Certara's business means significant news events often relate to regulatory milestones, such as platform qualifications from the FDA or European Medicines Agency, which validate the company's technology for use in drug approval submissions. These regulatory endorsements can expand the addressable market for Certara's platforms.
Investors following Certara should also monitor announcements regarding customer expansions, particularly deals with large pharmaceutical companies that could indicate growing adoption of biosimulation approaches in drug development. Technology collaborations and acquisitions that expand platform capabilities represent another category of material news for the company.
Bookmark this page to track Certara's earnings releases, product launches, regulatory developments, and strategic announcements that may impact the company's position in the life sciences technology market.
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.
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