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Certara, Inc. (NASDAQ: CERT) is a leading provider of decision support technology and consulting services designed to optimize drug development and improve health outcomes. The company's suite of solutions spans the entire drug development and patient care lifecycle, employing advanced modeling and simulation technologies along with cutting-edge regulatory strategies. Certara's services are pivotal in increasing the probability of both regulatory and commercial success for their clients, which include over 2,300 global biopharmaceutical companies, leading academic institutions, and major regulatory agencies across 70 countries.
Certara's core business revolves around leveraging biosimulation software and technology to transform traditional drug discovery and development processes. By using its innovative modeling and simulation tools, the company aids clients in reducing the need for extensive clinical trials, thereby accelerating regulatory approvals and enhancing patient access to new therapies. Their product suite includes regulatory science, assessment software, and a range of consulting services, all aimed at streamlining drug development.
One of Certara's notable achievements is its collaboration with the FDA on physiologically-based pharmacokinetic (PBPK) modeling for virtual bioequivalence (VBE) and predicting drug absorption of topical formulations. These initiatives aim to replace costly and time-consuming clinical bioequivalence studies with efficient virtual simulations, thus speeding up the development process and reducing costs. The Simcyp Simulator, a key component of Certara's technology, has already proven its utility in replacing clinical studies in VBE and dermal absorption scenarios.
Certara's business operations are primarily concentrated in the Americas, generating significant revenue from this region, with additional market presence in EMEA and the Asia Pacific. The company continues to expand its software portfolio with innovations like the Simcyp™ Biopharmaceutics software, which helps drug developers optimize formulations for complex therapies, and the recently launched Certara Cloud, a unified platform that integrates their scientific software solutions for seamless workflow management.
Financially, Certara has reiterated its full-year guidance for 2024, showcasing a stable outlook and ongoing commitment to delivering high-quality, innovative solutions. Their recent acquisition of Applied BioMath underscores their growth strategy, enhancing their capabilities in quantitative systems pharmacology (QSP) to de-risk and accelerate therapeutic R&D. The combined expertise positions Certara as the largest QSP center of excellence, further strengthening their role in the life sciences industry.
For more information, visit www.certara.com.
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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