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 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 has appointed Nicolette D. Sherman as Chief Human Resources Officer, bringing over 20 years of HR experience in the biopharmaceutical sector. Previously, she was CHRO at Oyster Point Pharma, where she developed HR strategies for a newly public biotech. Her tenure at Sanofi included roles as Vice President of North American HR Operations and Global Leadership Development. CEO William F. Feehery expressed confidence in Sherman's ability to enhance Certara's capabilities and corporate values, further aligning with the company's mission to transform drug development.
Certara has launched an upgraded version of its BaseCase software, aimed at enhancing the market potential for biopharmaceutical and medical device companies. The new capabilities, which include Data Connect for real-time data updates, aim to improve communications regarding product value. The software is currently utilized in over 60 countries by more than 30,000 users, including leading global firms. This development reflects a strategic move to strengthen Certara’s position in the value-based healthcare sector, providing tools for effective market access and medical affairs.
Certara announced the renewal of its licenses for biosimulation software by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the eighth consecutive year. The PMDA has utilized Certara’s Simcyp™ and Phoenix™ software since 2014. These tools aid in drug development by optimizing dosing regimens and predicting interactions. Certara collaborates with over 130 biopharmaceutical firms in Japan, including the top 10 by R&D expenditure. The continued adoption of biosimulation supports the development of therapies for challenging diseases.
Certara has appointed Carol Gallagher, Pharm.D., to its board of directors, enhancing its governance with her 30+ years of drug development and commercial leadership experience.
Previously a CEO and venture partner, Dr. Gallagher has a notable background in biopharmaceuticals, including her role in developing the cancer drug ZYDELIG. Her experience spans companies like Eli Lilly and Amgen.
Dr. Gallagher's addition is expected to contribute to Certara's mission to accelerate drug development through its biosimulation software, supporting over 1,650 global clients.
Certara, Inc. (Nasdaq: CERT) announced participation in upcoming virtual investor conferences featuring CEO William Feehery and CFO Andrew Schemick. They will speak at William Blair's 41st Annual Growth Stock Conference on June 1 at 11:40 a.m. ET and the Jefferies Virtual Healthcare Conference on June 4 at 10:00 a.m. ET. Live webcasts will be available on Certara's investor relations website and can be replayed for 90 days. Certara specializes in biosimulation software to enhance drug discovery and development for over 1,650 global clients.
Certara has launched new versions of its Immunogenicity and Immuno-oncology Quantitative Systems Pharmacology (QSP) Simulators to tackle challenges in developing biologics and cancer therapies. The updates enhance the simulators' capabilities, allowing for better predictions of clinical outcomes and the testing of therapy combinations. Certara's tools are now critical in regulatory submissions, highlighting the growing importance of QSP in pharmaceutical R&D. The simulators have successfully predicted outcomes for various cancer treatment scenarios, including solid tumors and blood cancers.
Certara reported Q1 fiscal 2021 results with revenue of $66.7 million, a 16% increase from Q1 2020. Net income rose to $1.1 million, with adjusted EBITDA climbing 20% to $23.9 million. The company updated its full-year guidance, projecting revenue between $277 million and $285 million, and adjusted EBITDA of $100 million to $102 million. First quarter bookings grew 34% year-over-year, indicating strong demand for its biosimulation platform.
Certara has launched its innovative Secondary Intelligence™ software, designed to predict off-target safety issues that could affect drug development. This software is the first of its kind, providing critical data on secondary pharmacology and enhancing decision-making for drug developers. With safety issues contributing to around 25% of candidate failures, this tool aims to improve the efficiency and precision of safety assessments, potentially accelerating clinical success. Certara serves over 1,650 clients in 61 countries, highlighting its significant role in the biopharmaceutical sector.
Certara, Inc. (Nasdaq: CERT), a leader in biosimulation, announced its participation in the BofA Securities 2021 Virtual Health Care Conference. The presentation will be led by CEO William Feehery and CFO Andrew Schemick on May 11, 2021, at 2:45 p.m. ET. A live webcast will be available on Certara’s investor relations website, with a replay option for 90 days. Certara specializes in accelerating drug discovery and development through innovative biosimulation technology, serving over 1,650 clients globally, including major biopharmaceutical firms and regulatory agencies.
Certara, Inc. (Nasdaq: CERT) announced it will release preliminary financial results for Q1 2021 on May 6, 2021, after market close. A conference call will follow at 5:00 p.m. ET for management to discuss these results. Investors can participate via phone or listen to the archived webcast on Certara's website. Certara specializes in biosimulation software, serving over 1,650 biopharmaceutical companies and regulatory agencies worldwide, enhancing drug discovery and development processes.
FAQ
What is the current stock price of Certara (CERT)?
What is the market cap of Certara (CERT)?
What does Certara, Inc. specialize in?
Who are Certara's clients?
What is the Simcyp Simulator used for?
What are some recent achievements of Certara?
In which regions does Certara operate?
How does Certara help in drug development?
What is Certara Cloud?
What is the significance of Certara's acquisition of Applied BioMath?
Who are some of Certara's key partners and collaborators?
Where can I find more information about Certara?
