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) delivers biosimulation solutions and model-informed drug development services that accelerate pharmaceutical innovation. This page provides comprehensive coverage of Certara's latest news, including regulatory milestones, strategic partnerships, and advancements in simulation technology.
Investors and industry professionals will find timely updates on earnings reports, product launches, and scientific developments shaping the drug development landscape. Our curated collection features press releases on regulatory submissions, technology platform enhancements, and collaborations with biopharma leaders.
Key focus areas include Certara's biosimulation software updates, regulatory science achievements, and innovations in quantitative pharmacology. Bookmark this page to stay informed about developments impacting clinical trial optimization and global drug approval processes.
Certara, Inc. (Nasdaq: CERT) will announce its second quarter 2021 financial results on August 5, 2021, post-market. A conference call with management is scheduled for 5:00 p.m. ET to discuss these results. Investors can join by dialing (833) 360-0946 domestically or (914) 987-7661 internationally, using Conference ID: 2728807. An archived webcast will also be available on the Certara website. Certara specializes in biosimulation technology, assisting over 1,650 clients, which include biopharmaceutical companies and regulatory agencies worldwide.
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.