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 (Nasdaq: CERT), a global leader in model-informed drug development, has announced its participation in the Stephens Annual Investment Conference. The company's management will deliver a presentation on Thursday, November 21st, 2024, at 10:00 AM CT. Investors and interested parties can access a live webcast of the presentation through Certara's investor relations website at https://ir.certara.com. The presentation recording will remain available for replay for a minimum of 90 days following the event.
Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, has appointed John Reynders, PhD, to its Board of Directors, effective October 15, 2024. Dr. Reynders brings over 25 years of experience in the pharmaceutical and tech industries, with expertise in artificial intelligence, data science, and life science.
Dr. Reynders' career highlights include serving as the founding CIO of Moderna, where he led data-sciences capabilities for mRNA therapy design, and as Chief Data Sciences Officer at Neumora. He has also held executive positions at Alexion Pharmaceuticals, AstraZeneca, Johnson & Johnson, Eli Lilly, and Celera.
Certara's CEO, William F. Feehery, PhD, expressed excitement about the appointment, emphasizing the value Dr. Reynders' expertise will bring to the company's ongoing development of transformational software and services for accelerating new medicines and increasing pharma R&D productivity.
Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, has announced it will release its financial results for the third quarter of 2024 after the market close on Wednesday, November 6th, 2024. The company management will host a conference call to discuss the financial results at 5:00PM ET. Investors interested in participating in the conference call are required to register online, with registration recommended at least one day in advance. A live and archived webcast of the event will be available on the "Investors" section of Certara's website at https://ir.certara.com/.
Certara, Inc. (Nasdaq: CERT), a leader in model-informed drug development, has completed the acquisition of Chemaxon, a developer of scientific informatics software for in-silico research in the life sciences industry. The combined organization aims to offer improved predictive biosimulation and scientific informatics capabilities to enhance decision-making from discovery through commercialization.
Key points:
- Integration plans include incorporating Chemaxon's chemistry structures, calculators, and predictors into Certara's D360 applications and Simcyp™ PBPK Simulator.
- Long-term plans involve leveraging Certara.AI's specialized GPT capabilities and expanding pharmacokinetics and pharmacodynamics knowledge in drug discovery processes.
- Chemaxon is expected to generate software revenue exceeding $20 million in 2024.
- Certara will update its 2024 guidance to include Chemaxon's contribution in its third-quarter earnings report in November.
Certara (Nasdaq: CERT) celebrates the 25th anniversary of its Simcyp Consortium, a pre-competitive scientific research group comprising 35 leading biopharmaceutical companies. The consortium has become a global authority on physiologically-based pharmacokinetic (PBPK) modeling and simulation.
The Simcyp Simulator, used by pharmaceutical companies, academia, and regulatory agencies, has informed dosing decisions for over 375 label claims across 115+ drugs. It accurately predicts drug behavior in the human body, aiding various stages of drug development.
The consortium has awarded grants totaling $1.4 million to support 13 PhD and postdoctoral researchers. Simcyp provides academic licenses to more than 110 universities worldwide, and its publications have been cited over 8,000 times in scientific literature.
Certara (Nasdaq: CERT) and Ichnos Glenmark Innovation (IGI) collaborated on optimizing the first-in-human dosing strategy for ISB 2001, a trispecific T-cell engager for cancer treatment. The research, published in Nature Cancer, used virtual trials to select a higher starting dose, increasing it by 50-100 fold over conventional methods. This approach, approved by the FDA and Australian HREC, aims to reduce costs, minimize ineffective dosing, and accelerate drug development.
The collaboration leveraged Certara's expertise in quantitative systems pharmacology and physiologically-based pharmacokinetics to develop a virtual clinical trial platform. This innovative method not only enhances patient safety and efficacy but also aligns with regulatory goals to reduce animal studies. The optimized dosing strategy for ISB 2001 showcases the potential of virtual patient technology in drug development, particularly for complex biologics like T-cell engagers.
Certara (Nasdaq: CERT), a leader in model-informed drug development, has announced its participation in two upcoming investor conferences. The company will be present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 at 4:05 p.m. ET and the Baird Global Healthcare Conference on September 11 at 10:15 a.m. ET.
Both conference presentations will be available via live webcasts on Certara's investor relations website at https://ir.certara.com. These webcasts will remain accessible for replay for at least 90 days after the events. This participation provides investors with opportunities to gain insights into Certara's operations and future prospects directly from the company's management.
Certara (Nasdaq: CERT) has launched Phoenix™ version 8.5, an upgraded drug development software used by top pharmaceutical companies and regulatory agencies worldwide. This release aims to improve the efficiency, quality, and speed of pharmacokinetic/pharmacodynamic (PK/PD) workflows. Key features include:
1. Sign-in via Certara Cloud for simplified license management and enhanced access control
2. Reporting enhancements for better data presentation and analysis
3. NLME improvements for more precise modeling and interpretation
Phoenix 8.5 was developed based on customer feedback to streamline drug development processes and potentially reduce the high failure rate of new medicines in clinical trials. The software is available as a hosted solution for improved performance and cost-effectiveness.
Certara (Nasdaq: CERT) reported its Q2 2024 financial results, showing mixed performance. Revenue increased 3% year-over-year to $93.3 million, driven by 13% growth in software revenue to $38.2 million. However, services revenue declined 3% to $55.1 million. The company reported a net loss of $12.6 million, compared to a net income of $4.7 million in Q2 2023. Adjusted EBITDA decreased to $26.3 million from $32.4 million last year.
Despite challenges in services due to cautious spending among large biopharma customers, Certara reiterated its full-year 2024 guidance. The company expects revenue between $385-400 million, adjusted EBITDA margin of 31-33%, and adjusted diluted EPS of $0.41-$0.46.
Certara, a leader in model-informed drug development, has signed a definitive agreement to acquire cheminformatics software provider Chemaxon. The acquisition is expected to close in the second half of 2024, pending regulatory approvals. This deal aims to enhance Certara's drug discovery capabilities by integrating Chemaxon's software, which is important for chemical structure drawing, property prediction, and analysis.
Chemaxon is projected to generate over $20 million in software revenue in 2024 and is expected to align with Certara’s EBITDA margin by the end of 2025. The combined entity will offer a comprehensive data and predictive analytics platform, expected to improve decision-making and reduce costs in drug development.
Certara has reiterated its full-year 2024 financial outlook, excluding Chemaxon, and will update its guidance post-transaction, maintaining an adjusted EBITDA margin of 31-33%.
