RADNOR, Pa., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced that it will release financial results for the fourth quarter and full year of 2025 before market open on Thursday, February 26th, 2026. Company management will host a conference call to discuss financial results at 8:30AM ET. Investors interested in listening to the conference call are required to register online. It is recommended to register at least one day in ...

Summary of Simulations Plus Investor Day - January 21, 2026 Company Overview - **Company**: Simulations Plus (NasdaqGS:SLP) - **Industry**: Biopharmaceutical modeling and simulation - **Focus**: Drug development, commercialization, and scientific consulting Core Points and Arguments Industry Transformation - The biopharma industry is undergoing significant changes, including: - Adoption of AI - Shift towards cloud-native scientific computation - Move away from animal testing - Increased reliance on model-informed drug development [2][12][50] Company Vision and Mission - **Vision**: Improve quality of life through innovative solutions - **Mission**: Create value for clients by accelerating the discovery, development, and commercialization of pharmaceuticals through science-based software and consulting solutions [3][2] Unique Value Proposition - Simulations Plus differentiates itself through: - A combination of scientific excellence and technological innovation - A robust suite of software products including GastroPlus, MonolixSuite, ADMET Predictor, DILIsym, and Thileys [4][5] - The company is evolving from point solutions to an integrated cloud-enabled ecosystem [5] Market Opportunity - Total Addressable Market (TAM) is approximately $12.5 billion: - $4 billion in traditional biosimulation - $8.5 billion in clinical trial training and medical communications [6] Client Needs and Industry Pressures - Clients face pressures from: - Economic factors increasing the cost and complexity of drug development - Scientific complexity requiring advanced modeling techniques - Technological expectations for integrated digital infrastructure [10][11][12] Regulatory Environment - Regulatory agencies are pushing for broader use of model-informed drug development and non-animal methodologies, which aligns with Simulations Plus's offerings [12][56] Strategic Shift - The company is transitioning from a tool provider to an ecosystem partner, focusing on integrated workflows and AI-assisted solutions [14][28] Additional Important Insights Product Strategy and Roadmap - The company is building a unified AI-orchestrated ecosystem that connects various aspects of drug development [20][25] - The architecture includes: - Validated modeling engines - Composition layer for data standardization - Grounded intelligence layer with AI copilots - Orchestration layer for automating workflows [21][22][24] Services and Consulting - Simulations Plus's services complement its product offerings by providing scientific consulting that informs software enhancements and optimizes workflows [33][34] - The consulting teams help clients navigate complex drug development decisions, reducing uncertainty and costs [34][35] Case Studies - Case studies illustrate the effectiveness of Simulations Plus's approach in reducing development timelines and costs while improving clinical trial success rates [41][43] Future Growth and Revenue Opportunities - The acquisition of Pro-ficiency has doubled the TAM and is expected to contribute to future growth [54][55] - The company anticipates increased demand for simulation and modeling services driven by FDA's NAMs guidance [56][58] Pricing Evolution - The company is evolving its pricing strategy to reflect the added value of its integrated ecosystem, with new monetization opportunities expected as the ecosystem matures [29][30] Conclusion - Simulations Plus is well-positioned to lead in the evolving landscape of model-informed drug development, leveraging its scientific expertise, technological innovations, and strategic partnerships to create a cohesive platform that meets the industry's growing demands [53]

Core Insights - Certara, Inc. has appointed Jon Resnick as the new CEO effective January 1, 2026, succeeding William Feehery, who will transition to an advisory role [1][3] - The company reaffirms its financial outlook for the full year 2025 as previously disclosed [4] Leadership Transition - Jon Resnick brings over 20 years of experience from IQVIA, where he held various leadership roles, including President of the U.S. and Canada regional business [2][3] - William Feehery has been credited with guiding Certara through its successful IPO and reinforcing its position as a global leader in biosimulation [4] Company Strategy and Vision - Resnick expressed enthusiasm about leading Certara, emphasizing the company's unique position in drug discovery and development through AI, data, and simulation technologies [3] - The company serves over 2,400 clients, including biopharmaceutical companies and regulatory agencies across 70 countries, highlighting its extensive market reach [5]

Core Viewpoint - Certara, Inc. will release its financial results for Q2 2025 on August 6, 2025, after market close, followed by a conference call at 5:00 PM ET to discuss the results [1]. Company Overview - Certara is a global leader in model-informed drug development, utilizing biosimulation software, technology, and services to enhance traditional drug discovery and development [3]. - The company serves over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [3]. Investor Information - Investors interested in the conference call must register online, with a recommendation to do so at least one day in advance [1]. - A live and archived webcast of the conference call will be available on the "Investors" section of Certara's website [2]. Contact Information - Investor Relations contact is David Deuchler from Gilmartin Group [4]. - Media contact is Alyssa Horowitz [4].

Core Insights - Certara, Inc. has launched the Non-Animal Navigator™ solution to assist biopharmaceutical companies in adapting to the FDA's Roadmap aimed at reducing animal testing in preclinical safety studies, marking a significant shift in drug development practices [1][3] Group 1: Company Overview - Certara is a global leader in model-informed drug development, providing biosimulation software and services to enhance drug discovery and development processes [5] - The company has over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [5] Group 2: Industry Context - The FDA's Roadmap is a pivotal moment for the industry, encouraging the adoption of model-informed drug development approaches that are predictive, efficient, and ethical [3] - Monoclonal antibodies and antibody-drug conjugates (ADCs) are in the preclinical phase across various therapeutic areas, with biosimulation models showing predictive capabilities comparable to traditional animal studies [2] Group 3: Product Features - The Non-Animal Navigator offers strategic regulatory advice to design preclinical programs that align with regulatory requirements and utilize new approach methodologies (NAMs) [5] - It includes an integrated preclinical development plan that combines various evidence types, including in vitro, in vivo, and biosimulation data, supported by expert toxicology input [5] - The solution provides access to advanced AI-enabled modeling tools, such as the Simcyp Simulator, to accelerate development timelines [5]