Certara D360 26.0 Boosts Peptide Drug Discovery Efficiency
Certara has released D360 version 26.0, enhancing peptide drug discovery with improved sequence alignment and design capabilities. The new features include a design sandbox for creating virtual seque...nces and enhanced support for branched peptides. These updates aim to improve the efficiency of drug development by allowing scientists to analyze sequence-activity relationships and design peptides with better biological profiles.
Certara Simcyp Simulator Results Replace Ten Human Trials for Ch
Certara's Simcyp Simulator has been used to replace ten human trials for the Chronic Myeloid Leukemia therapy, asciminib. The U.S. FDA accepted physiologically-based pharmacokinetic modeling predicti...ons from the simulator, aiding the new drug application. This approach enhances drug development efficiency by simulating drug interactions and dosing regimens, supporting regulatory approval.
Certara Inc Announces Simcyp Simulator Results Replace Ten Human Trials ...
Certara Inc. announced that its Simcyp Simulator's physiologically-based pharmacokinetic (PBPK) modeling results have been accepted by the U.S. FDA to replace ten human trials for the drug asciminib,... used in treating Chronic Myeloid Leukemia. This innovative approach supports the new drug application by predicting drug interactions and pharmacokinetics, enhancing regulatory decision-making and potentially expediting drug approval processes.
Certara Simcyp Simulator Results Replace Ten Human Trials for Chronic Myeloid Leukemia (CML) Therapy asciminib
Certara's Simcyp Simulator has successfully replaced ten human trials for the Chronic Myeloid Leukemia therapy, asciminib, using physiologically-based pharmacokinetic modeling. This model-informed ap...proach, accepted by the U.S. FDA, supports the new drug application by predicting drug interactions and optimal dosing. The collaboration with Novartis highlights the simulator's role in regulatory decision-making and drug development.
Certara has launched the DIDB Concomitant Meds Navigator, a new software tool designed to identify contraindicated concomitant medications during drug studies. This tool, part of Certara's Drug Inter...action Database, helps research teams make informed decisions to protect study participants. It extends Certara's leadership in drug interaction science by providing comprehensive, up-to-date data on drug interactions, including investigational drugs and natural products.
Certara Launches Pinnacle 21 Enterprise Plus | Press Release
Certara has launched Pinnacle 21 Enterprise Plus, a solution designed to expedite regulatory submissions by reducing the time spent on drafting mapping specifications by 50%. This platform supports i...ndustry and proprietary standards, integrates seamlessly with tools like SAS and R, and aims to streamline the creation of submission-ready datasets, enhancing efficiency for clinical and statistical programmers.
Certara has released D360 version 25.5, enhancing data visualization and analytics for drug development. Key updates include dynamic data subsets, improved sequence-based modality support, and small ...molecule analysis capabilities. The release also introduces API changes, requiring a switch to Service Tokens for authentication.
Certara's Simcyp Simulator Achieves EMA Qualification for Regulatory ...
Certara's Simcyp Simulator has received EMA qualification for regulatory submissions in the EU, marking it as the first PBPK modeling platform to achieve this status. This qualification allows drug d...evelopers to assess drug-drug interaction risks more efficiently, streamlining the submission process and reducing the need for extensive clinical studies. Certara's leadership in biosimulation is reinforced, enhancing its reputation in the biopharmaceutical sector.
Certara Simcyp Simulator Becomes First and Only Software Platform to ...
Certara's Simcyp Simulator has become the first software platform to receive EMA qualification for PBPK modeling, allowing its use in regulatory submissions across the EU. This qualification simplifi...es the drug submission process by reducing the need for clinical DDI studies, highlighting Certara's leadership in biosimulation and innovation in model-informed drug development.
New Integral Data Repository has Powerful REST API capabilities
Certara has introduced the Integral Data Repository featuring robust REST API capabilities. This new solution enables seamless integration, advanced data access, and automation for drug development w...orkflows. The repository supports interoperability with other platforms, streamlining regulatory submissions and enhancing data-driven decision-making in pharmaceutical R&D.
Altasciences and Certara Announce Strategic Partnership to Accelerate ...
Certara and Altasciences have formed a strategic partnership to enhance early-phase drug development. By integrating Certara's biosimulation technology with Altasciences' Acceleration Platform, the c...ollaboration aims to improve study designs, refine dosing strategies, and enable faster, informed decision-making. This model-first approach supports adaptive, data-driven drug development, aligning with FDA guidance and benefiting biotech sponsors and patients globally.
Thieme integrates Certara Chemaxons new generation chemical sketcher, Marvin, into its chemical databases Science of Synthesis and Pharmaceutical Substances
Certara's Chemaxon has integrated its latest version of Marvin, a chemical sketcher, into Thieme's chemical databases, Science of Synthesis and Pharmaceutical Substances. This integration enhances th...e accuracy and user-friendliness of chemical structure drawing, streamlining tasks for chemists and improving synthesis planning. The integration required minimal development effort, demonstrating Marvin's ease of use and adaptability.
Certara Partners with Veeva AI to Automate Regulatory Submissions
Certara has partnered with Veeva AI to integrate Certaras CoAuthor generative AI solution with Veeva RIM, enhancing regulatory submissions for life sciences. This collaboration automates document cre...ation, streamlines data flows, and improves collaboration between data providers and regulatory writers, reducing preparation time by 30%. The integration allows seamless access to source files, expediting submission processes and improving accuracy.
Certara Announces Expansion of Clinical Technology Collaboration with Merck - TradingView
Certara has expanded its clinical technology collaboration with Merck, enhancing Merck's use of Certara's Pinnacle 21 software platform. This expansion includes a metadata repository and data standar...ds workflow management, aiming to streamline regulatory submissions and manage data standards in clinical trials.
Certara Announces Expansion of Clinical Technology ... - Morningstar
Certara expands its collaboration with Merck to enhance the use of its Pinnacle 21 software platform, incorporating a metadata repository and data standards workflow management. This collaboration ai...ms to streamline data standardization in clinical trials, addressing the growing complexity of drug development data.
Veristat acquires Certara regulatory and medical writing business
Veristat has agreed to acquire Certara's regulatory and medical writing business, enhancing its clinical development capabilities. The acquisition will add over 200 specialists to Veristat, strengthe...ning its support for regulatory submissions in complex therapeutic areas. The deal, backed by WindRose Health Investors, is expected to close in Q2 2026.
Veristat to Acquire Certara Unit to Expand CRO Regulatory Capabilities
Veristat has entered a definitive agreement to acquire Certara's Regulatory and Medical Writing business for up to $135 million. This acquisition will add over 200 professionals to Veristat's platfor...m, enhancing its regulatory strategy and medical writing capabilities. The deal, expected to close in Q2 2026, aims to streamline operations and support complex therapy submissions, reflecting consolidation trends in the CRO market.
Veristat to Acquire Certaras Regulatory and Medical Writing Business
Veristat plans to acquire Certara's Regulatory and Medical Writing business, enhancing its capabilities with over 200 experts. This acquisition, supported by WindRose Health Investors, aims to streng...then Veristat's position in regulatory affairs and medical writing. The transaction is expected to close in Q2 2026.
Veristat to Acquire Certara's Regulatory and Medical Writing Business
Veristat plans to acquire Certara's Regulatory and Medical Writing business, enhancing its regulatory services with over 200 experts. This strategic move, supported by WindRose Health Investors, aims... to strengthen Veristat's capabilities in biostatistics, medical writing, and regulatory affairs, facilitating faster delivery of life-saving therapies. The acquisition is expected to close in Q2 2026.
Certara Enters Definitive Agreement for the Sale of its Regulatory and ...
Certara has entered a definitive agreement to sell its Regulatory and Medical Writing business to Veristat for up to $135 million. The sale aligns with Certara's focus on expanding its Model-Informed... Drug Development (MIDD) and Clinical Intelligence solutions. The transaction is expected to close in Q2 2026, and Certara plans to update its 2026 guidance post-closure.
Certara stock (US1567671046): Q1 revenue up 1% but services decline sparks investigation
Certara reported a 1% increase in Q1 2026 revenue to $106.9 million, despite a 4% decline in services revenue. This led to a securities fraud investigation by Kirby McInerney LLP. The company's core ...biosimulation software remains crucial for drug development, supporting major pharma firms like Pfizer and Moderna.
Certara Reports First Quarter 2026 Financial Results
Certara reported its Q1 2026 financial results, showing a 1% revenue increase to $106.9 million. Software revenue rose 7% to $49.7 million, while services revenue decreased by 4% to $57.2 million. Th...e company posted a net loss of $8.8 million, compared to a net income of $4.7 million the previous year. Certara completed the sale of its medical writing business to Veristat for up to $135 million.
Certara Q1 2026 results: sells medical writing unit for $85M
Certara reported Q1 2026 revenue of $106.9 million, with software revenue up 7% and services revenue down 4%. The company sold its medical writing unit to Veristat for $85 million, aiming to focus on... drug development. Certara updated its 2026 revenue guidance to $395-$405 million.
Certara to Report First Quarter 2026 Financial Results on May 11th ...
Certara will announce its first quarter 2026 financial results on May 11, 2026, before the market opens. A conference call to discuss these results will be held at 8:30 AM ET.
Certara reported 2025 organic software revenue growth of 7% and an adjusted EBITDA margin of 32%, despite a decline in Q4 software bookings. The company launched three new software offerings: Certara... IQ for QSP, Phoenix Cloud, and a Pinnacle enhancement. These launches are expected to drive growth in 2026. Certara also highlighted its AI strategy and potential changes in its regulatory services segment.
Certara's 2025 Results Highlight Software Strength and Service...
Certara reported a 9% revenue increase in 2025, driven by an 18% rise in biosimulation software revenue. Despite a net loss, adjusted EBITDA grew 10% to $134.5 million. Service bookings surged 17%, o...ffsetting a dip in software bookings. The company anticipates flat to 4% revenue growth in 2026, focusing on innovation and strategic execution under new CEO Jon Resnick.
Certara Reports Fourth Quarter 2025 Financial Results; Provides Full Year 2026 Guidance
Certara reported its Q4 2025 financial results, with a revenue of $103.6 million, marking a 3% year-over-year growth. The company also provided its full-year 2026 guidance, anticipating revenue growt...h of 0-4% and an adjusted EBITDA margin of 30-32%. Certara's software revenue grew by 10%, driven by biosimulation software, while services revenue slightly decreased by 1%.
Certara to Report Fourth Quarter and Full Year 2025 Financial Results on February 26th, 2025 - The Manila Times
Certara will announce its fourth quarter and full year 2025 financial results on February 26, 2026, before the market opens. A conference call to discuss the results will follow at 8:30 AM ET.
Certara to Report Fourth Quarter and Full Year 2025 Financial Results on February 26th, 2025 - marketscreener.com
Certara, Inc. will announce its fourth quarter and full year 2025 financial results on February 26, 2026. The company will host a conference call to discuss these results, with a live and archived we...bcast available on its website.
Certara to Report Second Quarter 2025 Financial Results on August 6th, 2025 - TradingView
Certara will announce its second quarter 2025 financial results on August 6th, 2025, after market close. A conference call to discuss the results will follow at 5:00 PM ET.
Certara Reports Second Quarter 2025 Financial Results
Certara reported its financial results for Q2 2025, showing a 12% revenue increase to $104.6 million. Software revenue grew by 22%, while services revenue rose by 5%. The company reduced its net loss... to $2 million from $12.6 million in Q2 2024. Certara reiterated its full-year financial guidance, highlighting strong performance in biosimulation software and services.
Certara to Report Second Quarter 2025 Financial Results on August 6th ...
Certara will announce its second-quarter 2025 financial results on August 6th, 2025, after market close. A conference call will follow at 5:00 PM ET, with a live and archived webcast available on Cer...tara's investor relations website.
Certara, Inc. to Release Second Quarter 2025 Financial Results on August 6th - Quiver Quantitative
Certara, Inc. will announce its second-quarter 2025 financial results on August 6, 2025, with a conference call scheduled for 5:00 PM ET. The call will be accessible via a live and archived webcast o...n Certara's website.
Certara Appoints Dr. Britta Wagenhuber as Head of Quantitative Systems Pharmacology (QSP) Consultancy
Certara has appointed Dr. Britta Wagenhuber as Head of Quantitative Systems Pharmacology Consultancy. With over 14 years of experience in mechanistic model-informed drug development, she will enhance... Certara's AI-enabled QSP capabilities. Her role aims to accelerate drug development by improving decision-making processes and delivering innovative medicines to patients.
Certara, Inc. Appoints Jon Resnick as CEO, Succeeding William Feehery, Effective January 1, 2026 - Quiver Quantitative
Certara, Inc. has appointed Jon Resnick as CEO, effective January 1, 2026, succeeding William Feehery. Resnick, with over 20 years of experience at IQVIA, is expected to drive growth and innovation i...n drug development. Feehery will remain as an external advisor during the transition. The company reaffirms its 2025 financial outlook.
Certara Appoints Jon Resnick as Chief Executive Officer - The Manila Times
Certara appointed Jon Resnick as CEO, effective January 1, 2026, succeeding William Feehery. Resnick, with over 20 years at IQVIA, brings extensive leadership experience in health sciences and busine...ss operations. Certara reaffirms its 2025 financial outlook and highlights its focus on advancing model-informed drug development.
Certara Appoints Dr. Chris Bouton as Chief Technology Officer to ...
Certara has appointed Dr. Chris Bouton as Chief Technology Officer to enhance its AI-driven in-silico drug discovery platform. Bouton, previously CEO of Vyasa Analytics, will lead the development of ...Certara's next-generation model-informed drug development platform, integrating AI and biosimulation to improve drug discovery efficiency. His leadership aims to accelerate the adoption of AI-powered biosimulation, aiding faster and more successful drug development.
Certara, Inc. Appoints Christopher Bouton, Ph.D., as Chief Technology ...
Certara, Inc. has appointed Christopher Bouton, Ph.D., as Chief Technology Officer to lead the development of a next-generation drug development platform. Bouton, who has a strong background in AI an...d drug development, will focus on integrating generative AI and biosimulation to enhance drug discovery processes. His leadership aims to improve the efficiency and success rates of therapeutic discoveries.
Awards, Recognitions, and Industry Achievements of Certara GlobalSubmit eCTD software
Certara Wins Great Place to Work Certification for 4th Year
Certara has earned the Great Place to Work Certification for the fourth consecutive year, recognizing its positive workplace culture and employee experience in the drug development technology sector.
