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) reported third quarter 2025 results: revenue $104.6M (+10% YoY), software revenue $43.8M (+22% YoY; organic software +6%), and services revenue $60.8M (+3% YoY). Net income was $1.5M versus a $1.4M loss a year earlier; diluted EPS was $0.01. Adjusted EBITDA was $35.2M (+7% YoY) and adjusted net income was $22.2M (+$2.0M YoY). Bookings totaled $96.6M (+1% YoY) with software bookings $40.8M (+17%) and services bookings $55.8M (−9%).
The company narrowed and raised full-year 2025 guidance to $415M–$420M revenue, target ~32% adjusted EBITDA margin, and $0.45–$0.47 adjusted diluted EPS with fully diluted shares of 160M–162M.
Certara (NASDAQ: CERT) launched TFL Studio, the first cloud-native module of its Phoenix Cloud platform, on November 4, 2025. TFL Studio is a no-code environment for creating tables, figures, and listings (TFLs) used in regulatory submissions and publications, and it integrates with Integral, Certara’s data repository.
Certara says TFL Studio can deliver TFLs up to 50% faster. A complementary module, AI PK Reports powered by CoAuthor, will be released this quarter and aims to cut PK report drafting from days to minutes.
Certara (Nasdaq: CERT) said company management will participate in three investor conferences in November 2025 and that live webcasts and replays will be available on the company investor relations website.
- UBS Global Healthcare Conference — Tuesday, November 11, 2025 at 2:00 PM ET
- Jefferies Global Healthcare Conference (London) — Tuesday, November 18, 2025 at 10:30 AM GMT
- Stephens Annual Investment Conference — Tuesday, November 18, 2025 at 1:00 PM CT
Live webcasts will stream at https://ir.certara.com and replays will be available for at least 90 days after each event.
Certara (Nasdaq: CERT) launched Certara IQ on October 30, 2025, an AI-powered Quantitative Systems Pharmacology (QSP) platform designed to scale biosimulation across drug discovery and development.
The platform combines generative-AI, a library of pre-built scientifically validated QSP models and templates, a no-code “what-if” interface, and a high-performance simulation engine that the company says runs simulations thousands of times faster than traditional tools.
Certara IQ aims to improve model reproducibility, reduce manual work, shorten simulation times, and support dosing and patient-population decision making.
Certara (Nasdaq: CERT) highlighted scientific impact on Oct 20, 2025 after publishing >200 papers in the past year and placing 11 Certara scientists on the 2025 Stanford/Elsevier top 2% most‑cited researchers list.
The release notes the company’s longstanding leadership in pharmacology and pharmacokinetics, the Simcyp Simulator’s use by more than 11 global regulatory agencies and support for over 120 FDA‑approved drugs, the Simcyp Consortium’s 35 member companies, and recognition of Amin Rostami‑Hodjegan with the 2025 Lewis B. Sheiner Lecturer Award.
Certara (Nasdaq: CERT) will release third quarter 2025 financial results after market close on November 6, 2025. Management will host a conference call to discuss the results at 5:00 PM ET the same day. Investors must register online to listen and are recommended to register at least one day in advance. A live and archived webcast will be available in the Investors section of Certara's website at https://ir.certara.com/.
Certara (Nasdaq: CERT) has launched Pinnacle 21 Enterprise Plus, a new solution designed to streamline the creation and management of CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets for regulatory submissions. The platform features a no-code interface that delivers a 50% reduction in specification drafting time compared to traditional methods.
The solution addresses key challenges in data management by providing a unified workspace that improves collaboration and version control. Trusted by over 130 organizations globally, including the US FDA and Japan's PMDA, Pinnacle 21 Enterprise Plus offers configurable standards compliance, API integration with programming tools, and accelerated submission cycle times.
Certara (Nasdaq: CERT), a global leader in model-informed drug development, has announced its participation in two upcoming investor conferences in September 2025.
Management will present at the Baird Global Healthcare Conference on Tuesday, September 9 at 10:15 a.m. ET, followed by the Morgan Stanley 23rd Annual Global Healthcare Conference on Wednesday, September 10 at 12:20 p.m. ET. Both presentations will be available via webcast on Certara's investor relations website with replay access for 90 days.
Certara (Nasdaq: CERT), a leader in model-informed drug development, reported strong Q2 2025 financial results with total revenue of $104.6 million, up 12% year-over-year. The company demonstrated significant growth across segments, with software revenue increasing 22% to $46.7 million and service revenue growing 5% to $57.9 million.
The company's net loss improved substantially to $2.0 million from $12.6 million in Q2 2024, while Adjusted EBITDA grew 21% to $31.9 million. Total bookings reached $112.0 million, representing 13% year-over-year growth. Certara maintained its full-year 2025 guidance, projecting revenue between $415-425 million and adjusted EBITDA margin of 30-32%.
Certara (NYSE:CERT) has achieved a significant regulatory milestone as its Simcyp® Simulator becomes the first and only software platform to receive European Medicines Agency (EMA) qualification for PBPK modeling in regulatory submissions across the EU.
The qualification, following a multi-year collaboration with EMA, enables pharmaceutical companies to use Simcyp Simulator for assessing drug-drug interaction (DDI) risk in regulatory submissions without re-establishing the platform's credibility. The qualification covers 3 context-of-use scenarios spanning 6 CYP enzymes and 2 inhibition mechanisms, potentially reducing the number of required clinical studies.
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