Certara, Inc. Stock Price, News & Analysis

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.

Certara (Nasdaq: CERT), a leader in model-informed drug development, has appointed Dr. Christopher Bouton as Chief Technology Officer. Dr. Bouton, founder and former CEO of Vyasa Analytics (acquired by Certara in 2022), will spearhead the development of a next-generation integrated model-informed drug development platform powered by generative AI and biosimulation technology.

Dr. Bouton's background includes founding Entagen (acquired by Thomson Reuters) and experience as a computational biologist at Pfizer. He has already led the development of several Certara AI-based products, including CoAuthor™, a generative AI solution for regulatory and medical writing.

Certara (NASDAQ: CERT), a global leader in model-informed drug development, has scheduled its Q2 2025 earnings release for August 6th, 2025, after market close. The company will host a conference call at 5:00 PM ET to discuss the financial results.

Investors must pre-register online to participate in the conference call, with registration recommended at least one day in advance. Both a live and archived webcast will be accessible through Certara's investor relations website at ir.certara.com.

Certara (Nasdaq: CERT) has expanded its technology collaboration with Merck to enhance clinical data management capabilities. The expanded partnership includes implementing Certara's Pinnacle 21 software platform for metadata repository and data standards workflow management, building upon their existing regulatory submissions collaboration.

The expansion addresses the growing complexity in clinical trial data management, where Phase III trials now average 3.6 million datapoints, representing a threefold increase over the past decade. The Pinnacle 21 platform aims to streamline data standardization for modern digital trials at scale.

Certara (NASDAQ: CERT) reported strong Q1 2025 financial results with total revenue of $106.0 million, up 10% year-over-year. The company's performance was marked by significant growth in software revenue, which increased 18% to $46.4 million, while services revenue grew 4% to $59.6 million. Net income improved substantially to $4.7 million, compared to a net loss of $4.7 million in Q1 2024.

The company's adjusted EBITDA reached $34.8 million, representing 20% growth from the previous year. Total bookings increased 12% to $118.2 million. Certara reaffirmed its full-year 2025 guidance, projecting revenue between $415-425 million and adjusted EBITDA margin of 30-32%. The company's strong performance was driven by growth in its biosimulation software portfolio and M&A contributions.