Certara's PBPK Model Accepted by FDA for New Drug Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 03 2026
0mins
Should l Buy CERT?
Certara announced its Simcyp Simulator enabled physiologically-based pharmacokinetic, PBPK, modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application for asciminib. PBPK modeling uses virtual biological systems to predict how drugs are absorbed, distributed, metabolized, and eliminated by the body, and is increasingly being applied in place of certain clinical studies where appropriate. The results published in "Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib," highlight the growing impact and business benefits of model-informed drug development approaches for regulatory decision-making.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy CERT?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on CERT
Wall Street analysts forecast CERT stock price to rise
11 Analyst Rating
7 Buy
4 Hold
0 Sell
Moderate Buy
Current: 6.650
Low
9.00
Averages
12.11
High
16.00
Current: 6.650
Low
9.00
Averages
12.11
High
16.00
About CERT
Certara, Inc. is a provider of biosimulation technology and solutions for using Model-Informed Drug Development (MIDD) in the global biopharmaceutical industry. It accelerates medicine using biosimulation software, technology and services to transform traditional drug discovery and development. It delivers software products and technology-driven services to customers to carry out and realize the full benefits of biosimulation in drug discovery, preclinical and clinical research, regulatory submissions and market access. Its regulatory science and market access software and services, such as regulatory submissions software, natural language processing and Bayesian analytics. It offers both mechanistic and empirical biosimulation solutions providing clients with a comprehensive offering based on their therapy goals, mechanism of action, and available data sources. Its clients include 2,400 biopharmaceutical companies, academic institutions and regulatory agencies across 70 countries.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Certara to Participate in Multiple Investor Conferences
- Investor Conference Schedule: Certara will participate in three significant healthcare investor conferences on March 3, 9, and 10, 2026, showcasing its leadership in drug development.
- Timing Details: The TD Cowen conference is set for March 3 at 3:10 PM, the Leerink conference on March 9 at 8:00 AM, and the Barclays conference on March 10 at 1:00 PM, ensuring timely updates for investors.
- Webcast Availability: Each conference will feature live webcasts accessible via Certara's investor relations website, with replays available for at least 90 days post-event, enhancing information accessibility for stakeholders.
- Extensive Client Base: Certara serves over 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries, highlighting its significant influence and demand in the global drug development landscape.
See More
Certara, Inc. Q4 2025 Earnings Call Insights
- Revenue Growth: Certara reported total revenue of $103.6 million for Q4 2025, reflecting a 3% year-over-year increase, demonstrating the company's stability and potential growth opportunities in the life sciences sector despite market challenges.
- Adjusted EBITDA: The adjusted EBITDA for Q4 was $32.5 million, down from $33.5 million in Q4 2024, highlighting the urgency and necessity for the company to enhance operational efficiency.
- Strategic Priorities: New CEO Jon Resnick emphasized three strategic priorities, including focusing on the product portfolio, deepening customer engagement, and raising operational standards, aiming to drive future growth through AI-driven efficiencies.
- Future Outlook: Certara projects total revenue for 2026 to be flat to 4% growth, with management acknowledging that this year will be a transition period, planning to reinvigorate growth and enhance shareholder value through cost control and innovation.
See More
Certara to Announce Q4 Earnings on February 26
- Earnings Announcement Date: Certara is set to release its Q4 earnings on February 26 before market open, with a consensus EPS estimate of $0.10, reflecting a 33.3% year-over-year decline, indicating potential pressure on profitability.
- Revenue Expectations: The anticipated revenue for Q4 is $103.23 million, representing a modest 2.8% year-over-year growth, which, while limited, demonstrates the company's resilience in revenue growth and may help stabilize investor confidence.
- Historical Performance Review: Over the past two years, Certara has beaten EPS estimates 63% of the time and revenue estimates 75% of the time, suggesting a degree of reliability in financial performance that could attract investor interest ahead of the earnings release.
- Management Changes: Certara recently appointed Jon Resnick as the new CEO and reaffirmed its FY25 outlook, a strategic decision that may influence the company's long-term direction and market confidence.
See More
Oversold Stocks in Healthcare Sector Present Buying Opportunities
- Oversold Stocks Overview: In the healthcare sector, Zai Lab Ltd (NASDAQ:ZLAB), Vivos Therapeutics Inc (NASDAQ:VVOS), and Certara Inc (NASDAQ:CERT) are identified as oversold stocks, with RSI near or below 30, indicating potential for short-term rebounds.
- RSI Indicator Analysis: The Relative Strength Index (RSI) serves as a momentum indicator by comparing the strength of a stock on days it rises versus days it falls, helping traders assess short-term performance, with an RSI below 30 typically indicating oversold conditions.
- Investment Opportunity Assessment: In the current market environment, oversold stocks may present buying opportunities for investors looking to capitalize on undervalued companies, particularly in the healthcare sector, where sentiment shifts could lead to value recovery.
- Market Data Source: This information is based on data from Benzinga Pro, providing the latest list of oversold stocks in the healthcare sector to assist investors in identifying potential investment opportunities.
See More
Certara Announces Q4 and Full Year 2025 Financial Results Release
- Earnings Release Schedule: Certara will release its financial results for Q4 and the full year of 2025 before market open on February 26, 2026, providing investors with critical performance data and future outlook.
- Conference Call Details: Company management will host a conference call at 8:30 AM ET to discuss the financial results, requiring investors to register online in advance to ensure timely information dissemination.
- Webcast Availability: The event will feature both live and archived webcasts, accessible through the 'Investors' section of Certara's website, enhancing transparency and ease of information access for stakeholders.
- Broad Client Base: Certara serves over 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries, demonstrating its global influence and market leadership in drug development.
See More
Cerrado Gold Completes Gold Hedge, Shifts to 100% Near-Spot Sales
- Gold Hedge Completion: Cerrado Gold concluded its gold hedging program on January 15, 2026, eliminating the previous ceiling of $3,250/oz, allowing the company to sell gold at near-spot prices, which significantly enhances profitability and free cash flow.
- Share Buyback Initiative: The company has proposed a normal course issuer bid (NCIB) to repurchase up to 6,794,790 common shares, representing approximately 5% of its outstanding shares, aimed at leveraging strong gold prices to increase net asset value per share and enhance shareholder ownership.
- Cash Flow Management: Cerrado Gold plans to utilize excess cash from gold sales above budgeted prices for share buybacks without impacting current growth plans, ensuring a strong cash balance at the end of 2026, thereby providing higher returns to shareholders.
- Project Investment Progress: Following the completion of the gold hedge, the company will continue advancing key investments, including the underground mine and Lagoa Salgada and Mont Sorcier projects, further optimizing asset value and improving overall financial health.
See More
Certara to Participate in Multiple Investor Conferences
- Investor Conference Schedule: Certara will participate in three significant healthcare investor conferences on March 3, 9, and 10, 2026, showcasing its leadership in drug development.
- Timing Details: The TD Cowen conference is set for March 3 at 3:10 PM, the Leerink conference on March 9 at 8:00 AM, and the Barclays conference on March 10 at 1:00 PM, ensuring timely updates for investors.
- Webcast Availability: Each conference will feature live webcasts accessible via Certara's investor relations website, with replays available for at least 90 days post-event, enhancing information accessibility for stakeholders.
- Extensive Client Base: Certara serves over 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries, highlighting its significant influence and demand in the global drug development landscape.
See More
Certara, Inc. Q4 2025 Earnings Call Insights
- Revenue Growth: Certara reported total revenue of $103.6 million for Q4 2025, reflecting a 3% year-over-year increase, demonstrating the company's stability and potential growth opportunities in the life sciences sector despite market challenges.
- Adjusted EBITDA: The adjusted EBITDA for Q4 was $32.5 million, down from $33.5 million in Q4 2024, highlighting the urgency and necessity for the company to enhance operational efficiency.
- Strategic Priorities: New CEO Jon Resnick emphasized three strategic priorities, including focusing on the product portfolio, deepening customer engagement, and raising operational standards, aiming to drive future growth through AI-driven efficiencies.
- Future Outlook: Certara projects total revenue for 2026 to be flat to 4% growth, with management acknowledging that this year will be a transition period, planning to reinvigorate growth and enhance shareholder value through cost control and innovation.
See More
Certara to Announce Q4 Earnings on February 26
- Earnings Announcement Date: Certara is set to release its Q4 earnings on February 26 before market open, with a consensus EPS estimate of $0.10, reflecting a 33.3% year-over-year decline, indicating potential pressure on profitability.
- Revenue Expectations: The anticipated revenue for Q4 is $103.23 million, representing a modest 2.8% year-over-year growth, which, while limited, demonstrates the company's resilience in revenue growth and may help stabilize investor confidence.
- Historical Performance Review: Over the past two years, Certara has beaten EPS estimates 63% of the time and revenue estimates 75% of the time, suggesting a degree of reliability in financial performance that could attract investor interest ahead of the earnings release.
- Management Changes: Certara recently appointed Jon Resnick as the new CEO and reaffirmed its FY25 outlook, a strategic decision that may influence the company's long-term direction and market confidence.
See More
Oversold Stocks in Healthcare Sector Present Buying Opportunities
- Oversold Stocks Overview: In the healthcare sector, Zai Lab Ltd (NASDAQ:ZLAB), Vivos Therapeutics Inc (NASDAQ:VVOS), and Certara Inc (NASDAQ:CERT) are identified as oversold stocks, with RSI near or below 30, indicating potential for short-term rebounds.
- RSI Indicator Analysis: The Relative Strength Index (RSI) serves as a momentum indicator by comparing the strength of a stock on days it rises versus days it falls, helping traders assess short-term performance, with an RSI below 30 typically indicating oversold conditions.
- Investment Opportunity Assessment: In the current market environment, oversold stocks may present buying opportunities for investors looking to capitalize on undervalued companies, particularly in the healthcare sector, where sentiment shifts could lead to value recovery.
- Market Data Source: This information is based on data from Benzinga Pro, providing the latest list of oversold stocks in the healthcare sector to assist investors in identifying potential investment opportunities.
See More
Certara Announces Q4 and Full Year 2025 Financial Results Release
- Earnings Release Schedule: Certara will release its financial results for Q4 and the full year of 2025 before market open on February 26, 2026, providing investors with critical performance data and future outlook.
- Conference Call Details: Company management will host a conference call at 8:30 AM ET to discuss the financial results, requiring investors to register online in advance to ensure timely information dissemination.
- Webcast Availability: The event will feature both live and archived webcasts, accessible through the 'Investors' section of Certara's website, enhancing transparency and ease of information access for stakeholders.
- Broad Client Base: Certara serves over 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries, demonstrating its global influence and market leadership in drug development.
See More
Cerrado Gold Completes Gold Hedge, Shifts to 100% Near-Spot Sales
- Gold Hedge Completion: Cerrado Gold concluded its gold hedging program on January 15, 2026, eliminating the previous ceiling of $3,250/oz, allowing the company to sell gold at near-spot prices, which significantly enhances profitability and free cash flow.
- Share Buyback Initiative: The company has proposed a normal course issuer bid (NCIB) to repurchase up to 6,794,790 common shares, representing approximately 5% of its outstanding shares, aimed at leveraging strong gold prices to increase net asset value per share and enhance shareholder ownership.
- Cash Flow Management: Cerrado Gold plans to utilize excess cash from gold sales above budgeted prices for share buybacks without impacting current growth plans, ensuring a strong cash balance at the end of 2026, thereby providing higher returns to shareholders.
- Project Investment Progress: Following the completion of the gold hedge, the company will continue advancing key investments, including the underground mine and Lagoa Salgada and Mont Sorcier projects, further optimizing asset value and improving overall financial health.
See More
