Certara, Inc. Stock Price, News & Analysis

Certara (Nasdaq: CERT) has secured a five-year contract from the FDA for its Pinnacle 21 Enterprise software, which enhances the agency's ability to review clinical and non-clinical study submission data. This agreement continues a long-standing partnership and follows previous contracts awarded in 2011 and 2015. The software streamlines data validation processes, allowing FDA reviewers to assess data quality more efficiently. This contract also supports the FDA’s DataFit program amid new technical rejection criteria implementation.

Certara, Inc. (Nasdaq: CERT) will release its third-quarter 2021 financial results on November 9, 2021, post-market. A conference call with management to discuss these results will occur at 5:00 p.m. ET. Interested investors can join the call by dialing (833) 360-0946 for domestic and (914) 987-7661 for international participants, using Conference ID: 1968232. The event will also be available via a live and archived webcast on Certara's Investors webpage.

Certara specializes in biosimulation software and technology, assisting over 1,650 clients globally.

Certara, Inc. (Nasdaq: CERT) has appointed Patrick F. Smith, Pharm.D., as the new president of Integrated Drug Development (IDD). He succeeds Craig R. Rayner, Pharm.D., who will transition to a role as a distinguished scientist. Dr. Smith brings extensive experience in drug development, particularly in infectious diseases and oncology, having previously served as senior vice president of IDD strategy and innovation. His leadership aims to enhance Certara's biosimulation and quantitative approaches across the drug development life cycle, positioning the company for continued growth.

Certara Appoints New Chief Commercial Officer

On October 5, 2021, Certara (Nasdaq: CERT) announced the appointment of Drayton T. Virkler as Chief Commercial Officer. With over 20 years of experience in the pharma sector, Virkler's role focuses on enhancing global commercial strategies and business development. Previously at IQVIA, he led sales and marketing, achieving annual revenue growth. Virkler aims to broaden Certara’s reach in biosimulation technologies, ultimately improving drug development processes for clients worldwide.

Certara has successfully acquired Pinnacle 21 for approximately $250 million in cash and 2.24 million shares of restricted common stock. This strategic acquisition aims to enhance Certara's capabilities in clinical data management and regulatory compliance, crucial for expediting drug development. Pinnacle 21's software is already adopted by leading biopharmaceutical companies and regulatory agencies like the FDA. The acquisition is expected to boost Certara's revenue and adjusted EBITDA, with updated financial guidance anticipated in November 2021.

Certara has launched Synchrogenix Writer, a cloud-based regulatory SaaS product aimed at automating and improving the quality of patient narratives critical for clinical study reporting. This innovative solution addresses the inefficiencies of the traditional manual writing process, which is costly and time-consuming. By enabling data-mapping and early drafting, the software ensures consistency, reduces risk, and accelerates the time to regulatory filing. With over 10,000 patient narratives already delivered, Synchrogenix Writer is positioned to meet evolving global regulatory requirements.

Certara, a leader in biosimulation, expands its Integrated Drug Development division with a new clinical science group led by Philippa Marshall, M.D. This expansion includes important appointments: David Mitchell, Ph.D., as Senior Vice President of Strategic Engagement, and C. Glenn Begley, M.D., Ph.D., and Colin Pillai, Ph.D., as Senior Scientific Advisors. These strategic hires aim to deepen expertise in model-informed drug development and enhance partnerships with various stakeholders, further positioning Certara in the biopharmaceutical sector.

Certara Receives FDA Grant for Biosimulation Model

On September 20, 2021, Certara (Nasdaq: CERT) announced the award of a U.S. FDA grant to enhance its Simcyp MechDermA™ model for assessing virtual bioequivalence in generic drug development. This is the fourth grant awarded to Certara for this purpose. The project aims to verify the predictive performance of biosimulation models, ensuring safer and cost-effective drug development. The Simcyp model previously demonstrated bioequivalence for diclofenac sodium topical gel in 2019, helping to streamline clinical trial requirements.