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) is a leading provider of decision support technology and consulting services designed to optimize drug development and improve health outcomes. The company's suite of solutions spans the entire drug development and patient care lifecycle, employing advanced modeling and simulation technologies along with cutting-edge regulatory strategies. Certara's services are pivotal in increasing the probability of both regulatory and commercial success for their clients, which include over 2,300 global biopharmaceutical companies, leading academic institutions, and major regulatory agencies across 70 countries.
Certara's core business revolves around leveraging biosimulation software and technology to transform traditional drug discovery and development processes. By using its innovative modeling and simulation tools, the company aids clients in reducing the need for extensive clinical trials, thereby accelerating regulatory approvals and enhancing patient access to new therapies. Their product suite includes regulatory science, assessment software, and a range of consulting services, all aimed at streamlining drug development.
One of Certara's notable achievements is its collaboration with the FDA on physiologically-based pharmacokinetic (PBPK) modeling for virtual bioequivalence (VBE) and predicting drug absorption of topical formulations. These initiatives aim to replace costly and time-consuming clinical bioequivalence studies with efficient virtual simulations, thus speeding up the development process and reducing costs. The Simcyp Simulator, a key component of Certara's technology, has already proven its utility in replacing clinical studies in VBE and dermal absorption scenarios.
Certara's business operations are primarily concentrated in the Americas, generating significant revenue from this region, with additional market presence in EMEA and the Asia Pacific. The company continues to expand its software portfolio with innovations like the Simcyp™ Biopharmaceutics software, which helps drug developers optimize formulations for complex therapies, and the recently launched Certara Cloud, a unified platform that integrates their scientific software solutions for seamless workflow management.
Financially, Certara has reiterated its full-year guidance for 2024, showcasing a stable outlook and ongoing commitment to delivering high-quality, innovative solutions. Their recent acquisition of Applied BioMath underscores their growth strategy, enhancing their capabilities in quantitative systems pharmacology (QSP) to de-risk and accelerate therapeutic R&D. The combined expertise positions Certara as the largest QSP center of excellence, further strengthening their role in the life sciences industry.
For more information, visit www.certara.com.
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.
Certara, Inc. (Nasdaq: CERT) announced the successful closure of its public offering, selling 23,000,000 shares at $31.00 each, generating approximately $139.5 million in gross proceeds. This total includes an additional 3,000,000 shares from underwriters' option. Certara sold 4,500,000 shares while selling stockholders contributed 18,500,000 shares. The proceeds will be utilized for general corporate purposes, including acquisitions. The offering was managed by Jefferies, Morgan Stanley, and BofA Securities, among others.
Certara, Inc. (Nasdaq: CERT) has announced its public offering of 4.5 million shares, priced at $31.00 each, aiming for gross proceeds of approximately $139.5 million. Additionally, existing stockholders are offering 15.5 million shares, with underwriters given a 30-day option for an extra 3 million shares. The net proceeds will support general corporate purposes, including acquisitions. The offering is led by Jefferies, Morgan Stanley, and BofA Securities, with closing expected on or around September 13, 2021.
Certara, Inc. (Nasdaq: CERT) announced a proposed underwritten public offering of 20 million shares of its common stock. Certara aims to offer 4.5 million shares directly, while selling stockholders will offer 15.5 million shares. Additionally, there is a potential for underwriters to purchase up to 3 million additional shares. The net proceeds from the shares offered by Certara will be used for general corporate purposes including acquisitions. The offering is led by Jefferies, Morgan Stanley, and BofA Securities.
Certara, a leader in biosimulation, announced participation in upcoming virtual investor conferences. Key events include the Morgan Stanley Global Healthcare Conference on September 14 at 9:30 a.m. ET, featuring CEO William Feehery and CFO Andrew Schemick; the Baird Global Healthcare Conference on September 15 at 4:55 p.m. ET, with CFO Andrew Schemick; and the Bank of America Securities Drug Discovery Conference on September 20 at 8:00 a.m. ET, with both executives. Live webcasts will be available on Certara’s investor relations website for 90 days.
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