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Stock impact report

Certara Simcyp® Simulator Results Replace Ten Human Trials for Chronic Myeloid Leukemia (CML) Therapy asciminib [Yahoo! Finance]

Certara, Inc. (CERT) 
Company Research Source: Yahoo! Finance
Certara Biosimulation results highlight how model-informed approaches for drug development and regulatory decision-making save time and money. RADNOR, Pa., March 03, 2026 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today 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 (NDA) for asciminib (Scemblix ® ). 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 ” (Loisios-Konstantinidis et al.), highlight the growing impact and business be Show less Read more
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