Certara announced that the U.S. Food and Drug Administration has accepted its Simcyp Simulator–based physiologically‑based pharmacokinetic (PBPK) modeling predictions as a substitute for the clinical pharmacology studies required in the new drug application for asciminib (Scemblix®), a first‑in‑class allosteric inhibitor for chronic myeloid leukemia.
The acceptance follows a decade‑long collaboration between Certara and Novartis, during which the Simcyp Simulator was used to evaluate asciminib’s pharmacokinetics across diverse patient populations, dosing regimens, and drug‑interaction scenarios. The FDA’s decision removes the need for ten human trials, accelerating the drug’s path to market and underscoring the regulatory credibility of Certara’s biosimulation platform.
This milestone strengthens Certara’s strategy to position its integrated Model‑Informed Drug Development (MIDD) platform as the default tool for regulatory submissions. By enabling the FDA to rely on in‑silico data, Certara expands its addressable market from discovery through market access and reinforces its competitive moat in a field where regulatory acceptance of modeling is rapidly growing.
Certara’s Q4 2025 financial results showed revenue of $103.6 million, up 3% year‑over‑year, while earnings per share missed expectations at $0.09 versus an estimated $0.11. Software revenue grew 10% YoY, offsetting a slight decline in services revenue, and the company guided FY 2026 revenue growth of 0–4%. The regulatory win is expected to bolster demand for Certara’s software solutions, potentially improving the company’s revenue mix and supporting its modest growth outlook.
Rob Aspbury, President of Certara Predictive Technologies, said, “This collaboration exemplifies the scientific partnership that the Simcyp Simulator enables. The modeling work for asciminib evolved over a decade and contributed to richer understanding its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval and an important new treatment for patients with CML.”
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