Simulations Plus, Inc. (NASDAQ:SLP) announced a funded research collaboration with Lonza Group AG and the U.S. Food and Drug Administration to develop and validate a predictive framework for complex oral drug products. The partnership focuses on amorphous solid dispersion (ASD) formulations, a class of products that present significant formulation challenges and are increasingly important in the biopharma pipeline.
The collaboration is designed to advance regulatory acceptance of in‑silico modeling for oral drug products, leveraging Simulations Plus’s expertise in physiologically based pharmacokinetic (PBPK) modeling and Lonza’s manufacturing capabilities. By working directly with the FDA, the project aims to create a validated framework that could streamline development timelines and reduce reliance on animal testing for these formulations.
Simulations Plus also reported its second‑quarter fiscal 2026 financial results. Adjusted earnings per share were $0.35, beating analyst estimates of $0.29 and representing a 20.69% beat. Revenue reached $24.29 million, surpassing the consensus estimate of $21.66 million. The earnings beat reflects strong demand for the company’s software and services and disciplined cost management, while the revenue growth is driven by continued adoption of its model‑informed drug development solutions across the industry.
In addition, the company completed its 2026 Spring School on April 20, 2026. The global training initiative, held from March 23 to March 27, attracted more than 1,400 scientists from over 65 countries, reinforcing Simulations Plus’s role as a key educational partner and potentially driving future adoption of its software and services.
Dr. Viera Lukacova, Chief Scientific Officer, said, “Complex oral formulations such as amorphous solid dispersions present significant scientific and regulatory challenges due to their sensitivity to physiological and manufacturing variables.” Jonathan Chauvin, Co‑Chief Product and Technology Officer, added, “Through programs like Spring School, we are expanding access to these capabilities to support the next generation of scientists, while enabling broader adoption of model‑informed workflows across the industry.”
The collaboration and the Spring School underscore Simulations Plus’s strategic focus on advancing model‑informed drug development and expanding its global footprint. The partnership with the FDA and Lonza positions the company to influence regulatory pathways for ASDs, while the educational initiative builds a pipeline of talent equipped to apply its tools. Together, these initiatives support the company’s growth trajectory and reinforce its leadership in the MIDD space.
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