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Simulations Plus, Inc. provides model-informed and AI-accelerated drug development software, training, and consulting services for biopharmaceutical research. News about the company centers on its software and services segments, scientific modeling engines, ADMET and other modeling workflows, and financial results tied to software renewals, services bookings, and customer activity.
Recurring developments also include collaborations with pharmaceutical companies, technology providers, and regulatory or public-health agencies. These updates cover GPU-accelerated simulation, AI-assisted modeling, predictive frameworks for complex oral drug products, computational toxicology, new approach methodologies, and education programs that expand use of model-informed drug development practices.
Simulations Plus (SLP) on September 17, 2026 announced that the U.S. FDA’s Cosmetics Regulatory Science Branch licensed its ADMET Predictor platform. The new contract expands use of Simulations Plus technology within the FDA for modern cosmetic safety assessment, using integrated exposure and toxicity modeling.
ADMET Predictor combines artificial intelligence and machine learning with proprietary descriptors, premium data and predictive models to estimate endpoint properties and systemic exposure in animals and humans. By coupling high-throughput pharmacokinetic modeling with predictive ADMET and toxicity assessments, the platform lets FDA researchers evaluate potential exposure and intrinsic hazard in a single computational framework, supporting the agency’s New Approach Methodologies (NAMs) for cosmetic safety.
The announcement follows a 2024 research collaboration with the International Collaboration on Cosmetics Safety on physiologically based kinetic modeling for animal-free cosmetic safety, highlighting broader non‑pharmaceutical applications for the company’s technology.
Simulations Plus (Nasdaq: SLP) reported that the waiting period under the U.S. Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired for its previously announced acquisition by Altaris. This expiration fulfills one of the required regulatory conditions for the proposed transaction between Simulations Plus and Altaris.
According to the company, completion of the acquisition still depends on other customary closing conditions defined in the merger agreement. These include approval by Simulations Plus shareholders and obtaining specified regulatory approvals in France. Subject to the satisfaction or waiver of these remaining conditions, the company currently expects the transaction to close in the second half of calendar 2026.
Simulations Plus (Nasdaq:SLP) reported fiscal Q3 2026 revenue up 7% to $21.9 million. Software revenue was flat at $12.6 million (58% of total), while services revenue rose 20% to $9.3 million (42%).
Gross margin improved to 69%. Net income was $3.6 million ($0.18 diluted EPS) versus a prior-year net loss. Adjusted EBITDA was $7.9 million (36% margin), and adjusted diluted EPS was $0.30. For the nine months, revenue grew 5% to $64.6 million, with net income of $8.8 million. On June 15, 2026, the company entered a definitive merger agreement to be acquired by Altaris affiliates, with closing expected in Q4 2026.
Simulations Plus (Nasdaq: SLP) is enhancing Composer, its AI-native platform for model-informed drug development, using the NVIDIA BioNeMo Agent Toolkit. The collaboration connects AI agents, scientific literature, validated computational engines, and GPU-accelerated compute to support agentic drug development workflows.
Initial focus areas include using NVIDIA Nemotron Parse to ground scientific reasoning in traceable literature, and advancing nvQSP with CUDA-optimized ODE solvers to scale quantitative systems pharmacology simulations within Composer.
Simulations Plus (Nasdaq: SLP) agreed to be acquired by Altaris affiliates in an all-cash deal valued at approximately $375 million. Stockholders will receive $18.50 per share in cash, a 26% premium to the 60-day VWAP as of June 15, 2026.
The transaction, unanimously approved by the board, is expected to close in Q4 2026, is not subject to a financing contingency, and is anticipated to be combined with Chemical Computing Group. After closing, Simulations Plus will become private and its shares will be delisted from Nasdaq.
Simulations Plus (Nasdaq: SLP) announced CEO Shawn O’Connor will participate in the 23rd Annual Craig-Hallum Institutional Investor Conference in Minneapolis, Minnesota.
On Thursday, May 28, 2026, he will host one-on-one meetings with institutional investors to discuss the company and its strategy.
Simulations Plus (Nasdaq: SLP) announced a technical collaboration with NVIDIA to deliver GPU-accelerated, AI-assisted modeling workflows for PBPK, PK/PD, and QSP across the drug development lifecycle. The collaboration targets faster simulation, parallel parameter exploration, and interactive AI-assisted model construction.
Initial testing reports up to a 75% reduction in end-to-end QSP modeling time; companies plan pilot engagements with select pharmaceutical partners and will apply NVIDIA BioNeMo and GPU-native optimization to scale workflows.
Simulations Plus (Nasdaq: SLP) announced a funded research collaboration with Lonza and the U.S. FDA to develop and validate a mechanistic predictive framework for amorphous solid dispersion (ASD) oral products.
The program pairs Lonza's advanced in vitro dissolution testing with Simulations Plus' DDDPlus and GastroPlus platforms to build IVIVE and virtual bioequivalence methods, aiming to improve prediction of food and elevated gastric pH effects and potentially reduce reliance on certain clinical bioequivalence studies while aligning with regulatory MIDD priorities.
Simulations Plus (Nasdaq: SLP) completed its 2026 Spring School March 23–27, 2026, training over 1,400 scientists from more than 65 countries in model-informed drug development (MIDD).
The week-long program offered GastroPlus and MonolixSuite tracks with lectures, hands-on exercises, and live Q&A to broaden applied modeling expertise globally.
Simulations Plus (Nasdaq: SLP) reported Q2 fiscal 2026 results: revenue $24.3M (+8% YoY), software $14.6M (60%), services $9.7M (40%). Gross profit was $16.1M (66%). Net income was $4.5M; diluted EPS $0.22. Adjusted EBITDA was $8.7M (36% of revenue).
Six-month revenue was $42.7M (+3%). Management lowered fiscal 2026 adjusted diluted EPS guidance to $0.75–$0.85 due to an increased expected effective tax rate of 23–25%. Revenue guidance remains $79M–$82M.