Welcome to our dedicated page for Simulations Plus news (Ticker: SLP), a resource for investors and traders seeking the latest updates and insights on Simulations Plus stock.
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 (Nasdaq: SLP) will report second quarter fiscal 2026 results after the market close on Thursday, April 9, 2026, with a management conference call the same day at 5:00 p.m. ET.
Investors can join a live webcast via the company investor relations site, dial domestic or international conference numbers, or use a Call me™ return-call link; a replay will be available about one hour after the call.
Simulations Plus (Nasdaq: SLP) announced strategic collaboration programs with three large pharmaceutical companies to advance AI-enabled, model-informed drug development workflows.
The programs will integrate the company’s AI agents into its platforms (GastroPlus®, MonolixSuite™, ADMET Predictor®, Thales™) to enable natural-language interaction, automated data processing, coordinated simulations, and governance standards for enterprise deployment.
Simulations Plus (Nasdaq: SLP) convenes industry and regulatory leaders for a panel, “From Debate to Deployment: Responsible, Practical AI in MIDD,” on March 5, 2026 at the ASCPT Annual Meeting in Denver.
Panelists will discuss current AI use in model‑informed drug development, build vs buy decisions, regulatory principles, and human roles in AI integration.
Simulations Plus (Nasdaq: SLP) announced extensions of two research collaborations with the U.S. Food and Drug Administration and the National Institute of Environmental Health Sciences. The projects advance AI-enabled computational toxicity models and new approach methodologies (NAMs) for food, chemical, and environmental safety assessment. The FDA extension expands access to curated toxicological datasets for further training, validation, and benchmarking of Simulations Plus’ AI/ML models. The NIEHS extension continues application of the company’s software to design, validate, and benchmark experimental systems under national chemical safety modernization efforts.
Simulations Plus (Nasdaq: SLP) announced CEO Shawn O’Connor will participate in multiple investor conferences in February–March 2026, including BTIG (Feb 10, Snowbird, UT), TD Cowen (Mar 3, Boston, MA) and KeyBanc (Mar 18, virtual).
Formats include one-on-one meetings and fireside chats; webcast links will be available on the company Investor Relations site.
Simulations Plus (Nasdaq: SLP) hosted a 2026 Virtual Investor Day on January 21, 2026, outlining its strategy to evolve from best-in-class tools into an integrated, AI-enabled modeling ecosystem for drug development.
The company emphasized alignment with FDA and EMA principles for good AI practice, combining mechanistic modeling, AI-assisted workflows, cloud execution, and regulator-ready reproducibility to address rising scientific complexity and demand for in silico evidence.
Executive leaders highlighted priorities: validated science, transparency, traceability, and enterprise infrastructure to support customers and regulators.
Simulations Plus (Nasdaq: SLP) reported Q1 FY2026 results for the quarter ended Nov 30, 2025: total revenue $18.4M (down 3% YoY), software revenue $8.9M (down 17%), services revenue $9.5M (up 16%). Gross profit was $10.9M with gross margin 59% (versus 54% prior year). GAAP net income was $0.7M (diluted EPS $0.03); adjusted net income was $2.6M (adjusted diluted EPS $0.13). Adjusted EBITDA was $3.5M (19% of revenue). The company reaffirmed FY2026 guidance: revenue $79M–$82M, software mix 57–62%, adjusted diluted EPS $1.03–$1.10, and adjusted EBITDA margin 26–30%. A virtual Investor Day is scheduled for Jan 21, 2026.
Simulations Plus (Nasdaq: SLP) will host a virtual Investor Day on January 21, 2026 to outline its long-term strategy for model-informed drug development (MIDD).
The 90-minute webcast (1:00 PM–2:30 PM ET) will cover the company’s unified product and technology strategy, advances in scientific services across the drug lifecycle, the industry environment and accelerating adoption of MIDD, and the company’s financial priorities and outlook, followed by a leadership Q&A. A replay will be posted after the event.
Simulations Plus (NASDAQ: SLP) will report first quarter fiscal 2026 results after market close on Thursday, January 8, 2026. Management will host a conference call the same day at 5:00 p.m. Eastern Time to discuss the results.
Investors can join via live webcast (registration required), dial 1-877-451-6152 (U.S.) or 201-389-0879 (international), or request a return call via Call me™. A replay will be available on the company investor relations page approximately one hour after the call.
Simulations Plus (Nasdaq: SLP) on December 9, 2025 positioned its validated modeling engines and AI-orchestrated ecosystem to respond to the FDA's draft guidance on streamlined nonclinical safety studies for monospecific monoclonal antibodies. The company highlights integration of PBPK (GastroPlus), QST/QSP (BIOLOGXsym), and population modeling (MonolixSuite) to support weight-of-evidence assessments and reduced animal testing.
Simulations Plus plans continued biologics modeling enhancements and frames its tools as aligned with FDA emphasis on mechanistic, model-informed nonclinical decision-making.