SLP News & Events

Simulations Plus (SLP) announced a funded research collaboration with Lonza Group (LZAGY) and the U.S. Food and Drug Administration to develop and validate a mechanistic, predictive framework for assessing the in vivo performance of amorphous solid dispersion drug products. ASDs are among the most powerful yet complex oral drug delivery systems, with performance influenced by factors such as food intake, gastric pH, formulation composition, and manufacturing processes. Current regulatory approaches often require multiple clinical bioequivalence studies, which can be resource-intensive while still carrying uncertainty. The collaboration evaluates whether advanced in vitro dissolution systems-particularly those incorporating dynamic gastrointestinal physiology-combined with mechanistic physiologically based biopharmaceutics modeling, can reliably predict key in vivo outcomes, including food effects and the impact of elevated gastric pH conditions. By establishing and validating these predictive capabilities, the collaboration aims to provide a scientific foundation for reducing reliance on certain clinical BE studies while maintaining the rigor and transparency required by regulators. The collaboration brings together complementary capabilities across experimental science and computational modeling. Lonza will lead experimental work, including in vitro dissolution testing under fasted, fed, and elevated gastric pH conditions using advanced systems such as Controlled Transfer Dissolution, as well as the characterization and, where needed, manufacturing of ASD formulation variants. Simulations Plus will lead the development and validation of in vitro-in vivo extrapolation frameworks using its DDDPlus and GastroPlus platforms, translating experimental data into predictions of in vivo pharmacokinetics and supporting virtual bioequivalence assessments. At the same time, it creates new opportunities to extend these capabilities into grounded AI-enabled workflow environments, where data, mechanistic models, and simulation outputs will be more directly connected. The Company will also contribute to interpretation within a regulatory context, ensuring alignment with evolving expectations for model-informed drug development.

While the S&P 500 still had its best week since November, the benchmark gauge for equities closed with a small loss of Friday after a seven-day advance. Markets ended the week in a cautious holding pattern, with momentum from earlier in the week fading.Oil remains volatile as doubts grow around the durability of the Iran ceasefire as disruptions in the Strait of Hormuz persist. Meanwhile, the CPI report showed the sharpest year-over-year price increases for consumers in nearly four years, largely driven by the recent energy shock. Even with a pause in fighting, oil flows remain constrained and supply chains are still disrupted, meaning inflation pressure doesn't immediately disappear. While the ceasefire triggered a global relief rally, investors were on edge Friday as they braced for high-stakes talks being led by Vice President JD Vance this weekend.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:CoreWeaveentered into a multi-yearMeanwhile, Anthropic is exploring designing its own AI chips,TSMCreported ain March net revenueMumbai-based Sun Pharmaceutical Industries has decided to proceed with a binding offer of $12 B for Organon,March's consumer inflation rateto last year, with the consensus expecting 3.4%.2. WALL STREET CALLS:Niketo Neutral at Piper SandlerShake Shackto Outperform at MizuhoServiceNowto Neutral at UBSCiti isin the application software group with six downgrades, including Autodeskand DocuSignIBMwith a Buy at Citi3. AROUND THE WEB:Nike'sinnovation chief Tony Bignell plans to leave the company, WSJ reportsYouTubehas raised prices for YouTube Premium and Music subscriptions, Variety reportsAppleplans to shut down its first unionized store in Maryland, Reuters reportsConocophillipswill evaluate oil prospects in Venezuela, Bloomberg reportsItaly is replacing Leonardochief Roberto Cingolani, Reuters says4. MOVERS:Commvaultrose after Reutersthe company is exploring a saleCars.comwas higher after announcing an increase to its buyback program and anZentalis Pharmaceuticalsgained after Guggenheimon the sharesFair Isaacfell after Barclayson the sharesRobloxwas lower after announcing the5. EARNINGS/GUIDANCE:WD-40reportedand reiterated its FY26 guidanceTecnoglassscut itsBeam GlobalreportedSimulations Plusreportedand cut its FY26 earnings guidanceLotus Technologyreported a year-over-yearINDEXES:The Dow fell 269.23, or 0.56%, to 47,916.57, the Nasdaq gained 80.48, or 0.35%, to 22,902.89, and the S&P 500 declined 7.77, or 0.11%, to 6,816.89.

The major averages were mixed near noon, with the Dow Jones Industrial Average in the red, the Nasdaq higher and the S&P little changed. Markets are ending the week in a cautious holding pattern, with momentum from earlier in the week fading.Oil is creeping higher again, hovering near the $100 per barrel level, as doubts grow around the durability of the Iran ceasefire as disruptions in the Strait of Hormuz persist. Meanwhile, the CPI report showed the sharpest year-over-year price increases for consumers in nearly four years, largely driven by the recent energy shock. Even with a pause in fighting, oil flows remain constrained and supply chains are still disrupted, meaning inflation pressure doesn't immediately disappear.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:CoreWeaveentered into awith AnthropicMeanwhile, Anthropic is exploring designing its own AI chips,TSMCreported ain March net revenueMumbai-based Sun Pharmaceutical Industries has decided to proceed with a binding offer of $12 B for Organon,March's consumer inflation ratecompared to last year, with the consensus expecting 3.4%.2. WALL STREET CALLS:Niketo Neutral at Piper SandlerShake Shackto Outperform at MizuhoServiceNowto Neutral at UBSCiti isin the application software group with six downgrades, including Autodeskand DocuSignIBMwith a Buy at Citi3. AROUND THE WEB:A rumor of a potential takeover approach regarding CommVaultwas highlighted in Ben Harrington's buyout-focused Betaville blogYouTubehas raised prices for YouTube Premium and Music subscriptions, Variety reportsAppleplans to shut down its first unionized store in Maryland, Reuters reportsConocophillipswill evaluate oil prospects in Venezuela, Bloomberg reportsItaly is replacing Leonardochief Roberto Cingolani, Reuters says4. MOVERS:Spire Globalrises after Canaccordon the sharesCars.comhigher after announcing an increase to its buyback program and anZentalis Pharmaceuticalsgains after Guggenheimon the sharesFair Isaaclower after Barclayson the sharesProPetrofalls after Goldman Sachscoverage of the stock with a Neutral rating5. EARNINGS/GUIDANCE:WD-40reportedand reiterated its FY26 guidanceTecnoglassscut itsBeam GlobalreportedSimulations Plusreportedand cut its FY26 earnings guidanceLotus Technologyreported ain Q4 revenueINDEXES:Near midday, the Dow was down 0.46%, or 221.08, to 47,964.72, the Nasdaq was up 0.29%, or 65.34, to 22,887.76, and the S&P 500 was down 0.09%, or 5.87, to 6,818.79.