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Simulations Plus, Inc. (NASDAQ: SLP) is a leading developer of modeling and simulation software and consulting services that support drug discovery, development research, and regulatory submissions. The company collaborates with pharmaceutical organizations to implement a data-driven, strategic modeling methodology that begins in early discovery stages, extends through preclinical and clinical development, and continues into clinical trials and post-approval phases.
Simulations Plus, through its subsidiaries Cognigen Corporation and DILIsym Services, offers a suite of top-ranked, user-friendly software solutions. These include GastroPlus™, ADMET Predictor™, KIWI™, DILIsym®, NAFLDsym®, PKPlus™, and more. These tools bridge data mining and compound library screening with QSAR models and PBPK/TK modeling and simulation in both animals and humans. The company's quantitative systems pharmacology approaches are widely recognized and licensed by regulatory agencies globally.
In addition to software development, Simulations Plus provides consulting and contract research services to the pharmaceutical industry. The company’s operations are divided into two primary segments: software and services. The software segment generates the majority of the company’s revenue.
Over the past 20 years, Simulations Plus has consistently partnered with clients to reduce costs and accelerate research timelines. The company’s innovative technology and methodologies have earned it a reputation as a reliable partner in the pharmaceutical industry.
Latest News: Simulations Plus continues to make headlines with its innovative solutions and strategic partnerships. Stay updated with the latest developments and achievements of Simulations Plus on our news section.
Simulations Plus, Inc. (NASDAQ: SLP) has been awarded a funded contract by the FDA in collaboration with the University of Connecticut. This contract aims to enhance mechanistic in vitro/in vivo correlation (IVIVC) methods for long-acting injectable (LAI) formulations. Dr. Diane Burgess and her lab will generate data for marketed LAI products, while Simulations Plus will develop physiologically based models to establish bioequivalence, potentially reducing regulatory burden. This collaboration marks a significant step in advancing modeling and simulation technology in drug development.
Simulations Plus, Inc. (Nasdaq: SLP) reported a 12% year-over-year revenue increase to $46.5 million for fiscal 2021, with software revenue rising 28% to $27.7 million. In Q4, total revenue was $9.8 million, a 3% increase, while software revenue grew 14% to $5.4 million. Despite a 7% decline in services revenue, gross profit was $7.1 million with a 72% gross margin. For fiscal 2022, the company projects total revenue between $51 million and $53 million, indicating 10% to 15% growth.
Simulations Plus (NASDAQ: SLP) has launched a new University+ Program offering free access to its modeling and simulation software for one year to students and educators at accredited universities worldwide. This initiative celebrates the company's 25th anniversary and aims to enhance education in Modeling and Simulation (M&S). Eligibility for renewal is available under certain conditions. The program seeks to prepare future scientists for careers in drug development and related fields, fostering academic research and collaboration.
Simulations Plus, Inc. has declared a quarterly cash dividend of
Simulations Plus, Inc. (NASDAQ: SLP) will report its fourth quarter and full year financial results for fiscal year 2021, concluding on August 31, 2021, after market close on October 25, 2021. A conference call will follow at 5:00 PM ET that day, allowing stakeholders to discuss financial outcomes and future strategies. The call can be accessed via registration or dial-in. This announcement signifies an important upcoming milestone for the company in detailing its financial performance and operational updates.
Simulations Plus has received a cooperative agreement from the FDA, providing $250,000 annually for two years to enhance its GastroPlus® platform. This funding aims to improve the Transdermal Compartmental Absorption and Transit (TCAT™) model for better simulations of dermal formulations. The project will involve collaboration with leading pharmaceutical and research organizations, focusing on developing innovative strategies for regulatory assessments. This initiative strengthens the company's position in drug modeling and simulation, particularly in dermatology.
Simulations Plus, Inc. (Nasdaq: SLP) announced the release of version 10.3 of its ADMET Predictor platform, now marketed as APX.3. This update introduces enhanced AI capabilities, including a new AI-driven Drug Design Module that integrates third-party calculations for compound optimization. Key improvements include an updated CYP metabolism model and the MedChem Studio™ accessibility for all users, designed to bolster data visualization and analysis. The features aim to expand the client base and maintain double-digit revenue growth as the company enters its 2022 fiscal year.
Simulations Plus, Inc. (Nasdaq: SLP) announced that CEO Shawn O’Connor will present at the BofA Securities 2021 Tech Solutions for Drug Discovery Conference on September 20, 2021, at 10:00 a.m. ET, and at the Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit on September 22, 2021, at 9:55 a.m. ET. One-on-one meetings will also be held at both events. Live webcasts and presentations will be accessible via the Investors page of the Simulations Plus website for 90 days.
Simulations Plus (Nasdaq: SLP) announced promising results from the second phase of a collaborative research project with a major pharmaceutical company. Nearly 30% of the 19 synthesized molecules demonstrated activity below 50 nM, indicating strong therapeutic potential. The predictive errors in rat and human microsomal clearance were improved by three-fold, showcasing advancements in the Artificial Intelligence-driven Drug Design (AIDD) Module of ADMET Predictor. The company plans to present further details in the coming months, along with functional updates to be released this fall.
Simulations Plus, Inc. (Nasdaq: SLP) has received a significant order from China's National Medical Products Administration (NMPA) to add licenses for its GastroPlus® software. This development underscores the growing adoption of physiologically based biopharmaceutics modeling in drug development. Division president John DiBella highlighted the expanding relationships with the NMPA and the positive impact on over 20 domestic Chinese pharmaceutical companies. The initiative aims to enhance regulatory review processes, potentially reducing time to market for new medicines, benefiting both companies and patients.
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