{"success":true,"data":{"pressRelease":{"id":"146995","rtpr_id":"nBw1d929Xa-20260917","ticker":"SLP","exchange":"NASDAQ","all_tickers":["SLP"],"title":"Simulations Plus Expands FDA Adoption of ADMET Predictor® with New Licenses for the Cosmetics Regulatory Science Branch","author":"Business Wire","published_at":"2026-09-17T21:45:00.098Z","article_body":"Simulations Plus Expands FDA Adoption of ADMET Predictor® with New Licenses\nfor the Cosmetics Regulatory Science Branch\n\nAgency will use the software platform to support modern cosmetic safety\nassessment through integrated exposure and toxicity modeling.\n\nSimulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the\n“Company”), a global leader in model-informed and AI-accelerated drug\ndevelopment that advances biopharma innovation, today announced that the U.S.\nFood and Drug Administration’s (FDA) Cosmetics Regulatory Science Branch has\nlicensed ADMET Predictor® to support its computational research for modern\ncosmetic safety assessment. The contract expands the use of Simulations Plus\ntechnology within the FDA, underscoring the growing importance of predictive\nmodeling and mechanistic science in advancing regulatory research.\n\nThe ADMET Predictor platform provides researchers with advanced artificial\nintelligence and machine learning (AI/ML) technology, novel descriptors,\npremium data, and predictive models to rapidly predict endpoint properties and\nsystemic exposure in animals and humans.\n\nBy coupling high-throughput pharmacokinetic (HTPK) modeling with predictive\nADMET and toxicity assessments, ADMET Predictor provides FDA researchers in\nthe Cosmetic Regulatory Science Branch with tools to evaluate both potential\nexposure and intrinsic hazard within a unified computational framework. The\ndevelopment of modern, science-based approaches to cosmetic safety assessment\nsupports the FDA's ongoing research into New Approach Methodologies (NAMs).\n\nThe announcement builds on Simulations Plus’ work in computational safety\nassessment beyond pharmaceuticals. In 2024, the Company announced a research\ncollaboration with the International Collaboration on Cosmetics Safety (ICCS)\nto evaluate physiologically based kinetic (PBK) modeling approaches that\nsupport animal-free safety assessment of cosmetics and other\nnon-pharmaceutical ingredients. Together, these initiatives help to reinforce\nthe expanding role of Simulations Plus technologies in advancing predictive\nscience across regulated industries.\n\n“We are proud that ADMET Predictor is trusted by researchers working in\nindustry, academia, and regulatory agencies globally,” said Shawn\nO’Connor, Chief Executive Officer of Simulations Plus. “The FDA’s\nadoption of ADMET Predictor within its Cosmetics Regulatory Science Branch\nexpands our relationship with one of the world’s leading regulatory\norganizations and reflects growing confidence in predictive modeling and\nmechanistic science as essential components supporting NAMs and advancing the\nfuture of regulatory science. We believe it also highlights the versatility of\nour technology beyond pharmaceutical research and reinforces our leadership in\ncomputational solutions for non-pharmaceutical markets.”\n\nAbout Simulations Plus, Inc.\n\nSimulations Plus is a global leader in model-informed and AI-accelerated drug\ndevelopment. We create value for our clients by accelerating the discovery,\ndevelopment, and commercialization of pharmaceuticals and other products\nthrough innovative science-based software and consulting solutions. For more\ninformation, visit www.simulations-plus.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fnam12.safelinks.protection.outlook.com%2F%3Furl%3Dhttp%253A%252F%252Fwww.simulations-plus.com%252F%26data%3D05%257C02%257Cchristina.hendrickson%2540simulations-plus.com%257Ce00a5e418fc14363254b08de337406c4%257Ca6fe9a739e054efcb9b3f4cc5eab196c%257C0%257C0%257C639004771726597036%257CUnknown%257CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%253D%253D%257C0%257C%257C%257C%26sdata%3DVl%252BNsGSLmZtDcsrlp0M1V9NI3JD3jT5%252BD3bn1M3Ffn8%253D%26reserved%3D0&esheet=54606542&newsitemid=20260917938732&lan=en-US&anchor=www.simulations-plus.com&index=1&md5=dd14346e66d72482323f7298ab92509e)\n.\n\nForward-Looking Statements\n\nExcept for historical information, the matters discussed in this press release\nare forward-looking statements that involve risks and uncertainties. Words\nlike “believe,” “will”, “can”, “expect,” “anticipate,” and\nsimilar expressions (or the negative of such terms, as well as other words or\nexpressions referencing future events, conditions, or circumstances) mean that\nthese are our best estimates as of this writing, but there can be no\nassurances that expected or anticipated results or events will actually take\nplace, so our actual future results could differ significantly from those\nstatements. Forward-looking statements include but are not limited to\nregarding the anticipated use, capabilities and potential applications of\nADMET Predictor®, the role of predictive modeling, mechanistic science and\nNew Approach Methodologies in regulatory research, the Company’s expansion\ninto non-pharmaceutical markets, and the potential benefits and applications\nof the Company’s software and technologies. These forward-looking statements\nare based on current assumptions and expectations that involve risks and\nuncertainties that could cause the actual results to differ materially from\nthose expressed or implied. Factors that could cause or contribute to such\ndifferences include, but are not limited to: effectiveness of our internal\noperational structure, our ability to maintain our competitive advantages and\ncommercialize AI and cloud-enabled solutions, evolving regulatory and data\nprivacy standards governing AI technologies, acceptance of new software and\nimproved versions of our existing software by our customers, the general\neconomics of the pharmaceutical industry, our ability to finance growth, our\nability to continue to attract and retain highly qualified technical staff,\nmarket conditions, macroeconomic factors, and a sustainable market. Further\ninformation on our risk factors is contained in our quarterly, annual, and\ncurrent reports and filed with the U.S. Securities and Exchange Commission. No\nregulatory authority has endorsed, approved, or validated the Company’s\nproducts, platforms, or AI-related approaches.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260917938732/en/\n(https://www.businesswire.com/news/home/20260917938732/en/)\n\nInvestor Relations Contact:\n\nLisa Fortuna\n\nFinancial Profiles\n\n310-622-8251\n\nslp@finprofiles.com (mailto:slp@finprofiles.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw1d929Xa-20260917","title":"Simulations Plus Expands FDA Adoption of ADMET Predictor® with New Licenses for the Cosmetics Regulatory Science Branch","author":"Business Wire","ticker":"SLP","created":"2026-09-17T21:45:00.098Z","tickers":["SLP"],"exchange":"NASDAQ","article_body":"Simulations Plus Expands FDA Adoption of ADMET Predictor® with New Licenses\nfor the Cosmetics Regulatory Science Branch\n\nAgency will use the software platform to support modern cosmetic safety\nassessment through integrated exposure and toxicity modeling.\n\nSimulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the\n“Company”), a global leader in model-informed and AI-accelerated drug\ndevelopment that advances biopharma innovation, today announced that the U.S.\nFood and Drug Administration’s (FDA) Cosmetics Regulatory Science Branch has\nlicensed ADMET Predictor® to support its computational research for modern\ncosmetic safety assessment. The contract expands the use of Simulations Plus\ntechnology within the FDA, underscoring the growing importance of predictive\nmodeling and mechanistic science in advancing regulatory research.\n\nThe ADMET Predictor platform provides researchers with advanced artificial\nintelligence and machine learning (AI/ML) technology, novel descriptors,\npremium data, and predictive models to rapidly predict endpoint properties and\nsystemic exposure in animals and humans.\n\nBy coupling high-throughput pharmacokinetic (HTPK) modeling with predictive\nADMET and toxicity assessments, ADMET Predictor provides FDA researchers in\nthe Cosmetic Regulatory Science Branch with tools to evaluate both potential\nexposure and intrinsic hazard within a unified computational framework. The\ndevelopment of modern, science-based approaches to cosmetic safety assessment\nsupports the FDA's ongoing research into New Approach Methodologies (NAMs).\n\nThe announcement builds on Simulations Plus’ work in computational safety\nassessment beyond pharmaceuticals. In 2024, the Company announced a research\ncollaboration with the International Collaboration on Cosmetics Safety (ICCS)\nto evaluate physiologically based kinetic (PBK) modeling approaches that\nsupport animal-free safety assessment of cosmetics and other\nnon-pharmaceutical ingredients. Together, these initiatives help to reinforce\nthe expanding role of Simulations Plus technologies in advancing predictive\nscience across regulated industries.\n\n“We are proud that ADMET Predictor is trusted by researchers working in\nindustry, academia, and regulatory agencies globally,” said Shawn\nO’Connor, Chief Executive Officer of Simulations Plus. “The FDA’s\nadoption of ADMET Predictor within its Cosmetics Regulatory Science Branch\nexpands our relationship with one of the world’s leading regulatory\norganizations and reflects growing confidence in predictive modeling and\nmechanistic science as essential components supporting NAMs and advancing the\nfuture of regulatory science. We believe it also highlights the versatility of\nour technology beyond pharmaceutical research and reinforces our leadership in\ncomputational solutions for non-pharmaceutical markets.”\n\nAbout Simulations Plus, Inc.\n\nSimulations Plus is a global leader in model-informed and AI-accelerated drug\ndevelopment. We create value for our clients by accelerating the discovery,\ndevelopment, and commercialization of pharmaceuticals and other products\nthrough innovative science-based software and consulting solutions. For more\ninformation, visit www.simulations-plus.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fnam12.safelinks.protection.outlook.com%2F%3Furl%3Dhttp%253A%252F%252Fwww.simulations-plus.com%252F%26data%3D05%257C02%257Cchristina.hendrickson%2540simulations-plus.com%257Ce00a5e418fc14363254b08de337406c4%257Ca6fe9a739e054efcb9b3f4cc5eab196c%257C0%257C0%257C639004771726597036%257CUnknown%257CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%253D%253D%257C0%257C%257C%257C%26sdata%3DVl%252BNsGSLmZtDcsrlp0M1V9NI3JD3jT5%252BD3bn1M3Ffn8%253D%26reserved%3D0&esheet=54606542&newsitemid=20260917938732&lan=en-US&anchor=www.simulations-plus.com&index=1&md5=dd14346e66d72482323f7298ab92509e)\n.\n\nForward-Looking Statements\n\nExcept for historical information, the matters discussed in this press release\nare forward-looking statements that involve risks and uncertainties. Words\nlike “believe,” “will”, “can”, “expect,” “anticipate,” and\nsimilar expressions (or the negative of such terms, as well as other words or\nexpressions referencing future events, conditions, or circumstances) mean that\nthese are our best estimates as of this writing, but there can be no\nassurances that expected or anticipated results or events will actually take\nplace, so our actual future results could differ significantly from those\nstatements. Forward-looking statements include but are not limited to\nregarding the anticipated use, capabilities and potential applications of\nADMET Predictor®, the role of predictive modeling, mechanistic science and\nNew Approach Methodologies in regulatory research, the Company’s expansion\ninto non-pharmaceutical markets, and the potential benefits and applications\nof the Company’s software and technologies. These forward-looking statements\nare based on current assumptions and expectations that involve risks and\nuncertainties that could cause the actual results to differ materially from\nthose expressed or implied. Factors that could cause or contribute to such\ndifferences include, but are not limited to: effectiveness of our internal\noperational structure, our ability to maintain our competitive advantages and\ncommercialize AI and cloud-enabled solutions, evolving regulatory and data\nprivacy standards governing AI technologies, acceptance of new software and\nimproved versions of our existing software by our customers, the general\neconomics of the pharmaceutical industry, our ability to finance growth, our\nability to continue to attract and retain highly qualified technical staff,\nmarket conditions, macroeconomic factors, and a sustainable market. Further\ninformation on our risk factors is contained in our quarterly, annual, and\ncurrent reports and filed with the U.S. Securities and Exchange Commission. No\nregulatory authority has endorsed, approved, or validated the Company’s\nproducts, platforms, or AI-related approaches.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260917938732/en/\n(https://www.businesswire.com/news/home/20260917938732/en/)\n\nInvestor Relations Contact:\n\nLisa Fortuna\n\nFinancial Profiles\n\n310-622-8251\n\nslp@finprofiles.com (mailto:slp@finprofiles.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-09-17T21:45:00.149021731Z","server_sent_at_ms":1789681500149},"received_at":"2026-09-17T21:45:00.204Z","source_url":"https://www.businesswire.com/news/home/20260917938732/en/"},"analysis":{"id":"135827","press_release_id":"146995","analysis_json":{"industry":{"label":"Health Care Technology","sector":"Health Care"},"redFlags":["No financial terms or contract value disclosed for the FDA license","Release explicitly states no regulatory authority has endorsed, approved, or validated the company's products — 'FDA adoption' is a research-use software license, not an endorsement"],"eventType":"operations_update","narrative":"The FDA's Cosmetics Regulatory Science Branch has licensed ADMET Predictor, Simulations Plus' AI/ML-driven predictive modeling platform, to support computational research for modern cosmetic safety assessment.\n\nThe contract expands the company's use of its technology within the FDA, pairing high-throughput pharmacokinetic modeling with predictive ADMET and toxicity tools to support the agency's New Approach Methodologies (NAMs) research.\n\nIt builds on a 2024 research collaboration with the International Collaboration on Cosmetics Safety evaluating PBK modeling for animal-free safety assessment. No financial terms of the new license were disclosed.\n\nCEO Shawn O'Connor framed the deal as evidence of the platform's versatility beyond pharmaceutical research, though the release notes no regulatory authority has endorsed or validated the company's products.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Regulator-as-customer validation for SLP's AI/ML safety modeling platform, though immaterial financially until license economics are disclosed."},"keyFigures":{},"quotedText":"adoption of ADMET Predictor within its Cosmetics Regulatory Science Branch","namedEntities":{"people":[{"name":"Shawn O'Connor","role":"CEO of Simulations Plus"}],"products":["ADMET Predictor"],"companies":[{"name":"Simulations Plus, Inc.","ticker":"SLP","relationship":"filer"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"customer / regulator"},{"name":"International Collaboration on Cosmetics Safety (ICCS)","relationship":"research collaborator"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"A software license win with the FDA's Cosmetics Regulatory Science Branch is meaningful third-party validation and expands SLP's regulator relationships, but no financial terms are disclosed and the deal is unlikely to move near-term financials materially."},"tickerRelevance":{"others":[],"primary":"SLP"},"globalImportance":15,"audienceRelevance":14,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"software-license-contract-win","sectorWeight":"healthcare-technology-niche","validationSignal":"regulator-as-customer","financialTermsDisclosed":false}},"event_type":"operations_update","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"The FDA's Cosmetics Regulatory Science Branch has licensed ADMET Predictor, Simulations Plus' AI/ML-driven predictive modeling platform, to support computational research for modern cosmetic safety assessment.\n\nThe contract expands the company's use of its technology within the FDA, pairing high-throughput pharmacokinetic modeling with predictive ADMET and toxicity tools to support the agency's New Approach Methodologies (NAMs) research.\n\nIt builds on a 2024 research collaboration with the International Collaboration on Cosmetics Safety evaluating PBK modeling for animal-free safety assessment. No financial terms of the new license were disclosed.\n\nCEO Shawn O'Connor framed the deal as evidence of the platform's versatility beyond pharmaceutical research, though the release notes no regulatory authority has endorsed or validated the company's products.","key_figures":{},"named_entities":{"people":[{"name":"Shawn O'Connor","role":"CEO of Simulations Plus"}],"products":["ADMET Predictor"],"companies":[{"name":"Simulations Plus, Inc.","ticker":"SLP","relationship":"filer"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"customer / regulator"},{"name":"International Collaboration on Cosmetics Safety (ICCS)","relationship":"research collaborator"}],"dollarAmounts":[]},"model_name":"glm-5.3-flash","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-17T21:45:39.553Z","global_importance":15,"audience_relevance":14,"importance_components":{"tickerTier":"small-cap","eventGravity":"software-license-contract-win","sectorWeight":"healthcare-technology-niche","validationSignal":"regulator-as-customer","financialTermsDisclosed":false}},"durationMs":39341,"modelName":"glm-5.3-flash"}}