Simulations Plus Positioned to Capitalize on FDA’s Streamlined Nonclinical Safety Guidance with Advanced Mechanistic and Model-Informed Solutions
Simulations Plus, Inc. (SLP)
Last simulations plus, inc. earnings: 4/9 04:35 pm
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Source: Business Wire
Validated engines and AI-orchestrated ecosystem align with the emerging regulatory framework RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today responded to the U.S. Food and Drug Administration’s draft guidance on streamlined nonclinical safety studies for monospecific monoclonal antibodies. The guidance encourages reduced reliance on animal studies and elevates mechanistic understanding, pharmacokinetics, and integrated weight-of-evidence (WoE) assessments for nonclinical decision-making.“The FDA’s draft guidance signals a clear regulatory mandate towards mechanistic, model-informed science, and Simulations Plus is uniquely positioned to help clients respond with confidence,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Our scientific engines, workflows, and cross-disciplinary
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SLP
Earnings
- 12/1/25 - In-Line
SLP
Sec Filings
- 12/8/25 - Form 8-K
- 12/2/25 - Form 4
- 12/1/25 - Form 144
- SLP's page on the SEC website