SIMULATIONS PLUS WKN: 924294 ISIN: US8292141053 Kürzel: SLP Forum: Aktien Thema: Hauptdiskussion

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drug development that advances biopharma innovation, today responded to the U.S. Food and Drug Administration’s draft guidance on streamlined nonclinical safety studies for monospecific monoclonal antibodies.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 “The FDA’s draft guidance signals a clear regulatory mandate towards mechanistic, model-informed science, and Simulations Plus is uniquely positioned to help clients respond with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 capabilities have supported these integrated approaches for years.”