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0.00576368876080692 -0.0115273775216138 -0.00864553314121045 0 -0.0201729106628243 -0.0778097982708934 -0.0518731988472623 -0.103746397694524
Stock impact report

FDA Provides Clearance to IND Application for Type 1 Diabetes Therapy SAB-142 by SAB Biotherapeutics [Yahoo! Finance]

SAB Biotherapeutics, Inc. (SABS) 
Company Research Source: Yahoo! Finance
MIAMI, May 21, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS) (the “Company” or “SAB”), today announced that the U.S. Food and Drug Administration (FDA) has provided clearance for the Company's investigational new drug (IND) application to proceed for its phase 1 clinical trial for type 1 diabetes (T1D) therapy SAB-142. SAB is a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of T1D. The IND allows for enrollment of patients with type 1 diabetes in the United States into the ongoing HUMAN trial designed to generate data enabling an upcoming Phase 2B trial. The HUMAN trial – fully HU man anti-thymocyte biologic in first-in- MAN clinical study – is a phase 1 randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intraveno Show less Read more
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