SAB Biotherapeutics receives FDA Fast Track Designation for SAB-176 influenza immunotherapy for high-risk patients

SAB Biotherapeutics, Inc.

Fast Track Designation granted for SAB-176, an investigational therapeutic for Type A and B influenza in high-risk patients, including those with antiviral-resistant strains.
FDA aligned on Phase 2b trial design evaluating safety and efficacy in high-risk patients; manufacturing approach also aligned.
SAB-176 is a fully-human polyclonal IgG antibody produced without human donors via the DiversitAb platform.
Phase 2a data showed broad cross-protection against multiple influenza strains, including non-targeted strains.
The designation enables frequent FDA interactions, priority review, and rolling review eligibility.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.