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SABS SAB Bio

SAB Biotherapeutics Inc is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. The company's lead product candidate, SAB-142, targets autoimmune Type 1 Diabetes (T1D) with a disease-modifying t…

Assets on file: SAB-142

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Catalyst calendar

Dated catalysts for SABS, including recently decided ones.

November 2027

Nov 2027

~ Nov 2027

SABSSAB Bio

SAB-142: Phase 2 trial NCT07187531 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

March 2029

Mar 2029

Mar 1, 2029

in 852 days

SABSSAB Bio

SAB-142: Phase 3 trial NCT07670650 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

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Decision-gradeMaterialNotableMinor

Oct 13, 2026

12:36 PM

SABSSAB Bio

SAB Biotherapeutics Receives FDA Fast Track for SAB-142 in Stage 3 T1D

The FDA granted Fast Track designation to SAB-142 for new-onset Stage 3 type 1 diabetes, recognizing its potential to address an unmet medical need. This designation is intended to facilitate development and expedite review. The registrational Phase 2b SAFEGUARD trial is ongoing with enrollment completion expected in Q4 2026 and topline data in 2H 2027.

FDA designationSEC 8-K