This section highlights FDA-related milestones and regulatory updates for drugs developed by SAB Biotherapeutics (SABS).
Over the past two years, SAB Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SAB and SAB-142. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SAB BIO - FDA Regulatory Timeline and Events
SAB BIO is a drug developed by SAB Biotherapeutics for the following indication: For Type 1 Diabetes Therapies.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SAB BIO
- Announced Date:
- June 20, 2024
- Indication:
- For Type 1 Diabetes Therapies
Announcement
SAB Biotherapeutics announced its new name, SAB BIO, and visual identity to more closely align with its mission to treat and prevent immune and autoimmune disorders with the use of its unique immunotherapy platform.
AI Summary
SAB Biotherapeutics has rebranded as SAB BIO, unveiling a new name, logo, and updated website. This change aligns the company’s visual identity with its mission to treat and prevent immune and autoimmune disorders using its unique immunotherapy platform. SAB BIO is focusing on developing therapies, especially for type 1 diabetes, by targeting disease progression in patients with new or recent onset stage 3 T1D. The new identity reflects the company’s strategic evolution and commitment to addressing serious unmet needs with innovative treatment approaches. By refreshing its corporate brand, SAB BIO aims to establish a stronger presence within the diabetes community and clearly showcase its vision for groundbreaking, human-based immunoglobulin treatments. The rebranding marks an important step forward as the company continues to develop its clinical program and engage with key stakeholders in the fight against autoimmune diseases.
Read Announcement
SAB-142 - FDA Regulatory Timeline and Events
SAB-142 is a drug developed by SAB Biotherapeutics for the following indication: Anti-thymocyte hpAB therapeutic.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SAB-142
- Announced Date:
- January 28, 2025
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB BIO announced positive topline data from a Phase 1 trial of SAB-142 in a single-ascending dose among healthy volunteers.
AI Summary
SAB BIO announced promising topline results from a Phase 1 trial of SAB-142, conducted in healthy volunteers using single-ascending dose levels. The study found that SAB-142 was generally well-tolerated, with none of the participants experiencing serum sickness or developing anti-drug antibodies at the target dose. This favorable safety profile supports the potential for chronic, outpatient dosing. The trial, which tested dose ranges from 0.03 mg/kg to 2.5 mg/kg, also demonstrated clear pharmacodynamic activity, indicating effective immunomodulation. These positive findings suggest that SAB-142 could play a significant role in delaying the onset or progression of type 1 diabetes. Building on these results, SAB BIO plans to move the program into Phase 2b development in 2025, potentially offering a new treatment option for individuals affected by this autoimmune condition.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- January 23, 2025
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB BIO announced that that the Company will host a Research and Development webinar on January 28, 2025 to discuss the topline data for Phase 1 clinical trial for its lead candidate, SAB-142.
AI Summary
SAB BIO announced it will host a Research and Development webinar on January 28, 2025. During the webinar, the company will share topline data from its Phase 1 clinical trial for SAB-142, its lead candidate designed to delay or prevent type 1 diabetes. Presentations will be given by SAB BIO’s management team along with renowned T1D expert Dr. Michael Haller from the University of Florida. This meeting will focus on discussing the study’s clinical milestones, including safety, tolerability, and other key data from the trial. A live question and answer session will follow the presentations, allowing participants to engage directly with the experts, and a replay will be available afterward on the SAB BIO website.
This event provides an opportunity for investors and interested parties to gain deeper insights into SAB-142’s potential to change treatment approaches for type 1 diabetes.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- September 9, 2024
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB BIO today will offer a trial update on SAB-142 during its presentation at the European Association for the Study of Diabetes (EASD) 60th Annual Meeting in Madrid. SAB's Executive Vice President and Chief Medical Officer Alexandra Kropotova, MD, MBA will present "Protecting pancreatic beta cells with multi-target immunotherapy: SAB-142."
AI Summary
SAB BIO will share new trial data on its investigational SAB‑142 at the European Association for the Study of Diabetes (EASD) 60th Annual Meeting in Madrid. During the event, Executive Vice President and Chief Medical Officer Dr. Alexandra Kropotova will present on “Protecting pancreatic beta cells with multi-target immunotherapy: SAB‑142.” This update comes as SAB‑142 successfully completes Phase 1 enrollment in healthy volunteers and moves forward to include a cohort of patients with type 1 diabetes. The trial, designed to assess the safety, tolerability, and potential disease-modifying effects of SAB‑142, has shown promising early safety results with no signs of serum sickness observed at the target dose. The presentation is expected to provide further insights into how this fully human anti‑thymocyte immunoglobulin may help preserve beta cell function and ultimately delay the progression of type 1 diabetes.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- September 4, 2024
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB BIO announced that it will present at the European Association for the Study of Diabetes 60th Annual Meeting on September 9, 2024 in Madrid. SAB's Executive Vice President and Chief Medical Officer Alexandra Kropotova, MD, MBA will present "Protecting pancreatic beta cells with multi-target, multi-epitope immunotherapy: SAB-142."
AI Summary
SAB BIO, a clinical-stage biopharmaceutical company focused on innovative immunotherapy for type 1 diabetes, announced it will present at the European Association for the Study of Diabetes (EASD) 60th Annual Meeting on September 9, 2024, in Madrid. The company’s Executive Vice President and Chief Medical Officer, Alexandra Kropotova, MD, MBA, will deliver the presentation titled “Protecting pancreatic beta cells with multi-target, multi-epitope immunotherapy: SAB-142.”
In her talk, Dr. Kropotova will discuss how SAB-142, a human anti-thymocyte immunoglobulin, is engineered to shield pancreatic beta cells—the body’s insulin producers—from immune attack. This innovative multi-target approach aims to slow disease progression and change the course of type 1 diabetes treatment. The presentation is expected to provide fresh insights into preserving beta cell function and offer potential alternatives for safer, more effective management of the disease.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- August 5, 2024
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc. announced the founding of a clinical advisory board to provide expert insight and guidance to the Company in the clinical development of SAB-142, its leading therapeutic candidate.
AI Summary
SAB Biotherapeutics, Inc. announced the creation of a clinical advisory board dedicated to guiding the clinical development of its leading therapeutic candidate, SAB‑142. SAB‑142 is a human anti‑thymocyte immunoglobulin designed to delay the onset or slow the progression of type 1 diabetes. The advisory board is made up of top global experts with deep clinical experience in type 1 diabetes therapies. Their guidance will cover strategic direction, clinical protocols, and research initiatives, ensuring the treatment’s development is both safe and reliable for long-term, life‑long dosing. By leveraging these experts’ insights, SAB aims to advance SAB‑142 through clinical trials and potentially revolutionize disease management for type 1 diabetes, providing a best‑in‑class alternative to current therapies. This strategic move underscores the company’s commitment to improving outcomes for patients with type 1 diabetes.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- May 21, 2024
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics 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.
AI Summary
SAB Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application, allowing the company to proceed with a phase 1 clinical trial of SAB-142. This therapy is aimed at treating type 1 diabetes (T1D) by delaying disease progression. The trial, known as the HUMAN study, is designed as a randomized, double-blind, placebo-controlled, single-ascending dose study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy volunteers and T1D patients.
The clearance permits U.S. enrollment in this first-in-man trial and is a significant step forward in validating SAB-142’s mechanism of action as a human anti-thymocyte immunoglobulin. SAB Biotherapeutics hopes this trial will generate crucial data for advancing to a subsequent Phase 2B study, ultimately aiming to improve the lives of those affected by type 1 diabetes.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- April 15, 2024
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc. announced their Chief Medical Officer, Dr. Alexandra Kropotova, MD, MBA disclosed that SAB has completed dosing the third cohort for SAB-142 with no observation of serum sickness thus far.
AI Summary
SAB Biotherapeutics, Inc. announced that its Chief Medical Officer, Dr. Alexandra Kropotova, MD, MBA, confirmed the company has successfully completed dosing the third cohort in its ongoing trial of SAB-142. Notably, there have been no observations of serum sickness in any of the participants dosed so far. SAB-142 is a first-in-class human anti-thymocyte immunoglobulin being developed to delay the onset and progression of type 1 diabetes. The clinical study utilizes a randomized, double-blind, placebo-controlled, single-ascending dose design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAB-142. This promising result offers important insights into the potential of SAB-142 as a safer, more effective alternative to rabbit-derived treatments, aiming to reduce adverse immune reactions while preserving insulin-producing beta cells for patients with type 1 diabetes.
Read Announcement
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