SAB Biotherapeutics' Drug in the FDA Approval Process
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-142. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- October 13, 2026
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAB-142, a potentially disease-modifying immunotherapy being developed for the treatment of individuals with new-onset Stage 3 T1D.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- July 7, 2026
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc announced that Breakthrough T1D has awarded a grant to Michael J. Haller, M.D., Professor and Chief of Pediatric Endocrinology at the University of Florida in support of PRISE-hATG, a clinical study evaluating SAB-142 in patients with Stage 3 T1D who are 100 days to 2 years from diagnosis. Stage 3 T1D is diagnosed when the disease has progressed to a point where insulin is required.
AI Summary
SAB Biotherapeutics said Breakthrough T1D has given a grant to Michael J. Haller, M.D., at the University of Florida to support PRISE-hATG, a clinical study of SAB-142 in people with Stage 3 type 1 diabetes. The study will enroll patients who were diagnosed 100 days to 2 years earlier and still have some beta cell function. Researchers want to see whether SAB-142 can help preserve the body’s own C-peptide production and change immune responses, which could slow the loss of insulin-making cells.
The new study expands SAB BIO’s clinical program for SAB-142 and works alongside the ongoing Phase 2b SAFEGUARD trial in newly diagnosed Stage 3 T1D patients. SAB BIO will help fund the research. Company leaders said the trial could strengthen SAB-142’s case as a disease-modifying treatment for type 1 diabetes and thanked Breakthrough T1D and Dr. Haller’s team for their support.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- May 29, 2026
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc. announced that it will present data at two congresses in June. SAB BIO will present an oral presentation at the 2026 Scientific Sessions of the American Diabetes Association® (ADA) being held June 5-8, 2026, in New Orleans, LA.
AI Summary
SAB Biotherapeutics, Inc. announced that it will present new data at two congresses in June 2026. The company said SAB BIO will give an oral presentation at the American Diabetes Association’s 2026 Scientific Sessions, which will take place June 5 to June 8, 2026, in New Orleans, Louisiana. This presentation is expected to share important scientific findings with doctors, researchers, and others attending the meeting.
The company also said the presentation materials will be posted on its website after the conference. Once available, they will stay accessible in the Presentations section for people who want to review the information later.
The announcement highlights SAB Biotherapeutics’ continued focus on presenting research to the medical community at major industry events.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- April 22, 2026
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc. today presented additional clinical and mechanistic data from the Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142 at the 21st Immunology of Diabetes Society (IDS) Congress in Brisbane, Australia.
AI Summary
SAB Biotherapeutics presented additional clinical and mechanistic data from its Phase 1 HUMAN (first‑in‑man) trial of SAB‑142 at the 21st Immunology of Diabetes Society Congress in Brisbane. All four participants with type 1 diabetes who received SAB‑142 showed preservation of C‑peptide, a marker of remaining insulin production. Three of the four met a “super responder” profile that coincided with signs of CD4+ conventional T cell (Tconv) exhaustion — a state in which disease‑driving T cells become less active. The company linked this immune change to the observed preservation of insulin production, suggesting a possible mechanism of action for SAB‑142.
Participants also showed improved glycemic control versus baseline based on continuous glucose monitoring (CGM) time‑in‑range data. These are early results from a small Phase 1 study, so larger trials will be needed to confirm safety and effectiveness. Full IDS 2026 presentation materials are available in the Presentations section of the company’s website.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- April 15, 2026
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc. announced that the Company will give an oral presentation and multiple poster presentations at the 21st Immunology of Diabetes Society (IDS) Congress being held April 20-24, 2026, in Brisbane, Australia.
AI Summary
SAB Biotherapeutics, Inc. will present new research at the 21st Immunology of Diabetes Society (IDS) Congress, April 20–24, 2026, in Brisbane, Australia. The company will deliver an oral presentation and display multiple poster presentations at the meeting, sharing updates on its immunology efforts with the scientific community.
All presentation materials will be posted in the “Presentations” section of SAB Biotherapeutics’ website at the time of each presentation and will remain accessible after the conference. This lets attendees and other interested parties review the data and slides online.
For more information, contact Investor Relations: Christine Ryan at [email protected], or Media: Sheila Carlson at [email protected].
Read Announcement- Drug:
- SAB-142
- Announced Date:
- December 17, 2025
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc. announced positive, confirmatory data from a Phase 1 trial of SAB-142 in a single- and multiple-ascending dose among healthy volunteers (n=62), including a re-dosed cohort, and T1D patients (n=6).
AI Summary
SAB Biotherapeutics reported positive Phase 1 results for SAB-142 from a randomized, double-blind single- and multiple-ascending dose study in 62 healthy volunteers (including a re-dosed cohort) and 6 type 1 diabetes (T1D) patients. The trial met its safety and pharmacodynamic goals. SAB-142 was well tolerated with no drug-related serious adverse events. There were zero cases of serum sickness (0/68) and no adverse events linked to anti-drug antibodies (0/68) at any dose, including in re-dosed volunteers. Most side effects were mild, such as Grade 1 flu-like symptoms, brief infusion-site reactions, and headache.
All treated participants experienced transient lymphopenia, a marker of target engagement, which returned to baseline within 1–3 days, including after the second dose in the re-dosed cohort. The quick recovery and lack of sustained lymphodepletion suggest SAB-142 can be safely redosed and used chronically in an outpatient setting. These data supported advancing SAB-142 into the Phase 2b SAFEGUARD trial, which is now enrolling.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- December 8, 2025
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc announced that the Company will give several oral presentations at the 2nd Asian Conference on Innovative Therapies for Diabetes Management (ATTD-Asia) being held December 9-11, 2025, in Singapore..
Read Announcement- Drug:
- SAB-142
- Announced Date:
- September 19, 2025
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc. today highlighted multiple presentations made at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) held from September 15-19, 2025.
AI Summary
SAB Biotherapeutics, Inc. highlighted its newest data at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) held September 15–19, 2025. The company delivered four oral presentations and one invited talk at an INNODIA-hosted symposium. These sessions underscored SAB-142, a fully human anti-thymocyte immunoglobulin, and shared both preclinical and Phase 1 results.
Dr. Alexandra Kropotova discussed how SAB-142 offers a multi-specific mechanism of action that achieves sustained immunomodulation without the long‐lasting lymphodepletion seen with rabbit ATG. In a randomized, double-blind Phase 1 trial, SAB-142 was well tolerated in 68 healthy volunteers and patients with established type 1 diabetes and showed potential as a best-in-class immunotherapeutic.
Eric Sandhurst, Ph.D., presented a novel pharmacokinetic assay confirming a dose-proportional and reproducible profile for SAB-142, with effects lasting through Day 120. At EASD, SAB BIO also connected with global patient advocates, principal investigators, and key opinion leaders who will participate in its Phase 2b SAFEGUARD study for new-onset Stage 3 autoimmune type 1 diabetes.
Read Announcement- Drug:
- SAB-142
- Announced Date:
- September 3, 2025
- Indication:
- Anti-thymocyte hpAB therapeutic
Announcement
SAB Biotherapeutics, Inc. announced that it will present at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) being held September 15 – 19, 2025 at the VIECON - Vienna Congress & Convention Center in Vienna, Austria.
AI Summary
At the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria, SAB Biotherapeutics will share four oral presentations and host a symposium. The event runs September 15–19, 2025, at VIECON – Vienna Congress & Convention Center.
The INNODIA-hosted “Life-Changing T1D Therapies” Symposium on September 15 features Alexandra Kropotova, MD, MBA, discussing SAB BIO’s disease-modifying approach for type 1 diabetes. Other presentations include “Immunomodulation Without Sustained Lymphodepletion: SAB-142” on September 16 by Dr. Kropotova; “Mechanism of Action of a Fully Human Anti-Thymocyte Globulin, SAB-142” on September 18 by Christoph Bausch, PhD; and two back-to-back sessions by Eric Sandhurst, PhD, on a novel pharmacokinetic assay and on specimen quality in multicenter clinical trials.
These talks highlight SAB BIO’s efforts to advance SAB-142, a fully human anti-thymocyte immunoglobulin, and to push forward innovative treatments aimed at delaying or preventing type 1 diabetes progression.
Read Announcement- 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
SAB Biotherapeutics FDA Events - Frequently Asked Questions
As of now, SAB Biotherapeutics (SABS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, SAB Biotherapeutics (SABS) has reported FDA regulatory activity for SAB-142.
The most recent FDA-related event for SAB Biotherapeutics occurred on October 13, 2026, involving SAB-142. The update was categorized as "Designation Grant," with the company reporting: "SAB Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAB-142, a potentially disease-modifying immunotherapy being developed for the treatment of individuals with new-onset Stage 3 T1D."
Currently, SAB Biotherapeutics has one therapy (SAB-142) targeting the following condition: Anti-thymocyte hpAB therapeutic.
More FDA Event Resources from MarketBeat
Companies With Recent FDA Events
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:SABS last updated on 10/13/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
Free SABS Stock Alerts