Common stock, $0.0001 par value per share
- Symbol
- SABS
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 8.01, 9.01 · 8-K
SAB Biotherapeutics, Inc.
SABSNASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On October 13, 2026, SAB Biotherapeutics, Inc., a Delaware corporation, issued a press release (the “Release”) announcing that the U.S. Food and Drug Administration 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 type 1 diabetes (T1D).…
Press release in this filing
SAB BIO Receives FDA Fast Track Designation for SAB-142 in Stage 3 Type 1 Diabetes →Company context
SAB BIO 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. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. SAB BIO has optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine, to produce hIgG. SAB BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can address a wide range of serious unmet needs in human diseases. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients. SAB-142 is currently being evaluated in newly diagnosed Stage 3 autoimmune T1D patients in a registrational Phase 2b clinical trial called SAFEGUARD. For more information, visit www.sab.bio.
Current securities
Recent company filings
- 4 filingSep 18, 2026
- 424B3 filingAug 21, 2026
- SCHEDULE 13G/A - filed by PERCEPTIVE ADVISORS LLC regarding SAB Biotherapeutics, Inc.Aug 14, 2026
- SCHEDULE 13G/A - filed by Caligan Partners LP regarding SAB Biotherapeutics, Inc.Aug 14, 2026
- SCHEDULE 13G/A - filed by Commodore Capital LP regarding SAB Biotherapeutics, Inc.Aug 14, 2026
Registered securities in this filing
SAB BIOTHERAPEUTICS, INC. · 8-K · Filed 2026-10-13
Warrants, each exercisable for one share of Common Stock
- Symbol
- SABSW
- Exchange
- NASDAQ
- Classification
- WARRANT
- Status
- Current
Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On October 13, 2026, SAB Biotherapeutics, Inc., a Delaware corporation, issued a press release (the “Release”) announcing that the U.S. Food and Drug Administration 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 type 1 diabetes (T1D). A copy of the Release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Filed exhibits (1)
EXHIBIT 99.1 SAB BIO Receives FDA Fast Track Designation for SAB-142 in Stage 3 Type 1 Diabetes Fast Track designation recognizes the potential of SAB-142 to address an unmet medical need for people with Stage 3 type 1 diabetes MIAMI, Oct. 13, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing a fully human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today 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. Fast Track designation is intended to facilitate the development and expedite the review of therapies for serious conditions where there is an unmet medical need and to help bring important new treatments to patients earlier. “Receiving FDA Fast Track designation is an important regulatory milestone for SAB-142 and reflects the agency’s determination that the program has the potential to address an unmet medical need for people diagnosed with type 1 diabetes,” said Samuel J. Reich, C…
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