{"success":true,"data":{"pressRelease":{"id":"167567","rtpr_id":"nGNXbHqsYm-20261013","ticker":"SABS","exchange":"NASDAQ","all_tickers":["SABS","SABSW"],"title":"SAB BIO Receives FDA Fast Track Designation for SAB-142 in Stage 3 Type 1 Diabetes","author":"Globe Newswire","published_at":"2026-10-13T12:30:00.646Z","article_body":"Fast Track designation recognizes the potential of SAB-142 to address an unmet\nmedical need for people with Stage 3 type 1 diabetes\n\nMIAMI, Oct. 13, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq:\nSABS\n(https://www.globenewswire.com/Tracker?data=ZiEAsQBxNI1XlAuKLPSZRU403ECy1YRZRc2g1QlPV9Aphzgh9aOu3GL0i4k_pf9ec9UEbCO7KOFAuHe7u88rKbDrQMbqZC6ggjbbLlzr-wDi1baKBhYkRUexq6I5rk7C8lxJt-b52Q4i8EpbhXMF9mPQ7E0bXBmEjWhgypIUivHmZZFzlkSfqirDS2hneUrTA2awhkk_fyXMtBTl5fhqjyTClWmVvi_j4uB1-8Dpjn6_jKXLngboIcb9RLwnoY_N)),\na clinical-stage biopharmaceutical company developing a fully human\nanti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other\nautoimmune diseases, today announced that the U.S. Food and Drug\nAdministration (FDA) has granted Fast Track designation to SAB-142, a\npotentially disease-modifying immunotherapy being developed for the treatment\nof individuals with new-onset Stage 3 T1D.\n\nFast Track designation is intended to facilitate the development and expedite\nthe review of therapies for serious conditions where there is an unmet medical\nneed and to help bring important new treatments to patients earlier.\n\n“Receiving FDA Fast Track designation is an important regulatory milestone\nfor SAB-142 and reflects the agency’s determination that the program has the\npotential to address an unmet medical need for people diagnosed with type 1\ndiabetes,” said Samuel J. Reich, Chief Executive Officer of SAB BIO. “We\nlook forward to continuing to work closely with the FDA as we advance the\nSAB-142 clinical program. This designation represents meaningful progress\ntoward our goal of bringing SAB-142 to people living with type 1 diabetes as\nquickly as possible and transforming the meaning of a T1D diagnosis.”\n\nSAB-142 is currently being evaluated in the registrational Phase 2b SAFEGUARD\nstudy in people within 100 days of a Stage 3 T1D diagnosis, with enrollment\nexpected to be completed in Q4 2026 and topline data anticipated in 2H 2027.\nThe program is further supported by the investigator-led Phase 3 PRISE-hATG\nstudy, which is designed to evaluate SAB-142 in people with Stage 3 type 1\ndiabetes from 100 days to two years following diagnosis.\n\nAbout SAB BIO\nSAB BIO is a clinical-stage biopharmaceutical company focused on developing\nmulti-specific, high-potency, human immunoglobulin G (hIgG) to treat and\nprevent immune and autoimmune disorders. Using advanced genetic engineering\nand antibody science, SAB BIO developed a proprietary technology which holds\nthe potential to generate additional novel therapeutic candidates utilizing\nthe human immune response, without the need for human donors or convalescent\nplasma. SAB BIO has optimized genetic engineering in the development of\ntranschromosomic cattle, or Tc-Bovine, to produce hIgG. SAB BIO’s drug\ndevelopment production system is able to generate a diverse repertoire of\nspecifically targeted, high-potency, hIgGs that can address a wide range of\nserious unmet needs in human diseases. The Company’s lead candidate,\nSAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach\nthat aims to change the T1D treatment paradigm by delaying onset and\npotentially preventing disease progression of Stage 3 T1D patients. SAB-142 is\ncurrently being evaluated in newly diagnosed Stage 3 autoimmune T1D patients\nin a registrational Phase 2b clinical trial called SAFEGUARD. For more\ninformation, visit www.sab.bio.\n\nForward-Looking Statements\nCertain statements made in this press release that are not historical facts\nare forward-looking statements for purposes of the safe harbor provisions\nunder The Private Securities Litigation Reform Act of 1995. Forward-looking\nstatements generally are accompanied by words such as “believe,”\n“may,” “will,” “to be,” “estimate,” “continue,”\n“anticipate,” “intend,” “expect,” “should,” “would,”\n“plan,” “predict,” “potential,” “seem,” “seek,”\n“future,” “outlook,” and similar expressions that predict or indicate\nfuture events or trends or that are not statements of historical matters.\nThese forward-looking statements include, but are not limited to, statements\nregarding future events, including statements about the FDA Fast Track\ndesignation and potential expedited development for SAB-142 to address an area\nof serious unmet need in Stage 3 T1D; the therapeutic potential of SAB-142 to\nbe a treatment for T1D, the expectations regarding timing for enrollment and\ntopline data, and the overall development of SAB BIO’s T1D program.\n\nThese statements are based on the current expectations of SAB BIO and are not\npredictions of actual performance, and are not intended to serve as, and must\nnot be relied on, by any investor as a guarantee, prediction, definitive\nstatement, or an assurance, of fact or probability. These statements are only\ncurrent predictions or expectations, and are subject to known and unknown\nrisks, uncertainties and other factors which may be beyond our control. Actual\nevents and circumstances are difficult or impossible to predict, and these\nrisks and uncertainties may cause our or our industry’s results,\nperformance, or achievements to be materially different from those anticipated\nby these forward-looking statements. A further description of risks and\nuncertainties can be found in the sections captioned “Risk Factors” in our\nmost recent annual report on Form 10-K, subsequent quarterly reports on Form\n10-Q, as may be amended or supplemented from time to time, and other filings\nwith or submissions to, the U.S. Securities and Exchange Commission, which are\navailable at https://www.sec.gov/. Except as otherwise required by law, SAB\nBIO disclaims any intention or obligation to update or revise any\nforward-looking statements, which speak only as of the date they were made,\nwhether as a result of new information, future events, or circumstances or\notherwise.\n\nCONTACTS\n\nInvestor Relations:\nChristine Ryan\nir@sab.bio\n\nMedia:\nSheila Carlson\nmedia@sab.bio\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/6d99a771-f2c9-4d05-bf57-4f6c070df032)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXbHqsYm-20261013","title":"SAB BIO Receives FDA Fast Track Designation for SAB-142 in Stage 3 Type 1 Diabetes","author":"Globe Newswire","ticker":"SABS","created":"2026-10-13T12:30:00.646Z","tickers":["SABS","SABSW"],"exchange":"NASDAQ","article_body":"Fast Track designation recognizes the potential of SAB-142 to address an unmet\nmedical need for people with Stage 3 type 1 diabetes\n\nMIAMI, Oct. 13, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq:\nSABS\n(https://www.globenewswire.com/Tracker?data=ZiEAsQBxNI1XlAuKLPSZRU403ECy1YRZRc2g1QlPV9Aphzgh9aOu3GL0i4k_pf9ec9UEbCO7KOFAuHe7u88rKbDrQMbqZC6ggjbbLlzr-wDi1baKBhYkRUexq6I5rk7C8lxJt-b52Q4i8EpbhXMF9mPQ7E0bXBmEjWhgypIUivHmZZFzlkSfqirDS2hneUrTA2awhkk_fyXMtBTl5fhqjyTClWmVvi_j4uB1-8Dpjn6_jKXLngboIcb9RLwnoY_N)),\na clinical-stage biopharmaceutical company developing a fully human\nanti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other\nautoimmune diseases, today announced that the U.S. Food and Drug\nAdministration (FDA) has granted Fast Track designation to SAB-142, a\npotentially disease-modifying immunotherapy being developed for the treatment\nof individuals with new-onset Stage 3 T1D.\n\nFast Track designation is intended to facilitate the development and expedite\nthe review of therapies for serious conditions where there is an unmet medical\nneed and to help bring important new treatments to patients earlier.\n\n“Receiving FDA Fast Track designation is an important regulatory milestone\nfor SAB-142 and reflects the agency’s determination that the program has the\npotential to address an unmet medical need for people diagnosed with type 1\ndiabetes,” said Samuel J. Reich, Chief Executive Officer of SAB BIO. “We\nlook forward to continuing to work closely with the FDA as we advance the\nSAB-142 clinical program. This designation represents meaningful progress\ntoward our goal of bringing SAB-142 to people living with type 1 diabetes as\nquickly as possible and transforming the meaning of a T1D diagnosis.”\n\nSAB-142 is currently being evaluated in the registrational Phase 2b SAFEGUARD\nstudy in people within 100 days of a Stage 3 T1D diagnosis, with enrollment\nexpected to be completed in Q4 2026 and topline data anticipated in 2H 2027.\nThe program is further supported by the investigator-led Phase 3 PRISE-hATG\nstudy, which is designed to evaluate SAB-142 in people with Stage 3 type 1\ndiabetes from 100 days to two years following diagnosis.\n\nAbout SAB BIO\nSAB BIO is a clinical-stage biopharmaceutical company focused on developing\nmulti-specific, high-potency, human immunoglobulin G (hIgG) to treat and\nprevent immune and autoimmune disorders. Using advanced genetic engineering\nand antibody science, SAB BIO developed a proprietary technology which holds\nthe potential to generate additional novel therapeutic candidates utilizing\nthe human immune response, without the need for human donors or convalescent\nplasma. SAB BIO has optimized genetic engineering in the development of\ntranschromosomic cattle, or Tc-Bovine, to produce hIgG. SAB BIO’s drug\ndevelopment production system is able to generate a diverse repertoire of\nspecifically targeted, high-potency, hIgGs that can address a wide range of\nserious unmet needs in human diseases. The Company’s lead candidate,\nSAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach\nthat aims to change the T1D treatment paradigm by delaying onset and\npotentially preventing disease progression of Stage 3 T1D patients. SAB-142 is\ncurrently being evaluated in newly diagnosed Stage 3 autoimmune T1D patients\nin a registrational Phase 2b clinical trial called SAFEGUARD. For more\ninformation, visit www.sab.bio.\n\nForward-Looking Statements\nCertain statements made in this press release that are not historical facts\nare forward-looking statements for purposes of the safe harbor provisions\nunder The Private Securities Litigation Reform Act of 1995. Forward-looking\nstatements generally are accompanied by words such as “believe,”\n“may,” “will,” “to be,” “estimate,” “continue,”\n“anticipate,” “intend,” “expect,” “should,” “would,”\n“plan,” “predict,” “potential,” “seem,” “seek,”\n“future,” “outlook,” and similar expressions that predict or indicate\nfuture events or trends or that are not statements of historical matters.\nThese forward-looking statements include, but are not limited to, statements\nregarding future events, including statements about the FDA Fast Track\ndesignation and potential expedited development for SAB-142 to address an area\nof serious unmet need in Stage 3 T1D; the therapeutic potential of SAB-142 to\nbe a treatment for T1D, the expectations regarding timing for enrollment and\ntopline data, and the overall development of SAB BIO’s T1D program.\n\nThese statements are based on the current expectations of SAB BIO and are not\npredictions of actual performance, and are not intended to serve as, and must\nnot be relied on, by any investor as a guarantee, prediction, definitive\nstatement, or an assurance, of fact or probability. These statements are only\ncurrent predictions or expectations, and are subject to known and unknown\nrisks, uncertainties and other factors which may be beyond our control. Actual\nevents and circumstances are difficult or impossible to predict, and these\nrisks and uncertainties may cause our or our industry’s results,\nperformance, or achievements to be materially different from those anticipated\nby these forward-looking statements. A further description of risks and\nuncertainties can be found in the sections captioned “Risk Factors” in our\nmost recent annual report on Form 10-K, subsequent quarterly reports on Form\n10-Q, as may be amended or supplemented from time to time, and other filings\nwith or submissions to, the U.S. Securities and Exchange Commission, which are\navailable at https://www.sec.gov/. Except as otherwise required by law, SAB\nBIO disclaims any intention or obligation to update or revise any\nforward-looking statements, which speak only as of the date they were made,\nwhether as a result of new information, future events, or circumstances or\notherwise.\n\nCONTACTS\n\nInvestor Relations:\nChristine Ryan\nir@sab.bio\n\nMedia:\nSheila Carlson\nmedia@sab.bio\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/6d99a771-f2c9-4d05-bf57-4f6c070df032)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-13T12:30:00.693416543Z","server_sent_at_ms":1791894600693},"received_at":"2026-10-13T12:30:00.745Z","source_url":null},"analysis":{"id":"155860","press_release_id":"167567","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"SAB BIO received FDA Fast Track designation for SAB-142, its lead immunotherapy for new-onset Stage 3 type 1 diabetes.\n\nThe designation facilitates development and expedites FDA review of therapies addressing serious unmet medical needs, and reflects the agency's view that SAB-142 could be disease-modifying.\n\nSAB-142 is in the registrational Phase 2b SAFEGUARD study, with enrollment expected to complete in Q4 2026 and topline data anticipated in 2H 2027 — the key value-driving catalyst ahead.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Fast Track designation de-risks the regulatory path for SAB-142 ahead of Phase 2b SAFEGUARD topline data in 2H 2027."},"keyFigures":{"drugName":"SAB-142","phaseOfTrial":"Phase 2b","customDimensions":{"designations":"FDA Fast Track","topline_data":"2H 2027","enrollment_completion":"Q4 2026"}},"quotedText":"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","namedEntities":{"people":[{"name":"Samuel J. Reich","role":"Chief Executive Officer"}],"products":["SAB-142","hATG","Tc-Bovine"],"companies":[{"name":"SAB Biotherapeutics, Inc.","ticker":"SABS","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"FDA Fast Track designation is a positive regulatory milestone that can expedite review, but it is not an approval or binary trial result; the pivotal catalyst remains the Phase 2b SAFEGUARD topline data in 2H 2027."},"tickerRelevance":{"others":[],"primary":"SABS"},"globalImportance":30,"audienceRelevance":25,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"micro-cap-clinical-stage","binaryEvent":false,"eventGravity":"fast-track-designation","sectorWeight":"biotech-regulatory-milestone"}},"event_type":"regulatory","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":2,"narrative":"SAB BIO received FDA Fast Track designation for SAB-142, its lead immunotherapy for new-onset Stage 3 type 1 diabetes.\n\nThe designation facilitates development and expedites FDA review of therapies addressing serious unmet medical needs, and reflects the agency's view that SAB-142 could be disease-modifying.\n\nSAB-142 is in the registrational Phase 2b SAFEGUARD study, with enrollment expected to complete in Q4 2026 and topline data anticipated in 2H 2027 — the key value-driving catalyst ahead.","key_figures":{"drugName":"SAB-142","phaseOfTrial":"Phase 2b","customDimensions":{"designations":"FDA Fast Track","topline_data":"2H 2027","enrollment_completion":"Q4 2026"}},"named_entities":{"people":[{"name":"Samuel J. Reich","role":"Chief Executive Officer"}],"products":["SAB-142","hATG","Tc-Bovine"],"companies":[{"name":"SAB Biotherapeutics, Inc.","ticker":"SABS","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-13T12:30:12.332Z","global_importance":30,"audience_relevance":25,"importance_components":{"tickerTier":"micro-cap-clinical-stage","binaryEvent":false,"eventGravity":"fast-track-designation","sectorWeight":"biotech-regulatory-milestone"}},"durationMs":4949,"modelName":"glm-5.3-flashx"}}