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SEC · EDGAR 财务披露·· 3 小时前精选AI 评分60

SAB Biotherapeutics 的 SAB-142 获 FDA 快速通道资格

SAB Biotherapeutics, Inc. (0001833214) (Filer)

AI 导读

SAB Biotherapeutics, Inc. 于2026年10月13日宣布,美国食品药品监督管理局(FDA)已授予其SAB-142快速通道资格。SAB-142是一种潜在的疾病修饰免疫疗法,用于治疗新发3期1型糖尿病患者。

推荐理由

FDA授予SAB-142快速通道资格,可能加快其在新发3期1型糖尿病治疗中的开发进程。

正文 · 原文

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 13, 2026

SAB BIOTHERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-39871

85-3899721

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

777 W 41st St

Suite 401

Miami Beach, Florida

33140

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 305 845-2813

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

Trading
Symbol(s)


Name of each exchange on which registered

Common stock, $0.0001 par value per share

SABS

The Nasdaq Stock Market LLC

Warrants, each exercisable for one share of Common Stock

SABSW

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


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.

Item 9.01 Financial Statements and Exhibits.

Exhibit Number

Description

99.1

Press Release issued by SAB Biotherapeutics, Inc. dated October 13, 2026.

104

Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

SAB Biotherapeutics, Inc.

Date:

October 13, 2026

By:

/s/ Samuel J. Reich

Samuel J. Reich
Chief Executive Officer


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