Item 8.01 Other Events.

On September 17, 2021, Protagonist Therapeutics, Inc. (the "Company") issued a press release announcing that the Company's clinical studies for rusfertide, an investigational product candidate currently in development, have been placed on a clinical hold. A copy of the press release titled "Protagonist Therapeutics Reports FDA Clinical Hold on Rusfertide Clinical Development Program" is attached hereto as Exhibit 99.1 and incorporated by reference herein. The Company has begun to provide the FDA with the information requested, including additional information related to four cases of cancer observed to date across all rusfertide clinical trials. These four cases relate to distinct forms of cancer and were assessed to be unrelated to rusfertide due to a preexisting condition or natural disease progression.

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 8.01, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits






(d) Exhibits.



Exhibit                                   Description

  99.1       Press release, dated September 17, 2021, titled "Protagonist
           Therapeutics Reports FDA Clinical Hold on Rusfertide Clinical Development
           Program"
  104      Cover Page Interactive Data File (embedded within the Inline XBRL
           document).

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