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