Current Report Filing (8-k)
April 13 2022 - 4:32PM
Edgar (US Regulatory)
0001377121
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0001377121
2022-04-13
2022-04-13
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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): April 13, 2022
PROTAGONIST THERAPEUTICS, INC.
(Exact name of registrant as specified
in its charter)
Delaware |
|
001-37852 |
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98-0505495 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
Protagonist Therapeutics, Inc.
7707 Gateway Blvd., Suite 140
Newark, California 94560-1160
(Address of principal executive offices,
including zip code)
(510) 474-0170
(Registrant’s telephone number, including
area code)
Not Applicable
(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, par value $0.00001 |
|
PTGX |
|
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 Information.
PN-943 Phase 2 Trial Data
Protagonist Therapeutics, Inc. (the “Company”)
expects to announce top-line data from its Phase 2 clinical trial evaluating its product candidate PN-943 for ulcerative colitis in the
first half of the second quarter of 2022.
Rusfertide Breakthrough Therapy Designation
The Company has received a letter from United
States Food and Drug Administration (the “FDA”) indicating the FDA’s intent to rescind Breakthrough Therapy Designation
for the Company’s rusfertide product candidate in polycythemia vera. The Company has submitted a meeting request to the FDA,
along with a briefing document articulating why the Company believes rusfertide continues to warrant Breakthrough Therapy Designation.
The FDA letter does not relate to the rusfertide Fast Track Designation, which remains active. Initiation of the Company’s rusfertide
Phase 3 study in polycythemia vera is underway and no changes to the development plan or timeline are anticipated at this stage. Additional
details are available in the Company’s updated corporate presentation, which is attached hereto as Exhibit 99.1.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits
The information in this report, including
the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information
contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange
Commission made by Protagonist Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation
language in such filing.
SIGNATURE
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.
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Protagonist Therapeutics, Inc. |
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Dated: April 13, 2022 |
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By: |
/s/ Dinesh V. Patel, Ph.D. |
|
Dinesh V. Patel, Ph.D. |
|
|
President and Chief
Executive Officer |
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