UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 8.01 Other Events.
On September 12, 2023, 60P Australia Pty Ltd (“60P Australia”), a majority-owned subsidiary of 60 Degrees Pharmaceuticals, Inc. (the “Company”), withdrew its investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for ACLR8-LR, a Phase IIB study of the use of tafenoquine in treating COVID-19. The Company’s decision to withdraw the IND was in response to recent comments received from the FDA. 60P Australia is evaluating whether it is feasible to revise the trial design to meet the agency's expectations while also allowing for confirmation of the acceleration in recovery from COVID-19 symptoms suggested by an earlier study.
On September 18, 2023, the Company issued a press release announcing the withdrawal of the IND described above. The press release is filed 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.
(d) Exhibits.
The following exhibits are being filed herewith:
| Exhibit No. | Description | |
| 99.1 | Press Release of 60 Degrees Pharmaceuticals, Inc. dated September 18, 2023 | |
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document). |
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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.
| 60 DEGREES PHARMACEUTICALS, INC. | ||
| Date: September 18, 2023 | By: | /s/ Geoffrey Dow |
| Name: | Geoffrey Dow | |
| Title: | Chief Executive Officer and President | |
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