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 October 6, 2023, the Board of Directors of 60 Degrees Pharmaceuticals, Inc. (the “Company”) decided that its subsidiary, 60P Australia Pty Ltd will not re-submit its investigational new drug application for ACLR8-LR, a Phase IIB study of tafenoquine compared to placebo in patients with mild to moderate COVID-19 disease and low risk of disease progression. The Company’s decision to suspend the Phase IIB study of tafenoquine for COVID-19 was in response to recent comments received from the U.S. Food and Drug Administration.
On October 12, 2023, the Company issued a press release announcing, among other things, its decision to suspend the Phase IIB study of tafenoquine for COVID-19 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 as of October 12, 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: October 12, 2023 | By: | /s/ Geoffrey Dow |
| Name: | Geoffrey Dow | |
| Title: | Chief Executive Officer and President | |
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