60 Degrees Pharmaceuticals Inc. filed SEC Form 8-K: Other Events
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Item 8.01 Other Events
On July 7, 2026, the Company prepared, and as of the date of this notice was preparing for submission to the U.S. Food and Drug Administration (“FDA”), a statistical analysis plan (the “SAP”) for the planned interim analysis of its randomized, placebo-controlled trial of tafenoquine in patients hospitalized with severe babesiosis (NCT0627370). The SAP states the following:
“An interim analysis will be performed at the earlier of (i) 10/30/26 or (ii) after 24 of the 33 planned patients have been randomized and followed for at least 50 days. A conditional power (CP) analysis will be performed for time to sustained clinical resolution (TTSCR) and for time to molecular cure (TTMC), each independently. If the CP is at least 80% then a log-rank test will be performed and a one-sided statistical significance of 0.02137 or less for time to TTSCR will result in early reporting of the study. If the conditional power is between 50% and 80% for either TTSCR or TTMC then a sample size reassessment will be performed. Sample size increase is capped at 33 additional patients (66 total). The results of the interim analysis will be presented to the DSMB for recommendation to the sponsor. The Sponsor and investigators will be blind to the analysis and will not know the calculated clinical power of either endpoint if the study is continued.”
As of the date of this Current Report, the Company had enrolled 23 patients in this study. The Company intends to submit an application for a Commissioner’s National Priority Review Voucher if the outcome of any interim and/or final analysis of the Company’s randomized, placebo-controlled trial of tafenoquine in patients hospitalized with severe babesiosis supports moving forward with a supplementary New Drug Application (sNDA) submission to the FDA before the end of the first quarter of 2028. The Company is providing this disclosure to inform investors regarding its current development and regulatory plans. The Company’s expectations regarding the trial, any future sNDA submission, and any potential voucher application are forward-looking statements and are subject to risks and uncertainties, including the outcome of clinical development, interactions with regulatory authorities, and other factors that could cause actual results to differ materially from those anticipated.
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause the Company’s actual results and financial position to differ materially. These risks and uncertainties include uncertainties associated with market conditions and other risks described under the heading “Risk Factors” in the Company’s SEC Filings on Form 10-K and Form 10-Q. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date hereof.
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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: July 9, 2026 | By: | /s/ Geoffrey Dow |
| Name: | Geoffrey Dow | |
| Title: | Chief Executive Officer and President | |
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