Form 8-K

8-K — 60 DEGREES PHARMACEUTICALS, INC.

Accession: 0001213900-26-099702

Filed: 2026-09-14

Period: 2026-09-12

CIK: 0001946563

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Documents

8-K — ea0305442-8k_60degree.htm (Primary)

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8-K — CURRENT REPORT

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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): September 12, 2026

DEGREES PHARMACEUTICALS, INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-41719

32-0630186

(State or

other jurisdiction of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

1025

Connecticut Avenue NW, Suite 1000

Washington,

D.C. 20036

(Address of principal executive offices) (Zip Code)

(202)

327-5422

(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, $0.0001 par value per share

SXTP

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 (§12.02

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ☒

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 Events.

Submission

of Statement of Interest for Commissioner’s National Priority Voucher

September 12, 2026, 60 Degrees Pharmaceuticals, Inc. (the “Company” or “60P”) submitted a Statement of Interest

to the U.S. Food and Drug Administration (“FDA”) requesting a Commissioner’s National Priority Voucher (“CNPV”)

designated for an efficacy supplement to NDA 210607 for ARAKODA® (tafenoquine) for the treatment of babesiosis.

Background

on Babesiosis. Babesiosis is an expanding tick-borne parasitic infection in the United States for which there is currently no

FDA-approved therapy. The disease is particularly dangerous for immunocompromised patients, who may experience prolonged or relapsing

infection despite months of off-label antimicrobial treatment and who have substantially increased mortality. The Company is the only sponsor with an FDA authorized randomized placebo-controlled trial and an expanded access study in babesiosis.

Efficacy

Signal. Tafenoquine has produced a compelling efficacy signal in treatment-refractory babesiosis. Published case reports involving

tafenoquine added to atovaquone-based therapy report cure in approximately 83% of relapsing patients, approaching 100% when treatment

is sustained until parasite clearance. In the Company’s FDA-authorized expanded access study (NCT06478641), all three currently

evaluable patients have been cured, as confirmed using an FDA-approved RNA amplification assay.

Randomized

Controlled Trial. The Company is also conducting NCT06207370, a randomized, double-blind, placebo-controlled trial of tafenoquine

plus standard of care versus placebo plus standard of care in hospitalized babesiosis patients at five Northeastern hospitals. Enrollment

required for the prespecified interim analysis is complete, and the Data Safety Monitoring Board (“DSMB”) analysis is scheduled

for October 1, 2026.

Regulatory

Pathway and Target Submission. Depending on the outcome of the interim analysis, the Company intends to pursue either regular

approval supported by the randomized trial or accelerated approval supported by expanded-access and published evidence, with an appropriate

confirmatory study. The target supplemental New Drug Application (“sNDA”) submission is March–April 2027.

Potential

for First FDA-Approved Babesiosis Treatment. CNPV review could permit the first FDA-approved babesiosis treatment to be available

at or before the 2027 tick season. Standard review timelines would likely extend approval beyond the 2027 tick season, while priority

review could place approval near the end of that season. Earlier approval would facilitate incorporation into clinical practice, payer

coverage, hospital formularies, and prescriber awareness at a time when patients most need treatment.

Federal

Priorities and Manufacturing Commitments. This program directly advances federal priorities in drug repurposing and tick-borne

disease. The Company has also committed to manufacture more than 50% of the value of future CNPV-supported products in the United States

and to provide volume-based discounts to federal programs.

Cautionary

Note Regarding Forward-Looking Statements

This

Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended,

and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to,

statements regarding: the Company’s request for a CNPV and the potential outcome of the FDA’s review of that request; the

anticipated timing and results of the interim analysis of the Company’s randomized controlled trial (NCT06207370); the Company’s

intended regulatory pathway, including whether regular or accelerated approval will be pursued; the target timing for the sNDA submission;

the potential for tafenoquine to become the first FDA-approved treatment for babesiosis; the anticipated timing of potential FDA approval

and the availability of tafenoquine for the treatment of babesiosis relative to the 2027 tick season; and the Company’s commitments

regarding U.S. manufacturing and federal program discounts.

These

forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks, and

assumptions that are difficult to predict. Actual results may differ materially from those anticipated in these forward-looking statements

as a result of various factors, including, among others: the Company’s ability to obtain the CNPV; the outcome of the DSMB interim

analysis and the randomized controlled trial; the sufficiency of clinical data to support regulatory approval; the FDA’s acceptance

and review timeline for the sNDA; the ability to manufacture tafenoquine for commercial distribution; the availability of funding to

support clinical development, regulatory activities, and commercialization; and general market, economic, and regulatory conditions.

These and other risks are described in greater detail in the Company’s filings with the Securities and Exchange Commission, including

the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to

update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be

required by law.

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 14, 2026

/s/ Geoffrey Dow

Name:

Geoffrey Dow

Title:

Chief Executive Officer

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