---
schema_version: "secwatch.filing_event.v1"
accession: "0001013762-23-003541"
form_type: "8-K"
ticker: "SXTP"
cik: "0001946563"
company_name: "60 DEGREES PHARMACEUTICALS, INC."
filed_at: "2023-10-12T23:59:59+00:00"
generated_at: "2026-06-10T01:12:21.153857+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# 60 Degrees suspends Phase IIB tafenoquine COVID-19 study; pivots to malaria and babesiosis

## Summary
- Company will not re-submit IND for Phase IIB study (ACLR8-LR) of tafenoquine in mild-to-moderate COVID-19 after FDA feedback made U.S. enrollment unfeasible.
- Shifts focus to ARAKODA (tafenoquine) commercialization for malaria prophylaxis and preparation for Phase IIA study in hospitalized babesiosis patients.
- ARAKODA sales increased 150% in Q2 2023 vs Q2 2022; plans to appoint chief commercial officer and submit pre-IND meeting request for babesiosis in Q4 2023.
- FDA advice indicated placebo-controlled study allowed only when nirmatrelvir/ritonavir is not clinically appropriate, making patient recruitment very challenging.

## SEC filing metadata
- accession: 0001013762-23-003541
- form_type: 8-K
- ticker: SXTP
- cik: 0001946563
- company_name: 60 DEGREES PHARMACEUTICALS, INC.
- filed_at: 2023-10-12T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1946563/000101376223003541/0001013762-23-003541-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1946563/000101376223003541/ea186616-8k_60degrees.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001013762-23-003541
- JSON: https://secwatch.observer/filing/0001013762-23-003541.json
- Plain text: https://secwatch.observer/filing/0001013762-23-003541.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.