---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-077357"
form_type: "8-K"
ticker: "SXTP"
cik: "0001946563"
company_name: "60 DEGREES PHARMACEUTICALS, INC."
filed_at: "2023-09-18T23:59:59+00:00"
generated_at: "2026-06-10T15:27:09.284902+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# 60 Degrees Pharma withdraws COVID Phase IIB IND after FDA comments; will resubmit pending feasibility

## Summary
- Withdrew IND for ACLR8-LR Phase IIB study of tafenoquine for COVID-19 due to FDA comments on study design.
- Plans to submit revised IND in Q4 2023 pending assessment of feasibility to meet FDA expectations.
- Paused start-up activities for the trial, decreasing short-term burn rate and improving cash position.
- Will continue commercialization of ARAKODA (tafenoquine) for malaria and prepare IND for babesiosis.
- Q2 2023 ARAKODA sales increased 150% YoY.

## SEC filing metadata
- accession: 0001213900-23-077357
- form_type: 8-K
- ticker: SXTP
- cik: 0001946563
- company_name: 60 DEGREES PHARMACEUTICALS, INC.
- filed_at: 2023-09-18T23:59:59+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/1946563/000121390023077357/0001213900-23-077357-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1946563/000121390023077357/ea185353-8k_60degrees.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-077357
- JSON: https://secwatch.observer/filing/0001213900-23-077357.json
- Plain text: https://secwatch.observer/filing/0001213900-23-077357.txt

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