---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-24-022736"
form_type: "8-K"
ticker: "SXTP"
cik: "0001946563"
company_name: "60 DEGREES PHARMACEUTICALS, INC."
filed_at: "2024-03-15T23:59:59+00:00"
generated_at: "2026-06-04T18:07:57.282034+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.25
calibrated_materiality_score: 0.25
confidence: "high"
source: SEC EDGAR
---

# FDA delays response to 60 Degrees Pharma's babesiosis trial protocol to April 2024

## Summary
- FDA communicated intention to respond to babesiosis trial protocol in April 2024, not March 2024 as anticipated.
- Company maintains preparations for June 1, 2024 start date as previously communicated.
- Protocol submission is under existing IND; FDA has no specified response timeframe.
- Tafenoquine (ARAKODA) is FDA-approved for malaria prophylaxis since 2018.

## SEC filing metadata
- accession: 0001213900-24-022736
- form_type: 8-K
- ticker: SXTP
- cik: 0001946563
- company_name: 60 DEGREES PHARMACEUTICALS, INC.
- filed_at: 2024-03-15T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.25
- calibrated_materiality_score: 0.25
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1946563/000121390024022736/0001213900-24-022736-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1946563/000121390024022736/ea0201831-8k_60degree.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-022736
- JSON: https://secwatch.observer/filing/0001213900-24-022736.json
- Plain text: https://secwatch.observer/filing/0001213900-24-022736.txt

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