secwatch.observer — SEC 8-K summary
======================================

Issuer:     60 DEGREES PHARMACEUTICALS, INC. (SXTP)
CIK:        0001946563
Form:       8-K
Filed at:   2026-07-09T20:05:54+00:00
Accession:  0001213900-26-076715
Event type: other_material
Sentiment:  neutral
Materiality: 0.45
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

60 Degrees files SAP for tafenoquine babesiosis trial; interim analysis criteria set
--------------------------------------------------------------------------------

- 23 of 33 planned patients enrolled in randomized, placebo-controlled trial of tafenoquine for severe babesiosis (NCT0627370).
- Interim analysis at earlier of 10/30/26 or after 24 patients randomized and followed ≥50 days.
- Conditional power ≥80% for TTSCR with p≤0.02137 triggers early reporting; 50-80% triggers sample size reassessment (capped at 66 total).
- Company intends to apply for a National Priority Review Voucher if results support sNDA submission before Q1 2028.
- Sponsor and investigators remain blinded to interim analysis results if study continues.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1946563/000121390026076715/0001213900-26-076715-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1946563/000121390026076715/ea0297549-8k_60degrees.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-076715

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer