- Trial Phase
- Approved (for malaria); Phase 2 (for babesiosis)
- Time to Market
- If babesiosis data is positive, a pre-sNDA meeting is planned for late January 2027, with potential sNDA filing in April/May 2027. FDA review could take 6-10 months standard, or 1-2 months if a priority review voucher (CNPV) is granted. Earliest potential babesiosis approval: late 2027 at best.
- Why 8/10
- The next hard, dated binary catalyst is the hospital study unblinding in January 2027 (~3 months away) for the Phase 2 babesiosis trial. This is the lead and essentially only program at a ~$3M market-cap company with going-concern risk, making it a make-or-break event for the stock. ImpactScore 8 reflects a dated binary within ~6 months on the company's lead asset that drives most of the thesis.
The binary catalyst is the hospital study unblinding in January 2027 — positive data would support an sNDA filing (potentially April/May 2027) and could drive a massive upside from the current ~$0.87/share price. Negative or inconclusive data would likely be catastrophic given the company's going-concern risk and ~$3M market cap. Watch for pre-sNDA meeting outcomes in late January/February 2027 and any CNPV (priority review voucher) decision from the FDA.
Price Chart
Executive Summary
KRINTAFEL is the brand name for tafenoquine, an FDA-approved anti-malaria drug originally developed by GSK (approved July 2018). 60 Degrees Pharmaceuticals (NASDAQ: SXTP) is repurposing tafenoquine for babesiosis, a tick-borne disease with no FDA-approved treatment. The company has 30 patients randomized in a Phase 2 hospitalized babesiosis study (NCT06207370) with blinded follow-up completing January 2027 — the next major binary catalyst. With a ~$3M market cap, going-concern risk, and this as essentially their only program, the stock is a high-risk binary bet on the babesiosis data. The drug itself is already approved and commercialized for malaria by GSK, but SXTP's value hinges entirely on label expansion into babesiosis.
How It Works
Tafenoquine is an anti-parasitic drug that kills the Plasmodium (malaria) and Babesia parasites by interfering with their ability to process heme, a byproduct of digesting red blood cells. It's a long-acting 8-aminoquinoline that can both prevent infection and clear dormant parasite stages from the liver. For babesiosis, it works similarly against the Babesia parasite that infects red blood cells.
Trial Status
Tafenoquine (as KRINTAFEL/ARAKODA) is FDA-approved for malaria prophylaxis and for radical cure of P. vivax malaria. For babesiosis (the SXTP value driver): 30 patients have been randomized in a Phase 2 double-blind, placebo-controlled hospitalized babesiosis study (NCT06207370) with 2:1 randomization. Blinded follow-up completes in early January 2027. A chronic babesiosis study (B-FREE) is also ongoing but has not yet enrolled patients meeting the primary per-protocol diagnostic criteria. Three confirmed expanded-access cures have been reported.
The Two-Sided Case
Upcoming Catalysts
- January 2027: Hospitalized babesiosis study unblinding (Phase 2 topline data readout)
- Late January 2027: Pre-sNDA meeting with FDA
- Pending: FDA decision on CNPV (priority review voucher) request submitted September 2026
- April/May 2027: Potential sNDA filing for babesiosis
- Q4 2027 or mid-2027: Potential FDA approval decision if priority review granted
Source Filing
The SecBot filing or press-release report that triggered this drug report:
60 DEGREES PHARMACEUTICALS, INC. 8-K SXTP ·Originating report