60 Degrees Pharmaceuticals updates investor deck on tafenoquine babesiosis program
60 Degrees Pharmaceuticals furnished an updated investor presentation dated October 23, 2026, under Regulation FD. The deck covers its tafenoquine program for babesiosis, including a randomized hospital study that has completed enrollment at 30 subjects and is set to unblind in January 2027, with a potential regulatory filing planned for 2027.
Key points
- Randomized hospital study enrolled 30 subjects as of October 1, 2026; blinded follow-up completes in early January 2027, followed by unblinding.
- A pre-sNDA meeting with FDA is planned for late January 2027, after the hospital study unblinds.
- A September 2026 statement of interest asked FDA for national-priority review; the presentation shows a potential sNDA filing in April or May 2027.
- Early chronic-study screening showed 2 of 9 genus-level dPCR positives and 0 of 9 B. microti NAT positives.
The filing
Written by AI on Nov 9, 2026, 11:44 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 23, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.