60 Degrees Pharma Concludes Babesiosis Trial Enrollment at 30 Patients, Targets January 2027 Unblinding and FDA Pre-sNDA Meeting
SXTP sits 70% above its 52-week low of $0.84 on elevated volume (6.3× avg).
Summary
60 Degrees Pharmaceuticals concluded enrollment in its severe babesiosis trial at 30 patients after DSMB review, with unblinding and primary endpoint results expected January 2027. The company will request a pre-sNDA meeting with FDA that same month, and confirmed molecular cure in the first three expanded access patients.
Key Events · Product Development and Regulatory · SXTP
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DSMB Recommends Completing Study, Company Stops at 30 Patients
The DSMB recommended completing the originally planned 33-patient enrollment, but 60 Degrees decided to conclude at 30 patients and proceed to unblinding in January 2027. Enrolling three more patients would have delayed data until Fall 2027 due to babesiosis seasonality.
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No Safety Signals Identified
The DSMB analysis did not identify any safety issues, supporting continued development of tafenoquine for severe babesiosis.
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Expanded Access Study Shows Molecular Cure in First 3 Patients
The first three patients in the expanded access study achieved NAT-negative molecular cure. Patients 4 and 5 complete follow-up in early November 2026, with data disclosure expected then.
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Pre-sNDA Meeting Requested for January 2027
The company will request a pre-sNDA meeting with FDA in January 2027 to discuss data requirements, patient population, regulatory pathway, and post-marketing requirements for tafenoquine in babesiosis.
Analysis · SXTP · Life Sciences
The DSMB recommended completing the severe babesiosis study as planned with 33 patients, but 60 Degrees decided to stop at 30 and proceed to unblinding in January 2027. Enrolling three more patients would have delayed data by a full tick season until Fall 2027, and statistical advice indicated minimal impact on the ability to demonstrate significance. No safety signals were identified. The company also confirmed molecular cure in the first three expanded access patients and will request a pre-sNDA meeting with FDA in January 2027 to discuss an accelerated approval pathway using NAT as a surrogate endpoint. This is a pivotal moment for a company with cash only through early October 2026 — the January 2027 readout and FDA meeting are now the critical value drivers.
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At the time of this filing, SXTP was trading at $1.43 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.1M. The 52-week trading range was $0.84 to $8.62. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.