60 Degrees Pharma Seeks FDA Priority Voucher for Babesiosis Drug, DSMB Readout Set for Oct 1
SXTP is trading near its 52-week low of $0.882 (1.9% above the low).
Summary
60 Degrees Pharmaceuticals submitted a Statement of Interest to the FDA requesting a priority voucher for tafenoquine in babesiosis, and confirmed the DSMB interim analysis for its randomized trial is set for October 1, 2026.
Key Events · Product Development and Regulatory · SXTP
-
FDA Priority Voucher Request Submitted
On September 12, 2026, the company submitted a Statement of Interest to the FDA requesting a Commissioner's National Priority Voucher for an efficacy supplement to NDA 210607 for ARAKODA (tafenoquine) in babesiosis.
-
DSMB Interim Analysis Set for October 1
Enrollment for the prespecified interim analysis of the randomized, double-blind, placebo-controlled trial (NCT06207370) is complete, and the DSMB analysis is scheduled for October 1, 2026.
-
Efficacy Signal in Treatment-Refractory Patients
Published case reports show ~83% cure in relapsing babesiosis patients when tafenoquine is added to atovaquone-based therapy; all three evaluable patients in the company's expanded access study (NCT06478641) have been cured.
-
Target sNDA Submission March-April 2027
Depending on the interim analysis outcome, the company intends to pursue regular or accelerated approval, with a target supplemental NDA submission in March-April 2027.
Analysis · SXTP · Life Sciences
The company has formally asked the FDA for a Commissioner's National Priority Voucher for tafenoquine in babesiosis — a disease with no approved therapy. The filing also confirms the DSMB interim analysis is scheduled for October 1, 2026, just over two weeks away. A positive readout could support either regular or accelerated approval, with an sNDA targeted for March-April 2027. This matters because the company has cash only through early October 2026 and trades near its 52-week low; the voucher request and imminent data readout are the key near-term value drivers.
How filings like this one have moved
In the 30 days to Oct 19, 2026, 29.4% of the 1386 measured filings Wiseek scored 7 moved their stock by 5% or more by the next session's close. The median move was -0.50%. These are measured outcomes after filings of this importance, not a forecast for this one.
Measured one observation per ticker per day, after exclusions. Current figures: Filing Impact Tracker · open dataset
At the time of this filing, SXTP was trading at $0.90 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3.2M. The 52-week trading range was $0.88 to $8.62. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.