60 Degrees to unblind severe babesiosis trial and seek FDA pre‑sNDA meeting in January 2027
60 Degrees Pharmaceuticals will unblind its double‑blind, randomized study of tafenoquine in hospitalized severe babesiosis after enrolling 30 patients. The company plans to report primary and secondary endpoint results in January 2027 and will request a pre‑sNDA meeting with the FDA that month to discuss a potential accelerated approval pathway. The Data Safety Monitoring Board found no safety signals, and the company cites expanded‑access case data as supportive evidence.
Why it matters
The company says the January 2027 readout creates a near‑term catalyst for tafenoquine’s development and the pre‑sNDA meeting could define a regulatory route, possibly using NAT‑based molecular clearance as a surrogate endpoint. Investors will need to wait for the unblinded data to assess efficacy and for FDA feedback to gauge approval prospects.
Key facts
- 1Enrollment was concluded at 30 patients, short of the originally planned 33. tradingview.com
- 2The DSMB interim analysis was conducted on October 1, 2026 and recommended completing enrollment at 33 patients. globenewswire.com
- 3No safety signals were identified in the study. tradingview.com
- 4Primary and secondary endpoint results are expected in January 2027. tradingview.com
- 5The company will request a pre‑sNDA meeting with the FDA in January 2027 to discuss data requirements and a possible accelerated approval pathway. finance.yahoo.com
- 6Expanded‑access data showed molecular cure in the first three patients, with screening data from two more patients expected in early November 2026. globenewswire.com
Summary written by AlphAI from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.