USFDAJun 3, 2026, 05:02 PM
60 Degrees Pharma plans FDA Priority Review Voucher for tafenoquine
AI Summary
60 Degrees Pharmaceuticals, Inc. announced its intention to submit an application for a Commissioner’s National Priority Review Voucher. This application is contingent on the positive outcome of interim or final analysis from its randomized, placebo-controlled trial of tafenoquine for severe babesiosis. The company aims to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) before the end of the first quarter of 2028, based on supportive trial results.
Key Highlights
- 60 Degrees Pharmaceuticals intends to apply for a Commissioner’s National Priority Review Voucher.
- The application is contingent on positive interim or final analysis of the tafenoquine clinical trial.
- The trial is randomized and placebo-controlled for patients hospitalized with severe babesiosis.
- The company aims for a New Drug Application (NDA) submission to the U.S. FDA by the end of Q1 2028.
- This disclosure informs investors about the company's current development and regulatory plans.
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