regulatory
confidence high
sentiment positive
materiality 0.65
60 Degrees Pharmaceuticals receives FDA orphan drug designation for tafenoquine to treat acute babesiosis
60 DEGREES PHARMACEUTICALS, INC.
- FDA granted orphan drug designation for tafenoquine for acute babesiosis; company qualifies for market exclusivity, tax credits, and exemption from certain FDA filing fees.
- Company entered agreement with Tufts Medical Center for first clinical trial in human babesiosis patients; recruitment starts June 13, 2024, with at least 24 hospitalized patients.
- Babesiosis is transmitted by deer ticks; up to 47,600 of ~476,000 annual Lyme patients may be co-infected with Babesia.