India, June 11 -- Radiopharm Theranostics Limited (RADX), a clinical-stage biopharmaceutical company focused on oncology radiopharmaceuticals, announced Wednesday that the U.S. Food and Drug Administration has granted Fast Track Designation for RAD101 in brain metastases diagnostic innovation.
The company said it is advancing Phase 2 clinical trial and anticipate sharing topline results in the second half of 2025.
In the pre-market activity on the Nasdaq, Radiopharm shares were gaining around 10.4 percent to trade at $5.4900.
RAD101 is the company's novel imaging small molecule that targets fatty acid synthase or FASN, a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral...