Radiopharm Gets FDA Fast Track Designation For RAD101, To Advance Phase 2 Clinical Trial; Stock Up

(RTTNews) - 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 metastases.

RAD101 is given the Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease.

The company noted that positive data from the Imperial College of London's Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment nave patients) showed significant tumor uptake that was independent from the tumor of origin.

The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.

The company noted that the U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The trial's primary objective is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases.

Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics, said, "The FDA's Fast Track Designation for RAD101 highlights the seriousness of recurrent brain metastases as a condition and the unmet medical need for innovative products that can differentiate between tumor recurrence and radiation necrosis or pseudprogression. RAD101 represents a promising advancement in improving diagnostic precision for brain metastases, offering hope for more effective clinical decision-making in the over 300,000 patients diagnosed annually in the U.S. We are excited to advance our Phase 2 clinical trial and anticipate sharing topline results in the second half of 2025."

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