64Cu-SAR-bisPSMA

Newron Pharmaceuticals has received regulatory approval for its ENIGMA-TRS Phase III program evaluating Evenamide as an add-on therapy for treatment-resistant schizophrenia, with patient recruitment beginning immediately.

The FDA has granted Fast Track Designation to Clarity Pharmaceuticals' 64Cu-SAR-bisPSMA for PET imaging of prostate cancer lesions in patients with biochemical recurrence. This second Fast Track Designation strengthens the company's position in the growing US$2 billion PSMA PET diagnostics market and could accelerate the path to regulatory approval.

The phase 2 Co-PSMA trial will compare 64Cu-SAR-bisPSMA PET/CT imaging to the standard 68Ga-PSMA-11 PET/CT for detecting prostate cancer recurrence.

The FDA granted Fast Track Designation (FTD) to 64Cu-SAR-bisPSMA for PET imaging of prostate cancer lesions in patients with biochemical recurrence after definitive therapy.

Clarity Pharmaceuticals has commenced a Phase I/IIa clinical trial evaluating 64Cu-SAR-bisPSMA in patients with metastatic castration-resistant prostate cancer (mCRPC).