DIFGEN PHARMACEUTICALS LLC

DifGen Pharmaceuticals Receives FDA Clearance for Single-Injection Breast Cancer Therapy DFGN-101

- The FDA has issued a "study may proceed" letter for DifGen's DFGN-101, an intramuscular injection for advanced or metastatic breast cancer in women. - DFGN-101 is designed as a single injection, potentially reducing the treatment burden compared to the currently marketed two-injection reference product. - The development pathway does not require a clinical endpoint efficacy study, supported by CMC data and a pilot PK study showing comparable profile to the reference product. - DifGen will proceed with preclinical toxicology studies in rat and rabbit models and a Phase 1 pharmacokinetic study.