14/08/2025 Halda's HLD-0915 received the Fast Track Designation from the US FDA for mCRPC (Ref) The US FDA granted the Fast Track designation to Halda Therapeutics' HLD-0915 (androgen receptor-targeting RIPTAC) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). A Phase 1/2 trial of HLD-0915 in mCRPC is ongoing to evaluate the safety, tolerability, PK, PD, and anti-tumor activity Christian Schade, President and CEO, Halda Therapeutics: