Onco-Summaries: Daily Oncology Updates at a Glance

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: “We are pleased HLD-0915 has been granted Fast Track designation by FDA for patients with mCRPC. Fast Track designation is an important step forward as we work to advance this program through clinical development and, ultimately, to bring a novel, highly selective, oral-based treatment option to patients living with this challenging disease.”