Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma
- Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs
- Enables more frequent engagement with FDA and eligibility for rolling review to support expedited development and review
Ladenburg, Germany, 23 October 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that HDP-101 (INN: pamlectabart tismanitin), the Company’s lead Amanitin-based ADC candidate, has been granted Fast Track Designation by the US Food and Drug Administration (FDA).
