Posted by Michael Wonder on 23 Oct 2025
Heidelberg Pharma’s lead ADC candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma
23 October 2025 - Heidelberg Pharma today announced that HDP-101 (pamlectabart tismanitin), the Company’s lead amanitin-based ADC candidate, has been granted fast track designation by the US FDA.
This designation was supported by nonclinical data as well as clinical data from the on-going Phase I/IIa study with HDP-101 (pamlectabart tismanitin), evaluating the safety and anti-tumour activity of the candidate in patients with relapsed or refractory multiple myeloma.
