
BioNTech (NASDAQ:BNTX) received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its product candidate BNT211 in the third- or later-line treatment of testicular germ cell tumors.
The European regulatory grant is supported by the positive preliminary data readout from ongoing phase 1/2 study demonstrating an encouraging safety profile and early signs of anti-tumor activity in testicular cancer patients that was presented at the AACR Annual Meeting in April 2022.