Ambrx Biopharma announces FDA granted Fast Track designation to ARX517

Ambrx Biopharma announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation to Ambrx’s proprietary anti-PSMA antibody-drug conjugate, ADC, investigational therapy, ARX517, for the treatment of patients with metastatic castration-resistant prostate cancer upon progression on an androgen receptor pathway inhibitor. Daniel O’Connor, Chief Executive Officer of Ambrx added: “This Fast Track designation represents a significant milestone for Ambrx. Enabled by our expanded genetic code site-specific conjugation technology, ARX517 has the potential to be a more effective and tolerable treatment option for these patients, and we are planning to present updated preliminary data from APEX-01 at a major medical meeting this fall.”