Adicet Bio received FDA clearance for its IND application for ADI-212 in metastatic castration-resistant prostate cancer. The company’s next step is to advance the program into clinical evaluation under an FDA-reviewed development pathway. The clearance provides a formal runway for trial initiation and reflects ongoing regulator support for novel oncology modalities as long as preclinical safety and rationale requirements are met. For biotech, IND clearances in mCRPC remain a bellwether for whether new mechanisms can secure patient access beyond established androgen-axis targeting and next-line combination regimens.