BioNTech SE (BNTX) has released an update.
BioNTech SE and DualityBio have announced FDA Fast Track designation for their new antibody-drug conjugate, BNT324/DB-1311, aimed at treating advanced prostate cancer, based on promising preliminary data from ongoing clinical trials. This milestone underscores the potential of their ADC candidate to improve outcomes for patients with metastatic castration-resistant prostate cancer, a form with limited treatment options and a low 5-year survival rate. The Fast Track status could expedite the development process and regulatory review, potentially bringing this innovative treatment to patients sooner.
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