Nanobiotix announces FDA acceptance of NANORAY-312 study protocol amendment

Nanobiotix (NBTX) announced FDA acceptance of a protocol amendment to the ongoing pivotal NANORAY-312 study. This protocol amendment, submitted by NANORAY-312 global sponsor Johnson & Johnson (JNJ), eliminates the previously planned interim analysis and modifies the final analysis to include fewer events than originally planned and to be conducted sooner. In Nanobiotix’s view, this decision could accelerate and expand the global registration pathway for JNJ-1900 in head and neck cancer, providing the opportunity for earlier increased revenue generation for the company. Nanobiotix anticipates that the modified final analysis should readout in the same timeframe as the previously planned interim analysis. Exact timing will depend on when clinical events occur. Per the license agreement, Nanobiotix is eligible to receive hundreds of millions in aggregate payments in the next few years, subject to the achievement of remaining development and regulatory milestone events related to the first two programs evaluating JNJ-1900 in head and neck cancer and lung cancer.