NANOBIOTIX (NBTX), a late-stage clinical biotechnology company, announced that the FDA has accepted a protocol amendment for the ongoing pivotal NANORAY-312 study evaluating JNJ-1900 in locally advanced head and neck squamous cell cancers.
JNJ-1900 (NBTXR3) is an investigational oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumour indications as a single agent or combination therapy.
As per the new protocol amendment submitted by Johnson & Johnson, the trial and development sponsor of NANORAY-312, the interim analysis is eliminated, and the final analysis is modified to include fewer events than originally planned and is estimated to be conducted sooner.
Nanobiotix anticipates that the modified final analysis should read out in the same timeframe as the previously planned interim analysis.
NBTX has traded between $3.26 and $41.89 over the last year. The stock closed Monday's trade at $31.16, down 11.28%.
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