June 17, 2020 / 5:06 PM / a month ago

BRIEF-Nanobiotix Says FDA Provided Feedback Necessary To Proceed With Design Of NANORAY-312

June 17 (Reuters) - Nanobiotix SA:

* NANOBIOTIX RECEIVES FEEDBACK FROM US FDA TO ADVANCE PHASE III HEAD AND NECK CANCER STUDY DESIGN AND CMC DEVELOPMENT PLAN FOR NDA

* FDA PROVIDED FEEDBACK NECESSARY TO PROCEED WITH DESIGN OF NANORAY-312, A PIVOTAL PHASE III TRIAL INVESTIGATING NBTXR3 FOR ELDERLY HEAD AND NECK CANCER PATIENTS

* FDA ALSO AGREED TO NBTXR3 CHEMISTRY, MANUFACTURING AND CONTROLS (CMC) DEVELOPMENT PLAN TO SUPPORT FUTURE NEW DRUG APPLICATION (NDA) FOR PRODUCT AND ITS USE IN NANORAY-312 PHASE III CLINICAL TRIAL

* COMPANY EXPECTS TO COMMENCE NANORAY-312 AFTER MAKING PROTOCOL REFINEMENTS AND SECURING REQUISITE FINANCING TO FUND TRIAL Source text for Eikon: Further company coverage: (Gdansk Newsroom)

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