Nanobiotix: FDA Approves Amendment to NANORAY-312 Phase 3 Trial Protocol
Nanobiotix announced on Monday the FDA's acceptance of an amendment to the global Phase 3 NANORAY-312 study protocol on head and neck cancer. This amendment, submitted by Johnson & Johnson as the global sponsor, modifies the analysis framework and could accelerate the development timeline of the candidate JNJ-1900 (NBTXR3).
Modification of Final Analysis and Removal of Interim Analysis
The amendment removes the initially planned interim analysis and modifies the final analysis by reducing the number of events required for its completion. According to Nanobiotix, this change could allow the revised final analysis to be read at the same time as the initially scheduled interim analysis. The exact timing of this new analysis will depend on the occurrence of clinical events related to the study.
Financial Implications and Development Portfolio
Free · Every morning
Technical market signals, before the opening bell.
Bullish and bearish momentum, analyst changes, stocks to watch — automatically computed from Euronext data.
✓ Before 9 AM every morning✓ Euronext data✓ AI-powered analysis
You're in — subscription confirmed!
Your first edition is on its way. Check your spam folder and add us to your contacts.
An error occurred.
Indicative data. No investment advice. Unsubscribe at any time.
Gratuit · chaque matin
Ne ratez plus rien sur vos actions
La tendance derrière les cours. L'essentiel des valeurs Euronext en quelques minutes.
📈les valeurs en mouvement, sur la durée
🎯les objectifs d'analystes qui évoluent
📰les actualités qui font bouger les cours
tendance · 6 séances
✓ C'est fait, vous êtes inscrit !
Votre première édition arrive bientôt. Pensez à vérifier vos spams.
Une erreur est survenue.
CAC 40 · SBF 120 · données indicatives · aucun conseil en investissement · désinscription à tout moment.
Through its licensing agreement with Janssen Pharmaceutica NV (Johnson & Johnson), Nanobiotix is eligible to receive hundreds of millions of dollars in cumulative payments over the coming years, subject to achieving certain developmental and regulatory milestones. JNJ-1900 (NBTXR3) is a hafnium oxide nanoparticle compound administered through a single intra-tumoral injection and activated by radiotherapy. It is currently being evaluated in several solid tumors, either as a monotherapy or in combination with other treatments.
SectorSanté · Biotechnologies · Vaccins et laboratoires de recherche›Biotechnologie
Free · every morning · before 9am
Never miss a move on your stocks
The trend behind the prices · Euronext
✓ You're in! Check your spam folder.
An error occurred.
The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.
Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.
