The core expertise of a specialty pharmaceutical laboratory, like that of any industrial company, lies in its ability to manage cycles. For nearly three years, the industrial scale-up cycle has been a major focus for CROSSJECT. In this edition’s Focus, Didier Morin, Industrial Director, and Xavier Perin, Head of Development and Industrialization, provide insight into the drivers behind our steady progress and explain how our industrial impulse is being built step by step.
At the same time, another critical cycle is at the very heart of our priorities as we begin 2026: the validation process of our first drug, ZEPIZURE®. We have now entered its final stage, the regulatory phase.
While this step is mandatory for any drug, it represents a first for CROSSJECT and therefore carries particular significance. This final phase involves ongoing interactions with regulatory authorities, requiring us to address questions, provide clarification, justify our approach, and, where necessary, supplement or adjust elements of our dossier. I would like to thank our teams in France and the United States for their sustained commitment throughout this demanding process. Securing Emergency Use Authorization (EUA) from U.S. regulatory authorities will mark the starting point for commercial deliveries to BARDA.
This strategically critical cycle does not, however, absorb all of our energy. We are already looking ahead, with a strong focus on maximizing responsiveness. Together with our suppliers and subcontractors, we are maintaining operational readiness to ensure immediate execution once regulatory approval is granted. In parallel, we are preparing the protocol for the final clinical study required to transition from EUA use to full New Drug Application (NDA) approval for ZEPIZURE® in the treatment of status epilepticus.
Finally, I would like to emphasize that during this decisive phase, we benefit from a robust and committed ecosystem: dedicated industrial partners — two of whom share their experience in video testimonials — a highly valuable U.S. team supporting our integration into the American environment, and an institution, BARDA, that continually challenges and strengthens our pursuit of excellence.
Here, trust is more than a word — it is the foundation of our project’s success.
Patrick Alexandre
CEO and Founder of CROSSJECT