CROSSJECT has provided an update on the EUA filing for Zepizure. Management has confirmed the filing will occur in June 2025, as previously indicated, demonstrating adherence to their timeline. This development is likely to enhance investor confidence, which had recently declined. Consequently, the market has reacted positively, although the successful launch of Zeneo is not yet fully reflected in the share price. Our target price remains unchanged at €6.76.
Crossject and its CDMO partner, Eurofins, have successfully completed the aseptic filling of all ZEPIZURE® registration batches. They expect to deliver the final manufacturing data required for the US FDA Emergency Use Authorization (EUA) submission by June 2025. Crossject has initiated the final regulatory activities for the Zepizure dossier submission under the EUA. The group has commenced manufacturing EUA batches, which are intended for the initial delivery to the “Chempack program,” supporting U.S. national preparedness against chemical threats.
Eurofins has successfully completed the production of Zepizure batches, as reported by Crossject’s management. The final assembly and packaging are proceeding as planned. The final manufacturing data will be submitted once available, with initial feedback from the FDA expected within one month of submission, acknowledging receipt of the complete dossier.
The positive development confirms that the dossier will be filed within the anticipated two-month timeframe, a significant achievement given the group’s historical challenges. The market reacted strongly, with the share price increasing by over 50%. However, it is important to note that the share price remains low, having declined by 40% over the past 12 months and 55% over two years. Previously, market confidence had waned due to delays in the group’s roadmap and inconsistent communication. However, this trend appears to be reversing.
We maintain our view that the success of Zeneo is not yet fully reflected in the share price, as indicated by our current target price of €6.76.
We will maintain our current projections for the release. However, today’s news is reassuring and indicates that the group may achieve its first sales in FY25.
