CROSSJECT Secures Additional BARDA Funding for the Progressive Developmental and FDA Authorization of the ZEPIZURE® (ZENEO® Midazolam)
Press release
CROSSJECT Secures Additional BARDA Funding for the Progressive Developmental and FDA Authorization of the ZEPIZURE® (ZENEO® Midazolam)
DIJON, France – September 22, 2025 (7.30 AM CET) – CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), the global specialty pharma company developing needle-free auto-injectors for emergency situations, today confirms an additional $11.3 million in funding awarded by the U.S. Biomedical Advanced Research and Development Authority (BARDA). This brings total contract funding for advancing the development of ZEPIZURE® (ZENEO® Midazolam) to $43.3 million. The new funds support regulatory and manufacturing activities that have advanced in refinement and accuracy during the developmental path toward the FDA Emergency Use Authorization (EUA) and NDA (New Drug Application) authorizations.
CROSSJECT and BARDA continue make important progress toward meeting the regulatory requirements for the planned upcoming EUA and NDA submissions. Notable recent advancements include validation batches manufactured and the completion of a facility audit.
As previously announced, upon the FDA approval the fulfillment of the contracted acquisition of 306,000 adult ZENEO® Midazolam and 54,000 pediatric ZENEO® Midazolam autoinjectors for a total of $60,840,000 will occur.
Patrick ALEXANDRE, CEO of CROSSJECT, commented: “We are grateful for BARDA’s continued partnership and investment which underlines the importance of ZEPIZURE® to the CHEMPACK program and the U.S. Strategic National Stockpile initiative. We are approaching key regulatory and commercial production milestones with confidence, supported by the diligence of our internal teams, manufacturing partners and the strength of our collaborations with BARDA.”
About CROSSJECT
CROSSJECT SA (Euronext: ALCJ; ) is an emerging specialty pharmaceuticals company developing medicines for emergency situations harnessing its award-winning needle-free auto-injector ZENEO® platform. CROSSJECT is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, for which it has a $60 million contract* with BARDA. The Company’s versatile ZENEO® platform is designed to enable patients or untrained caregivers to easily and instantly deliver a broad range of emergency drugs via intramuscular injection on bare skin or even through clothing. The Company’s other products in developmentmainly include solutions for allergic shocks and adrenal insufficiencies, as well as therapies and other emergency indications.
* This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50122C00031.
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