CROSSJECT and BARDA align ZEPIZURE®’s Pediatric development plan with FDA including funding through 2030
- CROSSJECT and BARDA have consolidated the clinical development plan for the pediatric indication of ZEPIZURE®, in alignment with the FDA guidance
- $4.7 million in additional, non-dilutive funding, to cover the planned activities — total BARDA funding for ZEPIZURE® development now $48.0 million
- Contract period of performance extended through June 21, 2030
- The EUA pathway for the adult indication is unaffected: the scope, content and data package of the EUA dossier remain unchanged
DIJON, France — September 23rd, 2026 – 19h00 (CEST) – CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), the global specialty pharma company developing needle-free autoinjectors for emergency situations, today announces that CROSSJECT and BARDA have consolidated the clinical development plan for the pediatric indication of ZEPIZURE®, in alignment with the FDA guidance. Under Modification 4 to contract n° 75A50122C00031, BARDA is providing $4.7 million in additional non-dilutive funding to cover this plan and has extended the period of performance through June 21, 2030. Total BARDA funding dedicated to the development of ZEPIZURE® now stands at $48.0 million.
Patrick ALEXANDRE, Chairman of the Company’s Executive Board, said:
« BARDA has agreed to fund, the development that will bring ZENEO® Midazolam to children, and to plan with us through 2030. This action supports the role ZEPIZURE® is expected to play in U.S. emergency preparedness, for adults and for children alike. Our EUA pathway is unchanged, and our teams remain entirely focused on it. »
Pediatric plan designed to align with FDA expectations
The consolidated plan follows ongoing interactions between CROSSJECT, BARDA and the FDA on the pediatric development of ZEPIZURE®. It is funded by BARDA’s additional contribution, and the period of performance has been extended accordingly. Modification 4 also funds a complementary validation campaign, including extended stability, which supports the New Drug Application (NDA), and the long-term management of the product inventory.
No impact on the EUA pathway
The pediatric activities are fully independent from the Emergency Use Authorization submission for the adult indication of ZEPIZURE®. The scope, content and data package of the EUA dossier remain unchanged, and none of the activities funded under Modification 4 is a condition of the EUA.
What Modification 4 does not change
Modification 4 does not alter the EUA pathway, the contracted volumes, or the economics of the acquisition. The contracted acquisition of 306,000 adult and 54,000 pediatric ZENEO® Midazolam autoinjectors for a total of $60,840,000, to be fulfilled upon FDA approval, is unchanged. Modification 4 increases the total potential value of the contract beyond $170 million, should all options be exercised.
Forward-Looking Statements by CROSSJECT
This press release may contain forward-looking statements. Although the Company believes that its projections are based on reasonable assumptions, any statements in this press release other than statements of historical fact regarding future events are subject to (i) change without notice, (ii) factors beyond the Company’s control, (iii) the results of clinical studies, (iv) regulatory requirements, (v) increases in production costs, (vi) market access, (vii) reimbursement, (viii) competition, and (ix) potential claims regarding its products or intellectual property. These statements may include, but are not limited to, any statements beginning with, followed by, or including words or phrases such as “objective,” “believe,” “expect,” “aim,” “intend to,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “may have,” “probably,” “should,” “could,” and other words and expressions of similar meaning or used in the negative form. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that may, in certain circumstances, result in material differences between the actual results, performance, or achievements of the Company and those anticipated or expressed explicitly or implicitly by such forward-looking statements. A list and description of these risks, uncertainties, and contingencies are included in the Company’s 2025 Annual Report. Furthermore, these forward-looking statements are valid only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Unless required by law, the Company assumes no obligation to publicly update these forward-looking statements, even if new information becomes available.
This press release was prepared in French and English. In the event of any discrepancies between the two texts, the French version shall prevail.
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