Crossject: BARDA Adds $4.7M for Zepizure Pediatric Development
The Dijon-based laboratory, specialized in needle-free auto-injectors, announced the consolidation of its pediatric development plan for Zepizure, in agreement with BARDA and in line with FDA expectations. This milestone is accompanied by an extension of the contract term and non-dilutive additional financing.
Pediatric Development Aligned with FDA Recommendations
Crossject indicated, in a press release published on September 23, 2026, that the company and BARDA have consolidated the clinical development plan for Zepizure for the pediatric indication, in accordance with FDA recommendations. This plan follows ongoing exchanges between Crossject, the agency and the FDA on the pediatric development of the product.
Under amendment No. 4 to contract No. 75A50122C00031, BARDA is providing additional non-dilutive financing of $4.7 million to cover this plan and has extended the performance period until June 21, 2030. Total BARDA financing dedicated to Zepizure development now amounts to $48.0 million.
According to Patrick Alexandre, Chairman of the Board, "BARDA has agreed to finance the development that will make ZENEO® Midazolam available to children, and to align its timeline through 2030. This decision supports the role that ZEPIZURE® is called upon to play in preparing for emergency situations in the United States, for both adults and children."
Emergency Authorization in Adults Unchanged
Amendment No. 4 also finances a complementary validation campaign, including an extended stability study, which supports the New Drug Application (NDA) submission, as well as long-term management of American product stocks.
The company clarifies that pediatric activities are independent of the Emergency Use Authorization (EUA) request for the adult indication. The scope, content and all data in the EUA submission remain unchanged, and none of the activities financed under amendment No. 4 constitute a condition for the EUA.
Amendment No. 4 does not modify either the contractual volumes or the economic terms of the procurement. The contractual procurement of 306,000 Zeneo midazolam auto-injectors for adults and 54,000 pediatric auto-injectors, for a total amount of $60,840,000, remains unchanged and will be executed upon FDA approval. The total potential contract value is increased to over $170 million if all options are exercised.
