Crossject and BARDA align ZEPIZURE paediatric plan with FDA

An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.

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A white handheld diagnostic medical device rests on a grey tray on a wooden table in a brightly lit doctor's office with a window and blurred medical equipment in the background.

Crossject has secured a fourth modification to its BARDA contract, adding $4.7 million in non-dilutive funding to support a consolidated clinical development plan for the paediatric indication of ZEPIZURE, its needle-free midazolam autoinjector for emergency seizure management. The contract period of performance has been extended to 21 June 2030, taking total BARDA funding for the programme to $48 million.

The Dijon-based company was clear that the new modification does not alter the parallel Emergency Use Authorisation pathway for the adult indication. The scope, content, and data package of the EUA dossier remain unchanged, and none of the activities funded under the new modification are a condition of the EUA submission.

What the modification covers

Beyond the paediatric development plan, Modification 4 also funds a complementary validation campaign including extended stability studies. Crossject said this work supports the eventual New Drug Application and the long-term management of product inventory. The contracted acquisition volumes remain intact: 306,000 adult and 54,000 paediatric ZENEO Midazolam autoinjectors, valued at $60.84 million, to be fulfilled upon FDA approval.

Patrick Alexandre, Chairman of the Executive Board, said the agreement demonstrated BARDA's commitment to ensuring ZEPIZURE reaches children as well as adults. "This action supports the role ZEPIZURE is expected to play in U.S. emergency preparedness, for adults and for children alike," he said. "Our EUA pathway is unchanged, and our teams remain entirely focused on it."

Should all contract options be exercised, the total potential value of the BARDA arrangement now exceeds $170 million, the company added.

Regulatory and market context

ZEPIZURE sits within the US government's broader effort to shore up medical countermeasure stockpiles, a priority that has driven sustained BARDA investment across multiple emergency-use drug classes. Midazolam is an established benzodiazepine used widely for acute seizure control, and needle-free delivery formats are of particular interest to emergency preparedness planners who must account for mass-casualty or resource-constrained scenarios where trained administration is unavailable.

The paediatric extension is a logical step: the FDA's paediatric development requirements under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act mean that sponsors seeking broad labelling or NDA approval for emergency-use products must address younger age groups. Aligning the paediatric plan with FDA guidance at this stage reduces the risk of a costly redesign later in development and signals that Crossject and BARDA are planning for a commercially viable, fully labelled product rather than a narrowly scoped EUA alone.

The needle-free autoinjector space for emergency indications is relatively specialised, with a small number of companies pursuing similar device-drug combination formats. Crossject's long-term BARDA relationship and the scale of cumulative funding lend the programme credibility that earlier-stage competitors would struggle to match. Investors will be watching the EUA submission timeline as the most immediate near-term catalyst for the Euronext-listed company.

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