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CJT-L31

Undisclosed

Discovery/PreclinicalNDA 351(k)/Art 10.4

Key Facts

Indication

Undisclosed

Phase

Discovery/Preclinical

Status

NDA 351(k)/Art 10.4

Company

CROSSJECT

About CROSSJECT

Crossject's mission is to revolutionize emergency drug delivery through its needle-free ZENEO® auto-injector platform, targeting critical situations where speed and ease-of-use are paramount. Its key achievement is a $60 million firm order from the U.S. BARDA for ZEPIZURE® (midazolam) for seizure rescue, with a total contract value potentially reaching $155 million. The strategy leverages a versatile 505(b)(2) regulatory pathway to build a portfolio of emergency therapies, transitioning from an R&D entity to a commercial-stage company with a primary focus on the U.S. market.

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Therapeutic Areas

Neurology Allergy & Immunology Endocrinology Public Health Preparedness

Other Undisclosed Drugs

Drug	Company	Phase	Status
Preclinical ISAC 1	Bolt Biotherapeutics	Preclinical	Available for Partnering
Preclinical ISAC 2	Bolt Biotherapeutics	Preclinical	Available for Partnering
ART12.11	Artelo Biosciences	Preclinical	Active
Novel Vaccines	MSD	Development	Active
SLS-009	Seelos Therapeutics	Discovery	Research
Technosphere Platform (New Formulations)	MannKind	Discovery/Preclinical	Active R&D
Measovir®-based Prophylactic Vaccine (with Unither)	Oncovita	Research/Pre-clinical	Early-stage collaboration
Internal sdAb Discovery Program	NanoTag Biotechnologies	Discovery	Active
NB-701	Nerai Biosciences	Discovery	Active
Undisclosed Therapeutic Program(s)	Bright Cell	Clinical Trial (Phase unspecified)	Active
Biosimilars Pipeline	Intelligent Therapeutics	Pre-clinical/Development	Active
Proprietary Therapeutic Pipeline	Excelsior Sciences	Discovery	Active