Kaléo, a Glen Allen, Virginia-based drug-delivery device and auto-injector company, announced on October 7, 2026 that it has been awarded a Project BioShield contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. The contract supports late-stage development, regulatory approval, and initial procurement of a pralidoxime chloride (2-PAM) auto-injector to treat organophosphate poisoning, including nerve agent exposure, in adults and certain pediatric populations.
“This contract award will enable Kaléo to develop and deliver critical medicines through a proven, highly reliable auto-injector platform designed to perform when every second matters,” said Michael Wells, Chief Executive Officer of Kaléo. “For more than two decades we have built deep expertise at the intersection of drugs and devices, with a focus on advancing technologies that simplify treatment delivery while maintaining the highest standards of reliability and quality. Through our continued collaboration with BARDA and ASPR, we are helping strengthen the nation’s medical countermeasure infrastructure and preparedness, helping ensure capabilities, ensuring responders have access to critical tools during chemical emergencies.”
From Development Toward Deployment
The contract is the next phase of Kaléo’s collaboration with BARDA. It follows a 2024 BARDA award supporting development of the next-generation 2-PAM auto-injector, marking a progression from product development toward potential deployment for national preparedness. The funded base award of approximately $96.1 million covers late-stage development, manufacturing validation, FDA regulatory activities, and initial procurement of 2-PAM auto-injectors for national preparedness programs. Additional options, if exercised by the government, would add $244.8 million to the contract’s overall scope and value.
Why Speed Matters
Organophosphate poisoning, including nerve agent exposure, can become life-threatening within minutes and requires rapid medical intervention. These toxic chemicals interfere with acetylcholinesterase, an enzyme essential to normal nerve signaling. Given soon after exposure, pralidoxime can restore the enzyme’s activity and help reverse the effects of poisoning. A ready-to-use, easy-to-administer auto-injector is designed to make timely treatment possible in emergencies where speed, simplicity, and reliability matter. Prompt access to 2-PAM is a key part of medical preparedness for chemical threats, and the federal CHEMPACK Program places nerve agent antidotes throughout the U.S. to enable rapid access during a chemical emergency.
Built on Auto-Injector Experience
The award builds on Kaléo’s experience developing and manufacturing auto-injector products. With millions of auto-injectors manufactured and deployed globally, the company continues to apply its drug-device expertise to improving readiness and access to life-saving therapies for patients, caregivers, healthcare professionals, and emergency responders. The project is supported with federal funds from HHS, ASPR, and BARDA under contract number 75A50126C00010.
About Kaléo
Kaléo is a drug-delivery device technology and auto-injector company. Its patented Aerio™ platform, built with Human Factors Engineering, powers its portfolio of auto-injector products as well as products under development for third parties.
