Rafa Laboratories, a global leader in chemical, biological, radiological, and nuclear medical countermeasures, has bagged a landmark US deal to develop a trauma drug -- a life-saving therapy for uncontrolled bleeding.

The trauma drug is basically a novel intramuscular (IM) formulation of tranexamic acid (TXA). The deal with US Biomedical Advanced Research and Development Authority (BARDA) could be worth up to $186 million, including all option periods.

The contract, Rafa’s second major collaboration with BARDA, targets a critical unmet need: a fast, easy-to-administer treatment for hemorrhage in prehospital and mass-casualty scenarios. Uncontrolled bleeding is the leading cause of preventable death following trauma, whether on the battlefield or after accidents.

“Time is everything in hemorrhagic trauma,” said Roy Shay, Vice President of Biodefense at Rafa Laboratories. “Current IV administration of TXA is slow, complex, and requires trained personnel—luxuries often unavailable in the field. An intramuscular TXA injection, especially with an autoinjector, could be a game-changer.”

Landmark studies have shown that rapid TXA administration can significantly reduce mortality, but delivering the drug intravenously in high-stress or mass-casualty situations remains a challenge. Rafa plans to develop both the IM formulation and an autoinjector, enabling professional and nonprofessional caregivers to deliver treatment instantly and reliably.

The development program will include formulation optimization, manufacturing scale-up, preclinical and clinical trials, and a streamlined regulatory pathway aimed at FDA approval.

“Rafa has spent four decades building reliable countermeasures for acute, life-threatening conditions,” said CEO Iddo Leshem. “This contract marks a major step into acute trauma care, and we are committed to working with BARDA to bring this urgently needed therapy to patients worldwide.”