OrganaBio and RxMP Therapeutics Announce Manufacturing Partnership to Advance RMP-402 Hemostatic Drug Product
MIAMI & SANTA FE, Calif.--(BUSINESS WIRE)--OrganaBio, LLC ("OrganaBio"), a vertically integrated blood and cell products and services company delivering end-to-end solutions for cell and gene therapy developers, and RxMP Therapeutics, Inc. ("RxMP"), a late pre-clinical development stage therapeutics company developing novel therapies for the rapid control of severe hemorrhage, today announced a manufacturing partnership under which OrganaBio will serve as RxMP's contract manufacturing partner for the cGMP production of its lead product candidate, RMP-402.
Under the agreement, OrganaBio will support the technology transfer, qualification, and cGMP production of RMP-402, leveraging its integrated manufacturing infrastructure and quality management systems to advance the drug product through key development milestones. The collaboration brings together OrganaBio's capabilities in cGMP manufacturing, quality assurance, and analytical development with RxMP's proprietary hemostatic platform technology.
RMP-402 is a first-in-class hemostatic therapeutic composed of manufactured allogeneic red cell membrane particles (RMPs) — analogs of particles that circulate naturally in human blood. These RMPs are designed to rapidly stop bleeding when administered intravenously without increasing the risk of off-target clotting. RMP-402 is being developed for use in both civilian and military settings, addressing a global trauma and surgical bleeding market estimated at $12 billion dollars annually, where uncontrolled bleeding remains a leading cause of morbidity and preventable death. In 2025, RxMP reached consensus with the U.S. Food and Drug Administration ("FDA") on its proposed GMP manufacturing process for RMP-402 and entered into a Cooperative Research and Development Agreement ("CRADA") with the U.S. Department of Defense's Institute of Surgical Research to further validate the product's therapeutic potential for the treatment of combat casualties.
"OrganaBio was built to be the kind of partner that therapeutics companies need: responsive, rigorous, and deeply invested in our clients' success," said Justin Irizarry, Chief Executive Officer of OrganaBio. "We are honored that RxMP has entrusted us with the manufacturing of RMP-402. This is a product that has the potential to fundamentally change how clinicians manage life-threatening bleeding events, and we take that responsibility seriously. Our team is energized by the opportunity to apply our cGMP manufacturing capabilities and quality-first approach to help bring this therapy closer to the patients who need it most."
"Selecting the right manufacturing partner is one of the most consequential decisions a company at our stage can make, and we are confident that OrganaBio's combination of blood-products expertise and cGMP manufacturing under one quality system makes them the right partner for RxMP," said Shawna Khouri, Chief Operating Officer of RxMP Therapeutics. "Uncontrolled bleeding remains an area of critically high unmet need, and the urgency of the problem demands that we move with both speed and precision. With OrganaBio now established as our manufacturing partner, our team can sharpen its focus on advancing our regulatory strategy, completing the remaining IND-enabling studies, and deepening our collaboration with the Department of Defense, all while having full confidence that the manufacturing of RMP-402 is in capable and committed hands. This partnership is a critical enabler for RxMP as we work to bring a first-in-class hemostatic therapeutic to the patients, surgeons, and warfighters who need it most."
The partnership underscores the continued momentum of both companies as they work to address significant unmet medical needs. OrganaBio continues to expand its manufacturing and services capabilities from its Miami headquarters, while RxMP advances a robust development program for RMP-402 with strong support from both federal partners and private investors.
About OrganaBio
OrganaBio, LLC is a vertically integrated blood and cell products and services company headquartered in Miami, Florida. Through its wholly owned, FDA-registered subsidiaries, OrganaBio operates proprietary supply chains for ethically sourced human tissues and blood-derived cellular products, and delivers a comprehensive suite of cGMP manufacturing, analytical development, quality assurance, and regulatory support services. By combining upstream sourcing with downstream manufacturing and development expertise under a single quality framework, OrganaBio enables cell and gene therapy developers to accelerate the translation of novel therapeutics from bench to bedside. For more information, visit www.organabio.com.
About RxMP Therapeutics
RxMP Therapeutics, Inc. is a therapeutics company in late stage pre-clinical development advancing novel therapies for the rapid control of severe hemorrhage. Its lead product candidate, RMP-402, is a first-in-class hemostatic therapeutic inspired by naturally occurring red blood cell membrane particles and is designed to rapidly stop bleeding without increasing the risk of off-target clotting. RMP-402 is being developed for use in both civilian and military settings, addressing a global trauma and surgical bleeding market estimated at up to 12 billion dollars annually, where uncontrolled bleeding remains a leading cause of morbidity and preventable death. For more information, visit www.rxmpt.com.
This press release contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those expressed or implied in any forward-looking statements.
Contacts
OrganaBio: Dr. Carlos Carballosa, Ph.D. | carlos@organabio.com
RxMP Therapeutics: Cliff Mastricola | cliffm@rxmpt.com