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Kriya Selected for FDA PreCheck Pilot ProgramKriya Therapeutics, Inc. ("Kriya"), a biotechnology company developing durable medicines for chronic diseases, today announced it has been selected by the U.S. Food and Drug Administration (FDA) to participate in the FDA PreCheck Pilot Program. The FDA selected Kriya following a competitive process evaluating the company's capabilities and commercial manufacturing facility plans. As part of the pilot, Kriya's new commercial manufacturing facility in Research Triangle Park, North Carolina, will manufacture its pipeline of AAV-based gene therapy products, currently under evaluation in clinical trials, to address chronic diseases. The program prioritizes facilities that leverage modern technologies to accelerate operational readiness, reduce time to market and expand U.S. manufacturing capacity for critical medicines. "Selection for the FDA PreCheck Pilot Program is an important recognition of our investments to build manufacturing as a core internal strategic capability," said Shankar Ramaswamy, M.D., CEO & Co-Founder, Kriya. "From day one, our vision has been to develop transformative durable medicines for chronic diseases that affect millions of Americans, and the integrated infrastructure required to manufacture them efficiently, consistently and at scale. We look forward to collaborating with the FDA through this programas we continue advancing our pipeline towards commercialization." The FDA PreCheck Pilot Program is a strategic initiative designed to strengthen domestic pharmaceutical manufacturing and enhance the resilience of the U.S. drug supply chain. The program enables the FDA to engage with companies earlier in the development of new manufacturing facilities, providing ongoing communication and regulatory feedback throughout facility design, construction and operational readiness. By streamlining the review and inspection process for participating facilities, the program aims to enhance regulatory predictability for new facilities while supporting increased U.S.-based manufacturing capacity. Kriya has built one of the industry's most advanced integrated manufacturing platforms for durable medicines, combining proprietary AAV vector engineering, process development, analytical testing and GMP manufacturing. The company's manufacturing facility is designed to support both clinical and commercial production while leveraging automation, digital technologies and data-driven optimization to improve quality, scalability and efficiency. Supporting the company's physical manufacturing infrastructure is HOPSON™, Kriya's proprietary structured data platform containing over 80 million datapoints assembled through the company's internal manufacturing runs since the company's founding in 2019. Participation in the FDA PreCheck Pilot Program reflects Kriya's continued investment in its manufacturing platform and reflects a commitment to working proactively with regulators to help bring high-quality durable medicines, if approved, to patients more efficiently and at scale. About Kriya Therapeutics® Our mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease. Kriya is a clinical-stage biopharmaceutical company developing gene therapies to address chronic diseases affecting millions of people around the world. Our pipeline includes potentially transformational medicines in multiple therapeutic areas-including in ophthalmology, metabolic disease and neurology-built on our fully-integrated proprietary manufacturing and engineering platform. For more information, visit www.kriyatx.com, and follow us on LinkedIn and X.
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