Kriya Selected for FDA PreCheck Pilot Program
Selection recognizes Kriya’s integrated manufacturing infrastructure, supporting the advancement of Kriya’s pipeline of AAV gene therapies towards commercialization
Kriya 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 program as we continue advancing our pipeline towards commercialization.”
