July 3, 2026 —
Kriya Therapeutics announced that it has been selected by the U.S. Food and Drug Administration to participate in the FDA PreCheck Pilot Program, a strategic initiative designed to strengthen the U.S. drug supply chain and support faster readiness for critical medicines.
The FDA selected Kriya through a competitive process evaluating the company’s capabilities and plans for its new commercial facility in Research Triangle Park, North Carolina. The facility is expected to support Kriya’s pipeline of AAV-based gene therapy products, which are currently being evaluated in clinical trials for chronic diseases.
The FDA PreCheck Pilot Program enables earlier engagement between the FDA and companies developing new facilities. Through ongoing communication and regulatory feedback during facility design, construction, and operational readiness, the program aims to improve regulatory predictability, streamline review timelines, reduce time to market, and expand U.S.-based capacity for important medicines.
Kriya is developing durable medicines for chronic diseases using an integrated platform that combines AAV vector engineering, process development, analytical testing, and GMP capabilities. The company’s infrastructure is designed to support clinical and commercial-stage development while incorporating automation, digital technologies, and data-driven optimization to improve quality, scalability, and efficiency.
A key component of Kriya’s platform is HOPSON™, the company’s proprietary structured data system. HOPSON contains more than 80 million datapoints generated from Kriya’s internal work since the company’s founding in 2019, supporting process understanding, optimization, and consistency.
Kriya’s selection reflects the growing importance of early regulatory alignment as AAV-based therapies move from clinical development toward potential commercialization. For genetic medicines intended to treat chronic diseases, scalable infrastructure and predictable review pathways are critical to supporting broader patient access.
By participating in the FDA PreCheck Pilot Program, Kriya aims to work proactively with regulators as it advances its pipeline toward potential approval and commercialization. If successful, the collaboration could help support more efficient development and delivery of durable AAV-based medicines for patients with chronic diseases.
