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 –

RESEARCH TRIANGLE PARK, N.C. – June 29, 2026 – 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.”

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.

Media Contact:

Kimberly Ha
KKH Advisors
kimberly.​ha@​kkhadvisors.​com