Genentech’s $700M North Carolina Plant and Telix’s FDA CRL Update

Genentech, a subsidiary of Roche, broke ground on a new $700 million manufacturing facility in Holly Springs, North Carolina, on August 25, 20251235.

This is Genentech’s first manufacturing facility on the U.S. East Coast, chosen for its skilled workforce, academic institutions, and proximity to a strong life sciences sector235.

The 65,000 m² (700,000 sq. ft.) plant will primarily produce next-generation metabolic medicines, including treatments for obesity234.

Construction will generate more than 1,500 jobs, with over 400 high-wage manufacturing jobs created once the facility is operational1235.

The initial investment is part of Roche’s larger $50 billion commitment to U.S. manufacturing, infrastructure, and R&D123.

The site is designed with sustainable and high-efficiency technologies and offers space for future expansion; opening is planned for 202913.

Local government and business officials highlighted the project’s significance for North Carolina’s prominence in biotech and economic growth5.

Telix received a Complete Response Letter (CRL) from the FDA for its imaging agent, indicating the agency will not approve the current application as submitted; further specific details on the CRL were not provided in the referenced results.

Sources:

1. https://www.gene.com/media/press-releases/15074/2025-08-25/genentech-and-roche-break-ground-on-stat

2. https://www.roche.com/media/releases/med-cor-2025-08-25

3. https://retinalphysician.com/news/2025/genentech-breaks-ground-on-north-carolina-plant/

4. https://www.gene.com/media/press-releases/15059/2025-05-12/roche-and-genentech-announce-new-north-c

5. https://abc11.com/post/nc-jobs-genentech-breaks-ground-new-holly-springs-facility/17644338/