FDA on track to approve Arcadia Biosciences' new soybean technology

FDA on track to approve Arcadia Biosciences' new soybean technology.
FDA on track to approve Arcadia Biosciences' new soybean technology.
Arcadia Biosciences Inc. and Bioceres S.A. have announced that the U.S. Food and Drug Administration (FDA) has completed its Early Food Safety Evaluation (EFSE) for Verdeca, a soybean technology joint venture between the two companies.

In specific, the FDA has granted a form of early approval for HAHB4, the plant protein at the heart of Verdeca and its valuable stress tolerance trait.

“Soybean seed products based on the HB4 stress tolerance trait are in the latter stages of development, and completion of the EFSE process is a very strong and positive signal about safety,” Arcadia Biosciences President and CEO Eric Rey said. “The core safety data used in the EFSE process will facilitate international regulatory approvals for HB4 stress-tolerant soybeans, and for the use of the HB4 trait in other crops as well.”

Argentina’s National Advisory Commission on Agricultural Biotechnology (CONABIA) and the Biotechnology Directorate from the Ministry of Agriculture, Livestock and Fisheries of Argentina had already approved Verdeca’s abiotic stress tolerance trait.

“FDA conclusions are of great significance to regulators around the globe and constitute a valuable reference for present and future submissions concerning HB4 seeds,” Bioceres S.A. CEO Federico Trucco said. “As more regulatory agencies review the safety data and gain confidence in the safety of HB4 products, we hope to be able to expedite the pending regulatory processes required for the commercial launch of the technology.”

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