Biora Therapeutics, Inc. announced feedback from the United States Food and Drug Administration (FDA) on its clinical development plans for its PGN-600 program, and provided program updates. For Biora's Targeted Therapeutics Platform, which is focused on treatment of ulcerative colitis (UC), the company remains on track for an IND filing for its PGN-600 program followed by clinical trial initiation. During fourth quarter 2022, Biora continued its engagement with the FDA with a pre-IND supplemental Type C filing requesting agency feedback on its proposed PGN-600 clinical development plans, including the company's proposed approach to toxicity studies and other aspects of its clinical plan.

For Biora's Systemic Therapeutics program, the company has been transitioning from early concept to a clinical-ready device. With several of the key device upgrades implemented, the company expects to report data from preclinical studies on its next-generation device during first quarter and second quarter of 2023.