Biora Therapeutics Submits Updated IND Application For BT-600; Update Includes Supplemental Information And Provides Additional Time To Complete Regulatory Review; Biora Anticipates Remaining On Track With Its Phase 1 Clinical Trial Execution Timeline
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Biora Therapeutics, Inc. (NASDAQ:BIOR) has submitted an updated Investigational New Drug (IND) application for BT-600 to the U.S. Food and Drug Administration (FDA). The update includes additional clarifying information and provides additional time for regulatory review. The IND application for BT-600 includes extensive manufacturing, preclinical, human device function, and toxicology data to support a first-in-human clinical trial for BT-600, a drug/device combination designed to use Biora's NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib for the treatment of moderate to severe ulcerative colitis.
October 30, 2023 | 8:57 pm
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Biora Therapeutics has submitted an updated IND application for BT-600 to the FDA. This could potentially lead to a positive impact on the company's stock as it shows progress in their drug development pipeline.
The submission of an updated IND application to the FDA is a significant step in the drug development process. This shows that Biora Therapeutics is making progress in their pipeline, which could potentially lead to a positive impact on the company's stock.
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