BIOR

FDA Clears Biora's IND Application For BT-600 In Ulcerative Colitis Treatment; Stock Surges

(RTTNews) - Biora Therapeutics Inc. (BIOR) said that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug (IND) application for BT-600, a drug/device combination for the treatment of moderate to severe ulcerative colitis.

BIOR closed Thursday's regular trading at $1.24 up $0.03 or 2.48%. In the after-hours trade, the stock further gained $0.78 or 62.90%.

BT-600 is 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. The NaviCap device has been designed for targeted delivery directly to the colon in this application.

The company noted that the phase 1 trial of BT-600 is planned as a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate safety, pharmacokinetics and pharmacodynamics, including effects on colon tissue, in healthy volunteers receiving BT-600 with tofacitinib at 5 mg and 10 mg doses.

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