BIOR - Biora extends rally as FDA feedback supports plans for ulcerative colitis candidate
- After a more than twofold rise in the previous session, nano-cap biotech Biora Therapeutics ( NASDAQ: BIOR ) added ~29% in the pre-market trading Wednesday in a rally driven by the FDA feedback on its PGN-600 program targeted at ulcerative colitis.
- PGN-600 is designed to deliver a liquid formulation of Pfizer’s ( PFE ) JAK inhibitor tofacitinib (Xeljanz) to the colon using the company’s Drug Delivery System (DDS).
- In Q4 2022, with a pre-IND supplemental Type C filing, the company requested FDA feedback regarding its proposed PGN-600 clinical development plans.
- Following the Type C response, Biora ( BIOR ) said on Monday that the company remains on track to submit an IND filing for PGN-600 with plans for clinical trial initiation in Q2 2023 and key data readouts by Q3 2023.
- The company recently announced a 1-for-25 reverse stock split which took effect when the market opened on Jan. 03.
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Biora extends rally as FDA feedback supports plans for ulcerative colitis candidate