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Unveiling further positive data for SER-109 in preventing recurrent Clostridium difficile infection at Digestive Disease Week (DDW) over the weekend, Seres Therapeutics Inc. reiterated plans to file a BLA with the U.S. FDA in mid-2022. Should the FDA accept the application and grant priority review – SER-109 has breakthrough and orphan status – the medicine could be the first microbiome-based therapy to reach the market.
New and updated preclinical and clinical data presented by biopharma firms at Digestive Disease Week 2022, including: Albireo, Cymabay, Evoke, Fractyl, Seres.
Connect Biopharma Holdings Ltd. pointed to positive secondary endpoint data and a numerical trend on the primary endpoint in favor of its S1P receptor modulator, CBP-307, in ulcerative colitis, but those results weren’t enough to keep the stock (NASDAQ:CNTB) from falling by more than 57% to close at 82 cents, as investors focused on the primary endpoint miss and the company’s decision to partner the program going forward.
