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.

Following last week’s FDA approval of its Onyx Frontier drug eluting stent (DES), Medtronic plc released results at EuroPCR from a real-world, multicenter prospective study using its Resolute Onyx platform for percutaneous coronary interventions (PCI) in the left main artery. Rehovot, Israel-based Pi-Cardia Ltd. also released early data for patients treated with its Short Cut transcatheter device for coronary obstruction prevention.