US FDA's Vaccines and Related Biological Products Advisory Committee endorses Rebyota for recurrent C. difficile infection; most panelists prefer a product whose manufacturing will be regulated, even one with lingering concerns about efficacy or safety, over the current landscape.

A 2013 FDA decision to allow certain fecal microbiota transplants for C. difficile infection without an investigational new drug application hurt Rebiotix’s Phase III trial enrollment and may ultimately leave it without strong enough data for advisory committee endorsement or FDA approval.

Deal Snapshot: The companies first partnered in January 2019, with a focus on more than 20 diseases. The renewed deal will support development of additional disease models using artificial intelligence and machine learning.

The company said it would discontinue the Phase III trial of the MRSA drug for futility, leaving it with no major catalysts and an uncertain cash position.