Private Company Edition: Amylyx will use its new cash to run a Phase III trial and submit applications seeking EU and Canadian approvals of AMX0035, but US filing plans based on prior Phase II/III data are less clear. Also, three VC firms raised new funds targeting biopharma and other investments.

When the Swiss company files RBX2660 in the US later this year to reduce recurrences of Clostridioides difficile infection, it will be the first time any firm has tried to get a non-antibiotic product approved to address an infectious disease. Ferring president Per Falk tells Scrip about the 35-year journey to get to this stage and why standardization is key when it comes to microbiome-based therapy.

Public Company Edition: 2020 started with two $200m-plus initial public offerings plus five health care-focused special purpose acquisition corporations IPOs. Also, a Pfizer initiative backs three public companies, Fate’s $432m offering led recent FOPOs and Biocon Biologics receives more investment. 

Competing with several other firms to bring the first microbiome-derived therapy to market, Seres says the magnitude of its Phase III efficacy compared to placebo may enough for registrational filing.