The European Medicines Agency has recommended updating the vaccine product information to include heavy menstrual bleeding with both Spikevax and Comirnaty, and urticaria with Spikevax. The World Health Organization says that the Omicron BA.5 strain and all its descendent lineages continue to be dominant at global level.

Industry investors foresee continued hardship for public companies still without compelling clinical data for their assets, plus the growing influence of the US Inflation Reduction Act on biopharma strategy.

Public Company Edition: PTC will get $350m up front as part of an initial $500m commitment. Also, while Biohaven and Vaxcyte launched traditional follow-on offerings, Recursion and Agios took the private placement and royalty sale routes, while others revealed job cuts and other strategic updates. 

The biotech’s share price jumps more than two-thirds as analysts hail top-line Phase I/II data as better than expected. Vaxcyte hopes to hold Phase III planning discussions with the FDA in 2023.