The company explained that background immunosuppressant therapy performed better than anticipated based on scientific literature and physicians’ expectations. 

The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.

Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.

Public Company Edition: The German mRNA-focused company could raise up to $245m based on its proposed price range, but investor interest could drive the offering’s total higher. Also, Perceptive launches another SPAC, Regeneron sells $2bn in debt and Biohaven secures up to $950m.