Risdiplam’s efficacy across two clinical trials and oral dosing made it a credible threat before its US FDA approval, but its weight-based pricing falls below Biogen’s Spinraza and Novartis’s Zolgensma. 

The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.

Sixteen applications are in line for US FDA decisions in August. Ten are novel agents.

Companies are shielded from antitrust concerns by Justice Department as they jointly prepare to manufacture whichever monoclonal-antibody-based coronavirus therapies emerge from development.