Administrative constraints adds Moderna’s mRNA-1345 to the recently increasing number of US FDA user fee goal date misses.

Private Company Edition: Venture capital mega-rounds of $100m or more held steady in April after a slow January and February then a surge in March, but VC fundraising is down overall this year. In recent raises, Enveda series B expanded to $119m, Vedanta brought in $106.5m and Convergent raised $90m.

Private Company Edition: Pitchbook is out with an early look at its venture capital expectations for next year, showing continued interest in seed financings and fewer $100m-plus mega-rounds. Recent VC deals include a $75m series B financing for Alpha-9 Theranostics and $71.6m for A2 Biotherapeutics. 

Microbot Medical CEO Harel Gadot said a recent regulatory filing marks an important milestone in his company' efforts to bring the world’s first fully disposable endovascular robot to market.