In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.

Public Company Edition: Roivant’s deal sets its market cap at $7.3bn. Beyond the Werewolf and Vaccitech offerings, more drug developers are slated to go public during the first week of May. And in follow-on offerings, COMPASS Pathways raises $144m and Aldeyra brings in $125m.

Public Company Edition: Mergers with special purpose acquisition corporations may be heating up, but in addition to the Surrozen and Tango SPAC deals Recursion and Biomea launched initial public offerings. Also, Organon sells $5.6bn worth of notes to fund spinout from Merck & Co.

Private Company Edition: The allogeneic cell therapy developer founded by former Juno execs launched in January 2019 without disclosing its initial funding. Other recent venture capital mega-rounds include $192m for Orca, $170m for C4, $118m for Shattuck and $102m for GreenLight.