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.

Incyte’s topical JAK inhibitor carries a class-wide severe safety warning and cautions against chronic use, but 52-week results could ease the way for the potential vitiligo indication.

Although ANG-3777, partnered with Vifor, missed its primary endpoint in cardiovascular surgery patients at risk for acute kidney injury, the companies will consider a path forward based on a renal events measure.

Vifor and Angion’s ANG-3777 has failed in a Phase III trial for kidney transplant patients at risk of delayed graft function less than a year after the companies sealed a $80m licencing deal for the product. As focus shifts to another rare nephrological indication, analysts express skepticism.