FDA reversals leave investors worrying about the fates of other experimental drugs - CNBC

A recent string of FDA rejections has prompted investors to re-evaluate regulatory risk across experimental therapies; reporting that the White House intervened to give one drug another chance raises further concerns about political influence on approvals. While scientific progress and promising candidates still bolster confidence, the combination of regulatory reversals and apparent political intervention increases unpredictability. The robust late-stage result from the Akeso/Summit lung cancer trial may help reassure some investors by demonstrating clear clinical benefit, but approval uncertainty and commercial risks for novel modalities remain elevated.