ALS advocates succeed in getting the FDA to soften its stance on use of randomized, placebo-controlled trials for drug development; final guidance also encourages patient-reported outcomes.

Public Company Edition: Genmab raised $505.9m while other 17 July IPOs from Fulcrum and Mirum grossed $72m and $75m, respectively. Also, Horizon sells notes to pay down debt and Inovio reduces its workforce by 28%.

The latest drug development news and highlights from our US FDA Performance Tracker.

The Astellas-partnered drug did not reach statistical significance on any FORTITUDE-ALS endpoints, but clinically significant results over time justify a longer Phase III study that's likely to enroll ALS patients with a faster rate of disease progression.