The endpoint used in the AVATAR trial was different than the one investors had expected; management said the change was made to satisfy the US FDA.

Trofinetide could be the first approved drug for Rett patients after hitting both co-primary endpoints in a Phase III trial, but high rates of diarrhea and vomiting raise questions.

Biogen/Eisai’s aducanumab, as the first disease-modifying therapy and setting a precedent for accelerated approval, lifted the entire Alzheimer’s field.

Noteworthy news from medtech start-ups. This month we profile Ibris, which is developing prognostics to identify breast cancer patients in need of chemotherapy, and Delphinus Medical Technologies, whose platform enables 3-D full breast ultrasound.