Restructuring Edition: Lykos recruited a J&J veteran to help its slimmed-down staff resubmit its MDMA-based PTSD therapy. Also, Lexicon cut its field force by 50%, or 75 jobs; Viracta cut its solid tumor program and 23% of its workforce; and Boundless Bio streamlined with moderate job cuts.

After failing in a Phase II trial in social anxiety disorder, Bionomics thinks mid-stage data for BNC210 in post-traumatic stress disorder may now position the drug as a novel therapy for PTSD.

Novel psychiatric drug has missed its Phase III efficacy endpoint in two Phase III trials, posing a potential blow to the Japanese firms' alliance plans in schizophrenia, although development in other CNS indications looks set to continue. 

The Orthopaedic and Rehabilitation Advisory Panel recommended FDA require a randomized, sham-control study design with a well-defined patient population to prove safety and effectiveness for the devices. The agency is currently considering whether to retain the preamendments device category in class III or downclassify to class II.