After the Aduhelm controversy, Biogen has another neurodegenerative disease drug which so far can only show efficacy against surrogate biomarkers – will the FDA be swayed again this time?

Lead candidate NYX-2925 has failed a pair of Phase IIb studies in diabetic peripheral neuropathy and now one in fibromyalgia, leaving Aptinyx’s likely last hopes in neuropsychiatric indications.

With GABA-A modulator PRAX-114 missing all endpoints in a monotherapy study, Praxis will cease development of that drug and focus on its candidates for essential tremor and epilepsy.

The companies reported positive Phase III data in postpartum depression, a market opportunity of up to half a million women in the US with a condition that remains underdiagnosed.