The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.

The firms unveiled positive Phase III data from their respective assets for treating the agitation seen in Alzheimer’s disease with Lundbeck’s candidate set to become first-to-market for the challenging behavioral symptom.

Rezlidhia, which was only recently licensed by Rigal from Novo Nordisk-owned Forma Therapeutics, should challenge the market dominance of Servier's Tibsovo in the IDH-1 inhibitor subset of acute myeloid leukemia patients. 

Stada has begun work on a facility in Romania into which the German giant is investing more than €50m to bolster the European supply chain.