Delay Looms For Axsome Therapeutics’ Entry Into Major Depressive Disorder Market With Lead Product

New York, US-based biotech Axsome Therapeutics, Inc. has reported positive Phase II data for its lead compound AXS-05 in treatment-refractory depression, just as a potential regulatory setback involving deficiencies in the drug’s US filing in major depressive disorder has emerged; the company’s share price fell by 46% on 9 August after the company announced the potential setback. 

Commercialization plans for AXS-05 are already well advanced. Axsome has developed a digital platform to engage with physicians and consumers,...