Delay Looms For Axsome Therapeutics’ Entry Into Major Depressive Disorder Market With Lead Product
But Positive Data In Treatment-Resistant Depression
Axsome Therapeutics’ lead candidate, AXS-05, was nearing the US market for major depressive disorder, but the US company is trying to find out more about deficiencies identified by US regulators; the biotech has also reported positive Phase II results in treatment-resistant depression.
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After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.
Axsome is set to file for approval in the second half of 2020.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.