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

But Positive Data In Treatment-Resistant Depression

Aug 10 2021

• By John Davis

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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.

major depressive disorder — • Source: Alamy

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,...

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