US delay fells Axsome shares

It was a good try, but Axsome Therapeutics’ good news/bad news ploy failed to stop shares in the biotech falling by 41% in early trading today. The first of two Axsome statements led with the positive news that its lead project AXS-05 hit its primary endpoint in the phase 2 Merit trial for treatment-resistant depression. However, this was not enough to mitigate the news that AXS-05 would miss its August 22 PDUFA date in major depressive disorder, after the FDA said it had identified “deficiencies that preclude discussion of labelling and postmarketing requirements”. Axsome is in a difficult position because the FDA has apparently not supplied details of the deficiencies, and it probably has not helped itself by waiting several days before informing the market; the FDA letter arrived on July 30. AXS-05 had been forecast to be one of the biggest launches this year. Adding to the misery analysts at Mizuho Securities pointed out the similarities between Acadia’s label-expansion plans for Nuplazid, which were initially stalled owing to “deficiencies” but ended with formal complete response letter.

AXS-05 indications
Indication Phase
Major depressive disorder Filed
Agitation Phase 3
Treatment resistant depression Phase 2
Smoking cessation Phase 2
Source: Evaluate Pharma.

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