AXSM - Axsome hits snag on Alzheimer's agitation candidate as FDA wants more safety data
- The US FDA has asked Axsome Therapeutics ( NASDAQ: AXSM ) to provide additional long-term safety data and information for AXS-05, its late-stage asset for Alzheimer's disease agitation.
- The agency wrote that the company should provide placebo-controlled safety information from the ongoing ADVANCE-2 trial, and long-term safety data from at least 300 patients treated for six months and 100 patients treated for one year.
- Axsome ( AXSM ) said it would file a New Drug Application after finishing ADVANCE-2 and open-label safety extension trials. It did not provide a timeline for the NDA submission.
- Read why Seeking Alpha contributor Avisol Capital Partners recently d owngraded Axsome ( AXSM ) to hold from buy.
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Axsome hits snag on Alzheimer's agitation candidate as FDA wants more safety data