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Axsome Therapeutics Mixed Alzheimer's Disease Agitation Data Disappoints but Approvability Seen Likely, Mizuho Says
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Axsome Therapeutics Mixed Alzheimer's Disease Agitation Data Disappoints but Approvability Seen Likely, Mizuho Says
Dec 31, 2024 6:26 AM

08:53 AM EST, 12/31/2024 (MT Newswires) -- Axsome Therapeutics' ( AXSM ) mixed phase 3 outcome for AXS-05 in Alzheimer's disease agitation "disappointed," Mizuho said Tuesday, noting that a "cleaner" 2-for-2 result could have eased approvability doubts and significantly boosted the stock.

However, the firm said it remains optimistic about the US Food and Drug Administration's approval, citing "the need for a safer alternative."

On Monday, the company said it met the primary endpoint in its ACCORD-2 phase 3 trial of AXS-05, but failed to achieve statistical significance for its primary endpoint in another trial.

"We raise our probability of success/POS assumption, but as an offset, due to the mixed data, we now also lower slightly our peak market share penetration." Mizuho said in the note.

Mizuho cut its price target on Axsome stock to $122 from $124, while maintaining and outperform rating.

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