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AXSM

Axsome Therapeutics

$2.97

-0.17 (-5.41%)

07:04
12/10/18
12/10
07:04
12/10/18
07:04

Axsome: IDMC recommends continuation of trial evaluating AXS-05 in AD

Axsome Therapeutics announced a positive outcome of the interim analysis for the ADVANCE-1 Phase 2/3 trial of AXS-05 in agitation associated with Alzheimer's disease An independent data monitoring committee conducted the unblinded, pre-specified interim analysis for futility. Based on the results of the analysis, the IDMC recommended continuation of the AXS-05 treatment arm. Additionally, the IDMC recommended no further randomization of subjects to the bupropion treatment arm of the study. The IDMC did not indicate that there were any safety concerns in the study. Axsome intends to follow the IDMC's recommendations. AXS-05 is a novel, oral, investigational medicine consisting of dextromethorphan and bupropion. Patients in the ADVANCE-1 trial were being randomized in a 1:1:1 ratio to treatment with AXS-05, placebo, or bupropion. The primary endpoint of the study is the change in the Cohen Mansfield Agitation Inventory for AXS-05 as compared to placebo. The single-agent bupropion arm of the study was included to compare the efficacy of AXS-05 to the bupropion component, with the goal of demonstrating the superiority of AXS-05, as required by the U.S. Food and Drug Administration's combination product rule. In accordance with the IDMC's recommendation, the study will now continue enrollment in a 1:1 ratio to only the AXS-05 and placebo arms. The ADVANCE-1 interim futility analysis was performed on the first approximately 30% of the target number of subjects.

AXSM Axsome Therapeutics
$2.97

-0.17 (-5.41%)

12/05/18
HCWC
12/05/18
NO CHANGE
Target $10
HCWC
Buy
Axsome Therapeutics approaching several catalyts, says H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju noted that management at Axsome Therapeutics expect interim data from the STRIDE-1 trial of AXS-05 in TRD, interim data from the ADVANCE-1 trial of AXS-05 in AD-associated agitation and top-line data from the Phase 2 ASCEND trial of AXS-05 in major depressive disorder, all in the fourth quarter of 2018. He believes that positive data in TRD should have favorable read-through to the MDD indication sees Axsome's pivotal migraine study with AXS-07 starting before year-end and producing top-line data in 2019. Ahead of these upcoming "key value inflection points," Selvaraju reiterated his Buy rating and $10 price target on Axsome shares.
11/15/18
CANT
11/15/18
INITIATION
Target $16
CANT
Overweight
Axsome Therapeutics initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Charles Duncan last night initiated coverage of Axsome Therapeutics with an Overweight rating and $16 price target. The analyst rolled out coverage on five Neuro-Innovator companies, focusing on "innovative technologies that can lead to breakthrough and disruptive treatments." He believes all five companies have "growth potential that exceeds current valuations, over time."
11/14/18
CANT
11/14/18
INITIATION
Target $16
CANT
Overweight
Axsome Therapeutics resumed with an Overweight at Cantor Fitzgerald
Price target $16.
10/17/18
LTCO
10/17/18
NO CHANGE
Target $34
LTCO
Buy
Axsome Therapeutics price target raised to $34 from $29 at Ladenburg
Ladenburg Thalmann analyst Matthew Kaplan raised his price target for Axsome Therapeutics to $34 after the company said it plans to initiate a Phase 2 trial of AXS-12 for the treatment of the symptoms of narcolepsy in Q4 with top-line results anticipated in the first half of 2019. The analyst notes that there are only five approved compounds for the treatment of narcolepsy and only one for the treatment of both excessive daytime sleepiness and cataplexy. Including AXS-12 added $5 per share to Kaplan's model and he reiterates a Buy rating on Axsome Therapeutics.

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