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- Axsome Therapeutics Inc's (NASDAQ:AXSM) AXS-05 substantially and statistically significantly delayed the time to relapse and prevented relapse of agitation in patients with Alzheimer's disease, compared to placebo.
- The ACCORD Phase 3 trial represented a 3.6-fold lower relapse risk than the placebo.
- AXS-05 also met the key secondary endpoint of relapse prevention based on the relapse rates during the double-blind treatment period (7.5% of AXS-05 patients vs. 25.9% of placebo patients).
- Related: Axsome's Depression Candidate Scores FDA Nod, Stock Surges To 52-High.
- A statistically significant improvement was seen with open-label AXS-05 treatment at all time points starting at Week 1, with mean reductions from baseline of 11.0 points at Week 2 and 20.6 points at Week 5.
- Both clinicians and caregivers reported rapid and substantial improvement in Alzheimer's disease agitation on global measures.
- Clinicians reported improvement in agitation in 66.3% of patients at Week 2 and 86.3% at Week 5 after treatment with AXS-05.
- Caregivers reported improvement in agitation in 67.5% of patients at Week 2 and 89.3% at Week 5 after treatment with AXS-05.
- The rates of adverse events observed in the double-blind period were 28.3% in the AXS-05 group and 22.2% in the placebo group.
- Price Action: AXSM shares are up 16.1% at $65.97 during the premarket session on the last check Monday.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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