Market
How will Axsome's stock price react within a week of FDA decision on AXS-05?
2
Resolution / Starting Odds
Increase by 10% or more • 25%
Decrease by 10% or more • 25%
Increase by less than 10% • 25%
Decrease by less than 10% • 25%
Stock market data from a reliable financial platform like Bloomberg or Yahoo Finance
Story
Axsome Therapeutics Plans FDA NDA Submission for AXS-05 in Alzheimer’s Disease in 2H 2025 After Phase 3 Trials Show p=0.001
Dec 30, 2024, 12:40 PM
Axsome Therapeutics has announced plans to submit a New Drug Application (NDA) to the FDA for its Alzheimer’s disease treatment, AXS-05, in the second half of 2025. This decision follows the completion of a Phase 3 clinical program, which reportedly achieved its primary endpoint compared to placebo, with a p-value of 0.001 for time to relapse. However, the results from the ADVANCE-2 trial did not demonstrate statistical significance, although there were numerically greater improvements with AXS-05 over placebo in both primary and secondary endpoints. The mixed results from these trials have raised questions about the approvability of the data package by the FDA, but Axsome remains optimistic about moving forward.
View original story
Similar markets
Biogen stock falls >5% • 25%
Biogen stock rises >5% • 25%
Other • 25%
Biogen stock stable ±5% • 25%
Increase by less than 10% • 25%
Decrease by over 10% • 25%
Decrease by less than 10% • 25%
Increase by over 10% • 25%
Increase over 20% • 25%
Increase 0-20% • 25%
No change • 25%
Decrease • 25%
Yes • 50%
No • 50%
Increase by more than 10% • 25%
Increase by less than 10% • 25%
Decrease • 25%
No significant change • 25%
Outperforms biotech index • 25%
No significant change • 25%
Underperforms biotech index • 25%
Performs in line with biotech index • 25%
Decreases by more than 10% • 25%
Increases by more than 50% • 25%
Increases by 30-50% • 25%
Remains stable (±10%) • 25%
Yes • 50%
No • 50%
Increase by more than 20% • 25%
Increase by 10% to 20% • 25%
Increase by less than 10% • 25%
Decrease or no change • 25%
Increase by more than 10% • 25%
No increase or decrease • 25%
Increase less than 5% • 25%
Increase by 5-10% • 25%
