Axsome Therapeutics (NASDAQ:
AXSM) slips
3% premarket on light volume on the heels of its
pipeline update that included a revised timeline for a data readout from a Phase 2 clinical trial,
CONCERT, evaluating AXS-12 in narcolepsy. Topline results are now expected in H2 instead of this quarter.
Topline data from the ongoing Phase 3
STRIDE-1 study of lead candidate AXS-05 in treatment-resistant major depressive disorder (MDD) should be available in H2.
A Phase 3 study assessing AXS-05 in major depressive disorder (MDD) should launch shortly. Topine data should be available in H2. If all goes well, the company plans to file a U.S. marketing application in 2020.
Topline results from the Phase 2/3
ADVANCE study evaluating AXS-05 for the treatment of agitation in Alzheimer’s patients should be available in H1 2020.
Topline data from the Phase 3
MOMENTUM trial evaluating AXS-07 for the treatment of acute treatment of migraine should be available in H2.
The company says that its current resources should be sufficient to fund operations until at least Q1 2021, adding that it does not foresee another equity financing before the Phase 3 data readouts.
