Saturday, May 18, 2019

AXS-05 and SAGE-217

Axsome and SAGE Therapeutics are in phase 3 development for two promising drugs that treat Major Depressive Disorder or MDD. Both companies have completed phase 2 clinical trials with very good results, and each have achieved the Breakthrough Therapy Designation (BTD) from the FDA. What's different from the current Selective Serotonin Reuptake Inhibitors or SSRI's, is that both AXS-05 and SAGE-217 are fast acting oral delivery drugs that show efficacy within days of treatment, compared to many weeks.
Let's see how AXS-05 and SAGE-217 compare in a side by side analysis of important facts to consider. From the file below, and from listening to company conference calls, both AXS-05 and SAGE-217 could get FDA approval and to commercialization around the same time in 2021. What stands out is that while SAGE Therapeutics currently sports an 8.49B market cap, Axsome Therapeutics just a 768M market cap. Thank you for reading.

Drug AXS-05 SAGE-217
Action NMDA GABA
phase 2  ph 2 compare ph 2 placebo
Remission wk 6    47%     45% *
BTD     √     √
Pivotal      √     √
phase 3 MDD n= 300 n= 450
Start 6/1/2019 12/1/2018
End Expected 12/31/2019 12/31/2019
Safety Data Ext n= 300 n= 600 
NDA Filing est 6/1/2020 6/1/2020
Approval est 3/1/2021 3/1/2021
Delivery-oral b.i.d. qd
Patent  2034 2034
Market Cap  768M 8.49B
                            *15 day dosing

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