AXS-05 Phase 3 Results for MDD (GEMINI)

Axsome Therapeutics (AXSM) is higher today after releasing phase 3 results with AXS-05 for the indication of Major Depressive Disorder or (MDD). The press release is here, AXS-05 Achieves Primary Endpoint in Gemini Phase 3. Some major points from the outstanding results are as follows.

• AXS-05 at week 6 versus placebo  p=0.002
• Rate of remission of depression week 6 versus placebo  p=0.001
• Week 1 AXS-05 versus placebo p=0.007

All scores are based on the Montgomery-Asberg Depression Rating Scale or MADRS. The phase 3 clinical trial details can be found here NCT04019704. The company will file for FDA approval in the second half of 2020 for the indication of MDD, and potentially get approved for that indication in the first half of 2021. Below is the chart of the stock that appreciated +70% today.