What’s Next for Axsome Therapeutics After This FDA Approval

Axsome Therapeutics Inc. (NASDAQ: AXSM) shares jumped on Wednesday after the firm said it received an update from the U.S. Food and Drug Administration (FDA). Essentially, the agency granted Breakthrough Therapy designation for Axsome’s AXS-05 for the treatment of major depressive disorder (MDD).

Note that a Breakthrough Therapy designation is granted to potentially expedite development and review timelines for a promising investigational medicine.

The designation for AXS-05 in MDD was supported by the recent positive results from the Phase 2 Ascend study with 80 patients with confirmed moderate to severe MDD. In this trial, treatment with AXS-05 resulted in a substantial, rapid and statistically significant reduction in depressive symptoms as compared to the active comparator bupropion.

On the pre-specified primary endpoint, AXS-05 demonstrated a statistically significant average mean reduction from baseline in the Montgomery-Åsberg Depression Rating Scale total score over the six-week treatment period of 13.7 points, compared to 8.8 for bupropion.

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Herriot Tabuteau, M.D., CEO of Axsome, commented:

This Breakthrough Therapy designation from the FDA for AXS-05 in major depressive disorder exemplifies Axsome’s commitment to developing novel medicines that have the potential to significantly improve the lives of patients living with serious CNS disorders. There is a significant unmet medical need for new and mechanistically differentiated treatments for depression. We look forward to working closely with the FDA over the coming months to expedite the development of AXS-05 for the treatment of major depressive disorder.

Shares of Axsome were last seen up about 9% at $15.60, in a 52-week range of $1.94 to $16.80. The consensus price target is $24.75.

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