Shares of Axsome Therapeutics Inc. (AXSM) have had a massive rally over the last two months, gaining as much as 177 percent, thanks to positive results of the Company’s phase II narcolepsy trial and phase III major depressive disorder trial, announced last December.
Axsome is a clinical-stage biopharmaceutical company developing novel medicines for the management of central nervous system disorders.
The Company has two drug candidates in phase III testing – AXS-05 for treatment-resistant depression, Alzheimer’s disease and major depressive disorder, and AXS-07 for the treatment of migraine.
During this quarter (Q1), the Company is slated to report results from two of its phase III trials, dubbed STRIDE-1 and INTERCEPT.
STRIDE-1 is a phase III trial of AXS-05 in treatment-resistant depression (TRD). The primary endpoint is the change in the Montgomery Asberg Depression Rating Scale.
Treatment-resistant depression (TRD) is defined as major depressive disorder (MDD) in adults who have not responded to at least two different antidepressant treatments. (Source: BMC Psychiatry).
Eli Lilly’s Symbyax and Janssen’s nasal spray Spravato are FDA-approved drugs for treatment-resistant depression. The treatment-resistant depression market, valued at $1.01 billion in 2018, is set to reach $1.39 billion by 2027, according to a report by Credence Research.
Another much-awaited event of the Company this quarter is the release of INTERCEPT trial results. INTERCEPT is a phase III trial evaluating AXS-07 as an early treatment of migraine.
Last December, the Company announced positive data from a phase III trial evaluating AXS-07 in patients with a history of inadequate response to prior acute migraine treatments, dubbed MOMENTUM.
While the MOMENTUM trial involved patients with a history of inadequate response to prior acute migraine treatments, in the INTERCEPT trial, patients are administered AXS-07 at the earliest sign of migraine pain.
Will STRIDE-1 and INTERCEPT trials bring a smile to investors?
AXSM has traded in a range of $7.64 to $109.94 in the last 1 year. The stock closed Friday’s trading at $91.13, down 1.58%.
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