Axsome Therapeutics Inc AXSM shares, which had a rip-roaring 2019, are poised to add to the gains Monday.
Good tidings continue to flow in for this biotech, which recently reported positive results for its depression drug candidate.
Axsome's Migrane Treatment Meets Primary, Secondary Endpoints
The best-performing biotech stock of the year released top-line results from a late-stage study dubbed MOMENTUM that evaluated its AXS-07 for the acute treatment of migraine.
The results showed that the investigational asset met the two regulatory co-primary endpoints of achieving pain freedom and absence of the most bothersome symptoms, both with high statistical significance.
AXS-07 also met the key secondary endpoint of demonstrating statistically significant superiority to the active comparator rizatriptan on sustained freedom from pain relief.
AXS-07 is an oral investigational medicine with dual mechanisms of action. It consists of meloxicam and rizatriptan. It is designed to provide rapid, enhanced and consistent migraine relief, with reduced symptom recurrence.
Axsome Plans NDA Filing In Second Half Of 2020
The MOMENTUM study was conducted based on a special protocol assessment with the FDA, which deemed that if the objectives are met, the trial will support the regulatory submission.
Axsome said it plans to file an NDA in the second half of 2020.
More than 37 million Americans suffer from migraine, the company said, citing the Centers for Disease Control.
Axsome said it will submit detailed study results, including additional secondary endpoints, at upcoming medical meetings and for publication.
AXS-07 is also being evaluated in the INTERCEPT Phase 3 trial for early treatment of migraine.
Recently, the FDA approved Allergan plc's AGN ubrogepant for the same indication.
The stock was trading up 3.72% at $105.77 in Monday's premarket session.
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