Axsome Therapeutics reported a net loss of $29.2 million, or $(0.78) per share, for the quarter ended December 31, 2020. Research and development expenses were $17.4 million, while general and administrative expenses were $10.4 million. The company's cash position was $183.9 million at the end of the year.
NDA submitted to the FDA for AXS-05 for the treatment of MDD.
NDA for AXS-07 for the acute treatment of migraine is expected to be submitted early in the second quarter.
Positive results announced from the COMET Phase 3 long-term trial in patients with MDD.
ACCORD study initiated, a Phase 3 trial to evaluate AXS-05 in the treatment of Alzheimer’s disease (AD) agitation.
Axsome expects operating expenses to increase year over year in 2021 to support pipeline advancement and commercial function build-out. The company believes its cash at December 31, 2020, along with the remaining committed capital, is sufficient to fund operations into at least 2024.
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