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The company said the FDA did not request additional information, adding that the review of the application for the drug AXS-05 was ongoing.
Earlier this month, Axsome said the agency had identified certain deficiencies during its review of the application for AXS-05 and warned of a potential delay in approval.
Shares of the drug developer, which are down about 74% this year as of their last close, jumped more than 37% in premarket trading on Monday.
Depression affects about 16 million American adults every year, and existing antidepressants including Eli Lilly (NYSE:LLY)’s Prozac and Pfizer Inc (NYSE:PFE)’s Zoloft are designed to increase the availability of a mood-regulating neurotransmitter called serotonin.
But a large number of patients do not respond to those therapies, which could take up to six weeks to show any effect, letting companies developing new drugs that target the treatment-resistant population.
Axsome’s AXS-05 targets several neurotransmitters including serotonin and is designed to reduce symptoms of depression in one week.
The drug succeeded in reducing symptoms of major depressive disorder in a late-stage trial in December 2019 and also showed benefits for treatment-resistant patients in a mid-stage study in 2020.
