(Reuters) -Axsome Therapeutics Inc said on Monday the U.S. Food and Drug Administration (FDA) was not able to complete its review of the company’s drug to treat major depressive disorder by the target action date of Aug. 22.
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’s Prozac and Pfizer Inc’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.
(Reporting by Amruta Khandekar and Dania Nadeem in Bengaluru; Editing by Devika Syamnath and Ramakrishnan M.)
