|
 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.
[to top of second column] |
 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.)
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