Axsome says U.S. FDA asks for no extra data for depression drug, shares surge By Reuters

0 3
© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly (Reuters) -Axsome Therapeutics Inc said on Monday the U.S. Food and Drug Administration did not ask for additional information on the company's drug to treat depression as the agency continues to review it, sending shares of the drug developer surging 44% before the bell. The regulator had set an action date of Aug. 22 to decide on the drug, but notified Axsome earlier this month of some deficiencies with its marketing application that could lead to a delay in deciding the fate of the oral pill. Analysts had expected the FDA to decline Axsome's application, with Truist Securities analyst Joon Lee saying the lack of a "complete response letter" from the FDA was positive as it implied previously identified deficiencies can be remedied. Shares in Axsome are down 74% this year through Friday's close. AXS-05
Subscribe or log in to read the rest of this content.
Leave A Reply

Your email address will not be published.