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Axsome is reviewing the proposed labeling from the FDA.
Dreamstime
Shares of
Axsome Therapeutics
had been hovering Monday after the biopharmaceutical firm introduced some excellent news in an try to achieve Food and Drug Administration approval of AXS-05, its drug for main depressive dysfunction.
In a submitting with the Securities and Exchange Commission, Axsome (ticker: AXSM) stated it had obtained proposed labeling from the FDA final Friday associated to its new drug utility for AXS-05.
Shares had been 36% increased on Monday to $33.69. The inventory was on tempo for its third greatest one-day proportion achieve on document and its greatest one-day efficiency since December 2019, in accordance with Dow Jones Market Data.
In August 2021, the FDA had knowledgeable Axsome that its evaluation of the brand new drug utility for AXS-05 wouldn’t be accomplished by the Prescription Drug User Fee Act goal motion date of Aug. 22, 2021.
Shares have fallen 11.8% this 12 months and have dropped 54% previously 12 months.
In a analysis notice, Cowen analyst Joseph Thome wrote that Monday’s disclosure is “an encouraging sign and hopefully an important step toward a potential near-term FDA approval.” He charges the inventory at Outperform with a $120 value goal.
Truist analyst Joon Lee, who charges the inventory at Buy with a $100 value goal, wrote in a analysis notice that “we anticipate finalization of AXS-05 label and approval in coming weeks.”
Of the 13 analysts polled by FactSet, 12 fee the inventory at Buy and one charges it at Hold.
Axsome stated it was reviewing the proposed labeling and would reply to the FDA to safe a ultimate labeling settlement.
Write to Angela Palumbo at angela.palumbo@dowjones.com
