Biotech Ideas

[gfp927z]

>>> Axsome Therapeutics Stock Soars on Proposed FDA Labeling for Depression Drug


Barron's

By Angela Palumbo

June 27, 2022


https://www.barrons.com/articles/axsome-stock-fda-labeling-depression-drug-51656340089?siteid=yhoof2


Axsome is reviewing the proposed labeling from the FDA.


Shares of Axsome Therapeutics AXSM +39.44% were soaring Monday after the biopharmaceutical company announced some good news in an attempt to gain Food and Drug Administration approval of AXS-05, its drug for major depressive disorder.

In a filing with the Securities and Exchange Commission, Axsome (ticker: AXSM) announced that it had received proposed labeling from the FDA last Friday related to its new drug application for AXS-05.

Shares of Axsome were 36% higher on Monday to $33.69. The stock was on pace for its third best one-day percentage gain on record and its best one-day performance since December 2019, according to Dow Jones Market Data.

Back in August 2021, the FDA had informed Axsome that its review of the new drug application for AXS-05 would not be completed by the Prescription Drug User Fee Act target action date of August 22, 2021.

Shares for the biopharmaceutical company have fallen 11.8% in 2022 and have dropped 54% in the past 12 months.

Axsome said that it was reviewing the proposed labeling and will reply to the FDA to secure a final labeling agreement.

<<<



---