AXSOME THERAPEUTICS, INC.

(AXSM)
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Delayed Nasdaq  -  04:00 2022-08-12 pm EDT
46.27 USD   +2.10%
08/10Morgan Stanley Raises Axsome Therapeutics Price Target to $55 From $54, Maintains Equalweight Rating
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08/10Cantor Fitzgerald Adjusts Price Target on Axsome Therapeutics to $54 From $64, Reiterates Overweight Rating
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08/09AXSOME THERAPEUTICS, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q)
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Axsome Shares Rally Premarket on Proposed AXS-05 Labeling

06/27/2022 | 05:51am EDT

By Colin Kellaher


Shares of Axsome Therapeutics Inc. jumped more than 30% in premarket trading Monday after the biopharmaceutical company reported a positive development in its efforts to secure U.S. Food and Drug Administration approval of AXS-05 for the treatment of major depressive disorder.

In a brief filing with the U.S. Securities and Exchange Commission, the New York company said it received proposed labeling for AXS-05 from the FDA.

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

The FDA had previously set an August 2021 target action date for the application, but Axsome last year said the agency had flagged deficiencies with the application that precluded the discussion of labeling and post-marketing requirements and commitments, raising fears the agency might reject the application.

While the FDA missed the target action date, its review of Axsome's application has continued, and Axsome in April said it had agreed to post-marketing requirements and commitments proposed by the agency, and that it expected the FDA could act on its application during the second quarter.

Axsome shares, which closed Friday at $24.46, were recently changing hands at $32.49, up 32.8%, in premarket trading.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

06-27-22 0751ET

All news about AXSOME THERAPEUTICS, INC.
08/10Morgan Stanley Raises Axsome Therapeutics Price Target to $55 From $54, Maintains Equal..
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Analyst Recommendations on AXSOME THERAPEUTICS, INC.
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Financials (USD)
Sales 2022 54,2 M - -
Net income 2022 -172 M - -
Net cash 2022 63,2 M - -
P/E ratio 2022 -10,6x
Yield 2022 -
Capitalization 1 865 M 1 865 M -
EV / Sales 2022 33,3x
EV / Sales 2023 8,13x
Nbr of Employees 198
Free-Float 80,1%
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Mean consensus BUY
Number of Analysts 14
Last Close Price 46,27 $
Average target price 85,91 $
Spread / Average Target 85,7%
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Managers and Directors
Herriott Tabuteau Chairman & Chief Executive Officer
Nick Pizzie Chief Financial & Accounting Officer
Joseph Debrah-Afful Controller
Amanda Jones Senior Vice President-Clinical Development
Mark L. Jacobson Secretary & Senior Director-Operations
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