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AXSOME THERAPEUTICS, INC.

(AXSM)
  Report
Delayed Nasdaq  -  04:00 2022-10-03 pm EDT
45.33 USD   +1.59%
10/03Sector Update: Health Care Stocks Edge Higher Premarket Monday
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10/03Axsome Therapeutics, Inc. : Other Events, Financial Statements and Exhibits (form 8-K)
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10/03Axsome Therapeutics Says Narcolepsy Drug Met Primary Endpoint in Study
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Axsome surges after oral depression drug gets FDA approval

08/19/2022 | 08:03am EDT
Signage is seen outside of FDA headquarters in White Oak, Maryland

(Reuters) - The U.S. Food and Drug Administration has approved Axsome Therapeutics Inc's oral depression pill, the company said on Friday, sending its shares soaring 38% in premarket trading.

The approval clears the way for the drugmaker to make its treatment available for more than 20 million Americans in a highly competitive market. Axsome said the treatment, Auvelity, will be commercially available in the fourth quarter.

The drug is designed to reduce symptoms of depression as early as one week and will compete with existing antidepressants, which take longer to show any effect.

Truist Securities analyst Joon Lee said the approval "represents a turning point for the company" and the drug could be a commercial success given its rapid mechanism of action.

New depression treatments have been rare, and the field of anti-depressants has been littered with trial failures. Johnson & Johnson's nasal spray Spravato was approved in 2019, making it the first new type of antidepressant in more than 30 years.

The long-awaited approval for Axsome's pill comes after the agency found deficiencies in the company's marketing application last year.

Axsome had since then been working with the FDA to resolve the agency's concerns.

Auvelity, which targets several neurotransmitters including serotonin, had succeeded in reducing symptoms of major depressive disorder (MDD) in a late-stage trial in 2019.

(Reporting by Amruta Khandekar; Editing by Anil D'Silva)


© Reuters 2022
All news about AXSOME THERAPEUTICS, INC.
10/03Sector Update: Health Care Stocks Edge Higher Premarket Monday
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Financials (USD)
Sales 2022 49,7 M - -
Net income 2022 -175 M - -
Net cash 2022 145 M - -
P/E ratio 2022 -10,4x
Yield 2022 -
Capitalization 1 944 M 1 944 M -
EV / Sales 2022 36,2x
EV / Sales 2023 8,87x
Nbr of Employees 198
Free-Float 80,1%
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Mean consensus BUY
Number of Analysts 14
Last Close Price 45,33 $
Average target price 101,22 $
Spread / Average Target 123%
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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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