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axsome.com

Stage

IPO | IPO

Total Raised

$9.7M

Date of IPO

11/19/2015

Market Cap

1.09B

Stock Price

27.62

About Axsome Therapeutics

Axsome Therapeutics is a clinical stage biopharmaceutical company developing novel therapies for the management of pain and other central nervous system, or CNS, disorders. By focusing on this therapeutic area, the company is addressing significant and growing markets where current treatment options are limited or inadequate. Its product candidate portfolio includes two late-stage candidates, AXS-02 and AXS-05, which we are developing for multiple indications.

Axsome Therapeutics Headquarter Location

45 Rockefeller Plaza Suite 2000

New York, New York, 10111,

United States

212-203-5072

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Expert Collections containing Axsome Therapeutics

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Axsome Therapeutics is included in 1 Expert Collection, including Biopharma Tech.

B

Biopharma Tech

15,535 items

Companies involved in the research, development, and commercialization of chemically- or biologically-derived therapeutic & theranostic drugs. Excludes vitamins/supplements, CROs/clinical trial services.

Axsome Therapeutics Patents

Axsome Therapeutics has filed 113 patents.

The 3 most popular patent topics include:

  • Analgesics
  • Hepatotoxins
  • Fluoroarenes
patents chart

Application Date

Grant Date

Title

Related Topics

Status

7/1/2021

4/5/2022

Dosage forms, Pharmaceutical industry, Piperidines, Pharmacokinetics, Amines

Grant

Application Date

7/1/2021

Grant Date

4/5/2022

Title

Related Topics

Dosage forms, Pharmaceutical industry, Piperidines, Pharmacokinetics, Amines

Status

Grant

Latest Axsome Therapeutics News

Pomerantz Law Firm Announces the Filing of a Class Action Against Axsome Therapeutics, Inc. and Certain Officers – AXSM

May 14, 2022

Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system disorders in the United States. The Company is developing, among other product candidates, AXS-07, a novel, oral, rapidly absorbed, multi-mechanistic, and investigational medicine for the acute treatment of migraine. Axsome consistently touted AXS-07’s regulatory and commercial prospects in anticipation of the Company’s submission a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for AXS-07 for the acute treatment of migraine (the “AXS-07 NDA”) based on the drug’s positive results in two Phase 3 trials. However, unbeknownst to investors, the Company’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (“CMC”) issues. The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Axsome’s CMC practices were deficient with respect to AXS-07 and its manufacturing process; (ii) as a result, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline; (iii) the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA; (iv) accordingly, the FDA was unlikely to approve the AXS-07 NDA; (v) as a result of all the foregoing, Axsome had overstated AXS-07’s regulatory and commercial prospects; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times. On November 5, 2020, Axsome issued a press release reporting the Company’s third quarter 2020 results. That press release disclosed that the Company “plans to submit the [AXS-07] NDA to the FDA in the first quarter of 2021, versus previous guidance of the fourth quarter of 2020, to allow for inclusion of supplemental manufacturing information to ensure a robust submission package.” On this news, Axsome’s stock price fell $5.22 per share, or 6.99%, to close at $69.51 per share on November 5, 2020. Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Exchange Commission that, “[o]n April 22, 2022, Axsome . . . was informed by the [FDA] that [CMC] issues identified during the FDA’s review of the Company’s [NDA] for its AXS-07 product candidate for the acute treatment of migraine are unresolved.”  That filing also disclosed that “[b]ased upon the time remaining in the NDA review cycle, the Company expects to receive a Complete Response Letter [(‘CRL’)] with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.” On this news, Axsome’s stock price fell $8.60 per share, or 21.99%, to close at $30.50 per share on April 25, 2022. Finally, on May 2, 2022, Axsome announced that it received a CRL from the FDA regarding the AXS-07 NDA for the acute treatment of migraine. According to the Company, “[t]he principal reasons given in the CRL relate to [CMC] considerations” including “the need for additional CMC data pertaining to the drug product and manufacturing process.” Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com . CONTACT:

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