Axsome Therapeutics, Inc. Class Action Lawsuit - AXSM

Company Name
Axsome Therapeutics, Inc.
Stock Symbol
Class Period
December 30, 2019 to April 22, 2022
Motion Deadline
July 12, 2022
Southern District of New York
15 days left to seek lead plaintiff status

Case Summary

The Axsome class action lawsuit seeks to represent purchasers of Axsome Therapeutics, Inc. (NASDAQ: AXSM) securities between December 30, 2019 and April 22, 2022, inclusive (the “Class Period”).  Commenced on May 13, 2022, the Axsome class action lawsuit – captioned Gru v. Axsome Therapeutics, Inc., No. 22-cv-03925 (S.D.N.Y.) – charges Axsome and certain of its top executive officers with violations of the Securities Exchange Act of 1934.

If you suffered significant losses and wish to serve as lead plaintiff of the Axsome class action lawsuit, please provide your information by clicking here.  You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com.  Lead plaintiff motions for the Axsome class action lawsuit must be filed with the court no later than July 12, 2022.

CASE ALLEGATIONS: Axsome 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 Axsome’s submission of 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, as the Axsome class action lawsuit alleges, Axsome’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (“CMC”) issues.

Specifically, the Axsome class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and 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) thus, Axsome had overstated AXS-07’s regulatory and commercial prospects; and (vi) consequently, Axsome’s public statements were materially false and misleading at all relevant times.

On November 5, 2020, Axsome disclosed that it “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 nearly 7%.

Then, on April 25, 2022, Axsome disclosed that, “[o]n April 22, 2022, Axsome . . . was informed by the [FDA] that [CMC] issues identified during the FDA’s review of [Axsome]’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, [Axsome] 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 an additional 22%.

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 Axsome, “[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.”

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Axsome securities during the Class Period to seek appointment as lead plaintiff in the Axsome class action lawsuit.  A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.  A lead plaintiff acts on behalf of all other class members in directing the Axsome class action lawsuit.  The lead plaintiff can select a law firm of its choice to litigate the Axsome class action lawsuit.  An investor’s ability to share in any potential future recovery of the Axsome class action lawsuit is not dependent upon serving as lead plaintiff.

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: Robbins Geller Rudman & Dowd LLP is one of the world’s leading complex class action firms representing plaintiffs in securities fraud cases.  The Firm is ranked #1 on the 2021 ISS Securities Class Action Services Top 50 Report for recovering nearly $2 billion for investors last year alone – more than triple the amount recovered by any other plaintiffs’ firm.  With 200 lawyers in 9 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig.

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