In Re Axsome Therapeutics, Inc. Stockholder Derivative Litigation

CourtCourt of Chancery of Delaware
DecidedJuly 9, 2026
Docket2025-1076-LWW
StatusPublished

This text of In Re Axsome Therapeutics, Inc. Stockholder Derivative Litigation (In Re Axsome Therapeutics, Inc. Stockholder Derivative Litigation) is published on Counsel Stack Legal Research, covering Court of Chancery of Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Axsome Therapeutics, Inc. Stockholder Derivative Litigation, (Del. Ct. App. 2026).

Opinion

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE

IN RE AXSOME THERAPEUTICS, INC. CONSOLIDATED STOCKHOLDER DERIVATIVE C.A. No. 2025-1076-LWW LITIGATION

OPINION

Date Submitted: June 22, 2026 Date Decided: July 9, 2026

Seth D. Rigrodsky, Gina M. Serra & Herbert Mondros, RIGRODSKY LAW, P.A., Wilmington, Delaware; Justin A. Kuehn & Molly J. Brown, KUEHN LAW, PLLC, Southampton, New York, Attorneys for Plaintiffs John A. Wickstrom and John Gildea Jody C. Barillare, Brian Loughnane & Amy. M. Dudash, MORGAN, LEWIS & BOCKIUS LLP, Wilmington, Delaware; Michael Blanchard, MORGAN, LEWIS & BOCKIUS LLP, Boston, Massachusetts; Christopher M. Wasil, MORGAN, LEWIS & BOCKIUS LLP, Hartford, Connecticut; Attorneys for Defendants Herriot Tabuteau, Nick Pizzie, Mark Jacobson, Cedric O’Gorman, Kevin Laliberte, Mark Coleman, Roger Jeffs, and Mark Saad, and Nominal Defendant Axsome Therapeutics, Inc.

WILL, Vice Chancellor A statute of limitations provides a crucial endpoint to litigation exposure. In

equity, this court applies the statute by analogy through the doctrine of laches.

Equity aids the vigilant.

The plaintiffs in this derivative action slept on their rights. They acknowledge

that they were on inquiry notice of their claims by April 2022, when Axsome

Therapeutics, Inc. disclosed regulatory setbacks for its leading drug candidate.

While parallel securities and derivative litigation proceeded in federal court, the

plaintiffs here did nothing.

Only as the end of the three-year limitations period loomed did the plaintiffs

send demands to inspect the company’s records. They now argue that the mere

transmission of these demands paused the clock. Their position fails on the law and

the facts.

A diligently pursued books and records suit may, in appropriate

circumstances, justify equitable tolling. But an eleventh-hour, out-of-court demand

pursued with little zeal does not. Because the plaintiffs failed to timely assert their

claims, prejudice to the defendants is presumed. No extraordinary circumstances

rebut that presumption.

The complaint is dismissed.

2 I. FACTUAL BACKGROUND

The following facts are drawn from the Verified Stockholder Derivative

Complaint (the “Complaint”) and the documents it incorporates by reference.1

A. Axsome and AXS-07

Nominal defendant Axsome Therapeutics, Inc. is a biopharmaceutical

company focused on developing innovative therapies for central nervous system

disorders.2 One of Axsome’s product candidates is AXS-07, an investigational

treatment for migraines.3

In December 2019, Axsome issued a press release announcing positive results

from AXS-07’s Phase 3 trial and estimating that it would file a New Drug

Application (NDA) with the U.S. Food and Drug Administration (FDA) in the

second half of 2020.4 The company issued similar statements over the next seven

months—in press releases, conference calls, and Securities and Exchange

1 Verified S’holder Deriv. Compl. (Dkt. 1) (“Compl.”); see also In re Lukens Inc. S’holders Litig., 757 A.2d 720, 727 (Del. Ch. 1999) (explaining that, in deciding a motion to dismiss, “the court may consider, for certain purposes, the content of documents that are integral to or are incorporated by reference into the complaint,” such as “the actual disclosures made” in the corporation’s public filings), aff’d sub nom. Walker v. Lukens, Inc., 757 A.2d 1278 (Del. 2000). Exhibits to the defendants’ opening and reply briefs are cited as “Defs.’ Ex. __.” Dkts. 12, 19. Exhibits to the plaintiffs’ opposition brief are cited as “Pls.’ Ex. __.” Dkt. 16. 2 Compl. ¶ 2. 3 Id. 4 Id. ¶ 138.

3 Commission (SEC) filings—some of which specified an NDA filing date in the

fourth quarter of 2020.5 Certain disclosures also addressed matters related to

AXS-07’s chemistry, manufacturing, and control (CMC).6 According to the

Complaint, these public statements were materially false or misleading because they

omitted purported CMC deficiencies that made Axsome’s estimated NDA filing date

“unlikely” and exaggerated AXS-07’s regulatory and commercial prospects.7

In November 2020, Axsome delayed its estimated NDA filing date to the first

quarter of 2021—a change disclosed in a press release and investor conference call.8

In March 2021, Axsome announced a further delay to the second quarter of 2021,

which it reiterated in May 2021.9 The plaintiffs allege that these statements also

omitted purported CMC issues negatively affecting the AXS-07 NDA.10

Axsome ultimately submitted the NDA in June 2021.11 In August 2021,

Axsome issued a press release announcing that it had filed the AXS-07 NDA in the

second quarter of 2021.12 It acknowledged that the FDA had identified deficiencies

5 Id. ¶¶ 140-50. 6 Id. ¶¶ 142, 146-47. 7 Id. ¶ 151. 8 Id. ¶¶ 153-60. 9 Id. ¶¶ 161-67. 10 Id. ¶ 154. 11 Id. ¶ 81. 12 Id. ¶ 168.

4 in a separate NDA for a different product, AXS-05.13 The next month, Axsome

announced that the FDA had accepted the AXS-07 NDA and set a “[Prescription

Drug User Fee Act (PDUFA)] target action date of April 30, 2022.”14 Six months

later, in March 2022, Axsome announced that the FDA expected to complete its

facility inspection before the PDUFA date.15 According to the plaintiffs, these

statements were false or misleading because they overstated AXS-07’s regulatory

and commercial prospects and omitted purported CMC deficiencies that made FDA

approval of the NDA “unlikely.”16

B. The Stock Drop

On April 25, 2022, Axsome filed a Form 8-K with the SEC disclosing that,

three days earlier, the FDA notified it of unresolved CMC issues identified during

its review of the AXS-07 NDA.17 Axsome stated that it expected to receive a letter

from the FDA by the end of the month declining to approve the NDA in its current

form.18

13 Id. ¶¶ 168-69. 14 Id. ¶ 173. A Prescription Drug User Fee Act (PDUFA) target action date is the date by which the FDA intends to issue a decision regarding an NDA. See Keith Speights, What Is a PDUFA Date?, The Motley Fool (July 3, 2025), https://www.fool.com/terms/p/pdufa- date/. 15 Compl. ¶ 180. 16 Id. ¶ 183. 17 Id. ¶ 185. 18 Id.

5 On this news, Axsome’s stock price fell by $8.60 per share.19

C. The Federal Actions

In May 2022, an Axsome stockholder filed a putative class action complaint

in the United States District Court for the Southern District of New York (the

“Securities Action”) against Axsome and certain of its officers.20 The plaintiff

claimed that the defendants violated the Securities Exchange Act of 1934 by making

false and misleading statements about the status and prospects of the AXS-07 NDA

and by failing to disclose purported CMC deficiencies that made FDA approval

unlikely.21

In September 2023, the court dismissed the initial complaint.22 The plaintiff

filed an amended complaint. In March 2025, the court granted a motion to dismiss

the amended complaint as to certain officers but denied it as to Axsome, its Chief

19 Id. ¶ 186. 20 See Compl., In re Axsome Therapeutics, Inc. Sec. Litig., No. 1:22-cv-03925 (S.D.N.Y. May 13, 2022); cf. In re Career Educ. Corp. Deriv. Litig., 2007 WL 2875203, at *9 (Del. Ch. Sept. 28, 2007) (“[T]he court also may take judicial notice of publicly filed documents, such as documents publicly filed in litigation pending in other jurisdictions.” (citation omitted)). 21 See Compl.

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