Wentz v. Moderna, Inc. et al

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
MASON WENTZ, Individually and on
Behalf of All Others Similarly Situated,
Plaintiff,
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* Civil Action No. 1:24-cv-12058-IT
v. 	*
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MODERNA, INC., et al.,
Defendants.
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MEMORANDUM & ORDER
October 8, 2026
TALWANI, D.J.
Lead Plaintiff Pak Sa Kim brings this putative securities class action suit against
Defendants Moderna, Inc., and its executives Stephane Bancel, James Mock, and Stephen Hoge
(collectively “Moderna”), alleging that they violated the Securities Exchange Act by
misrepresenting the efficacy rate of a vaccine product. Am. Compl. ¶¶ 3–14 [Doc. No. 62]. Lead
Plaintiff has alleged that, despite the Food and Drug Administration’s (“FDA”) approval of the
product based on a 78.7% efficacy rate, Moderna intentionally misstated that its vaccine was
83.7% effective, thereby artificially inflating stock prices. Id. at ¶¶ 3–14, 130.
Moderna filed a Motion to Dismiss [Doc. No. 71] and over forty exhibits in support
thereof. See Rosenfeld Decl. [Doc. No. 72]. Lead Plaintiff opposed Moderna’s motion and
moved to strike certain of Moderna’s supporting exhibits. Opp’n [Doc. No. 75]; Pl.’s Mot. to
Strike [Doc. No. 76]. This court referred Lead Plaintiff’s Motion to Strike [Doc. No. 76] to the
Magistrate Judge for decision and Moderna’s Motion to Dismiss [Doc. No. 71] for a Report and
Recommendation. Elec. Order [Doc. No. 87].
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The Magistrate Judge allowed Lead Plaintiff’s Motion to Strike [Doc. No. 76], finding
that the challenged exhibits were not incorporated by reference into the Amended Complaint
[Doc. No. 62]. Order on Mot. to Strike 5–7 [Doc. No. 93]. As to Moderna’s Motion to Dismiss
[Doc. No. 71], the Magistrate Judge recommended finding that Lead Plaintiff had “plausibly
allege[d] that it was inaccurate [for Moderna] to continue to publicize the 83.7% figure, while
omitting to mention that updated data pointed to a lower figure.” R.&R. 26 [Doc. No. 94].
However, the Magistrate Judge also recommended dismissal of the Amended Complaint [Doc.
No. 62] despite the alleged misleading omission, on the ground that Lead Plaintiff had failed to
adequately plead scienter. R.&R. 48–49 [Doc. No. 94] (“Because the factual allegations of the
Complaint lend more support to an innocent explanation than one of scienter, Plaintiff has failed
under the PSLRA to allege a viable Section 10(b)/Rule 10b-5 claim.”).
The parties filed objections and replies. Def.’s Obj. to Order [Doc. No. 96]; Def.’s Obj. to
R.&R. [Doc. No. 98]; Pl.’s Obj. to R.&R. [Doc. No. 99]; Pl.’s Reply [Doc. No. 101]; Def.’s
Reply [Doc. No. 102].
For the reasons discussed below, on de novo review, the court overrules Lead Plaintiff’s
objections, ADOPTS the Magistrate Judge’s Report & Recommendation [Doc. No. 94] as to the
failure to adequately plead scienter, and DISMISSES the Amended Complaint [Doc. No. 62].
I. 	Background
The court adopts, and incorporates by reference, the background set forth in the Report &
Recommendation [Doc. No. 94]. See id. at 3–10.
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II. 	Standard of Review
A. Report and Recommendation
Following the issuance of a Report and Recommendation, the court reviews de novo the
matters delimited by timely1 and appropriately specific objections. 28 U.S.C. § 636(b); Fed. R.
Civ. P. 72(b)(3); see United States v. J.C.D., 861 F.3d 1, 5 n.1 (1st Cir. 2017). The court
thereafter “may accept, reject, or modify, in whole or in part, the findings or recommendations
made by the magistrate judge.” 28 U.S.C. § 636(b)(1)(C).
B. Motion to Dismiss
When evaluating a motion to dismiss for failure to state a claim, the court assumes “the
truth of all well-pleaded facts” and draws “all reasonable inferences in the plaintiff's favor.”
Nisselson v. Lernout, 469 F.3d 143, 150 (1st Cir. 2006). To survive dismissal, a complaint must
contain sufficient factual material to “state a claim to relief that is plausible on its face.” Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 570 (2007). “While a complaint attacked by a Rule 12(b)(6)
motion to dismiss does not need detailed factual allegations . . . [f]actual allegations must be
enough to raise a right to relief above the speculative level . . . .” Id. at 555 (citations omitted).
“A claim has facial plausibility when the plaintiff pleads factual content that allows the court to
draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft
v. Iqbal, 556 U.S. 662, 678 (2009).
“Exhibits attached to the complaint are properly considered part of the pleading for all
purposes, including Rule 12(b)(6).” Trans-Spec Truck Serv., Inc. v. Caterpillar Inc., 524 F.3d
315, 321 (1st Cir. 2008) (quotations omitted). In ruling on a motion to dismiss, “a judge can mull
1 An objection is timely if filed within 14 days of receipt of the Magistrate Judge’s Report and
Recommendation. 28 U.S.C. § 636(b); Fed. R. Civ. P. 72(b).
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over ‘documents incorporated by reference in [the complaint], matters of public record, and other
matters susceptible to judicial notice.’” Lydon v. Local 103, Int’l Bhd. of Elec. Workers, 770
F.3d 48, 53 (1st Cir. 2014) (alteration in original) (quoting Giragosian v. Ryan, 547 F.3d 59, 65
(1st Cir. 2008)). A court may consider extrinsic documents “without converting the motion into
one for summary judgment” where “the relevant entirety of a document [is] integral to or
explicitly relied upon in the complaint” and thus incorporated by reference. Clorox Co. P.R. v.
Proctor & Gamble Comm. Co., 228 F.3d 24, 32 (1st Cir. 2000) (quotation omitted).
C. Securities Fraud
Securities fraud allegations are held to heightened pleading requirements under Federal
Rule of Civil Procedure 9(b) and the Private Securities Litigation Reform Act of 1995
(“PSLRA”). 15 U.S.C. § 78u–4(b)(2); N. Am. Cath. Educ. Programming Found., Inc. v.
Cardinale, 567 F.3d 8, 15 (1st Cir. 2009); see In re Boston Sci. Corp. Sec. Litig., 686 F.3d 21,
27, 30 (1st Cir. 2012). As with all allegations of fraud, a complaint must be dismissed unless it
“state[s] with particularity facts giving rise to a strong inference that the defendant acted with the
required state of mind.” 15 U.S.C. § 78u–4(b)(2); see Thant v. Karyopharm Therapeutics Inc., 43
F.4th 214, 222 (1st Cir. 2022).
Liability under Section 10(b) and Rule 10b-5 requires scienter. See 15 U.S.C. § 78u-
4(b)(2). Scienter is “a mental state embracing intent to deceive, manipulate, or defraud.” Matrixx
Initiatives, Inc. v. Siracusano, 563 U.S. 27, 48 (2011) (quoting Ernst & Ernst v. Hochfelder, 425
U.S. 185, 193 n.12 (1976)). It requires “a showing of either conscious intent to defraud or ‘a high
degree of recklessness.’” ACA Fin. Guar. Corp. v. Advest, Inc., 512 F.3d 46, 58 (1st Cir. 2008)
(quoting Aldridge v. A.T. Cross Corp., 284 F.3d 72, 82 (1st Cir. 2002)). A high degree of
recklessness “demands ‘a highly unreasonable omission,’ one that not only involves ‘an extreme
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departure from the standards of ordinary care,’ but also ‘presents a danger of misleading buyers
or sellers that is either known to the defendant or is so obvious the actor must have been aware of
it.’” Corban v. Sarepta Therapeutics, Inc., 868 F.3d 31, 37 (1st Cir. 2017) (quoting In re Smith &
Wesson Holding Corp. Sec. Litig., 669 F.3d 68, 77 (1st Cir. 2012)).
Under the PSLRA, a plaintiff must “state with particularity facts giving rise to a strong
inference” of scienter. 15 U.S.C. § 78u-4(b)(2). To qualify as “strong,” the Supreme Court has
instructed that “an inference of scienter must be more than merely plausible or reasonable—it
must be cogent and at least as compelling as any opposing inference of nonfraudulent intent.”
Tellabs, Inc. v. Makor Issues & Rts., Ltd., 551 U.S. 308, 314 (2007). When there are equally
strong inferences for and against scienter, “the draw is awarded to the plaintiff.” City of
Dearborn Heights Act 345 Police & Fire Ret. Sys. v. Waters Corp., 632 F.3d 751, 757 (1st Cir.
2011). “[W]here a complaint is devoid of any direct-evidence allegations, the indirect-evidence
allegations in the complaint will need to do more work to carry the burden of raising a ‘strong
inference of scienter’ on their own.” Brennan v. Zafgen, Inc., 853 F.3d 606, 615 n.8 (1st Cir.
2017). Cognizant that “[e]ach individual fact about scienter may provide only a brushstroke,”
courts must assess each asserted fact individually before considering “the resulting portrait” and
weighing them cumulatively. Loc. No. 8 IBEW Ret. Plan & Tr. v. Vertex Pharms., Inc., 838 F.3d
76, 81 (1st Cir. 2016) (quoting In re Cabletron Sys., Inc., 311 F.3d 11, 40 (1st Cir. 2002)). “[A]
plaintiff ‘may combine various facts and circumstances indicating fraudulent intent,’ including
those demonstrating ‘motive and opportunity,’ to satisfy the scienter requirement.” Brennan, 853
F.3d at 614 (citation modified) (quoting Aldridge, 284 F.3d at 82). “However, ‘catch-all
allegations’ which merely assert motive and opportunity, without something more, fail to satisfy
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the PSLRA.” In re Cabletron Sys., Inc., 311 F.3d at 39 (quoting In re Advanta Corp. Secs. Litig.,
180 F.3d 525, 535 (3rd Cir. 1999)).
III. 	Discussion
Lead Plaintiff has failed to clear the high bar for pleading scienter. The Magistrate Judge
reported that the Amended Complaint
includes no well-pleaded factual allegations to suggest that [Moderna] actually
believed during the Class Period that the lower efficacy figure was the correct one,
or even that it was the figure that the FDA would ultimately adopt. Still less is there
any compelling inference that [Moderna] had any motive to lie about it.
R.&R. 29 [Doc. No. 94]. This court agrees. Lead Plaintiff has alleged no facts from which the
court may infer that Moderna knew or recklessly disregarded that the 83.7% efficacy figure was
materially false during the class period. See In re Cabletron, 311 F.3d at 40.
As the Magistrate Judge correctly noted, “the only thing to support an inference that
[Moderna] knew the original figure was inaccurate is the bare fact that they had assembled data
that yielded a different, lower figure[.]” R.&R. 30 [Doc. No. 94] (emphasis in original). But it
would be unreasonable to infer from this fact that Moderna “understood that only the lower
efficacy figure was accurate, or even that [Moderna] anticipated the FDA would adopt the lower
figure.” Id. (emphasis in original).
The court considers Lead Plaintiff’s objections to the Report & Recommendation [Doc.
No. 94] in turn.
A. FDA May 29, 2024 Memorandum
Lead Plaintiff argues that this court should interpret the FDA’s January 25, 2024 request
for updated data as “the FDA rejecting the original primary analysis dataset as complete[.]” Pls.’
Obj. to R.&R. 4 [Doc. No. 99]. Lead Plaintiff relies on the following portion of the FDA’s May
29, 2024 BLA Clinical Review Memorandum for support:
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On January 25, 2024, due to inconsistencies in the datasets submitted for [the
ConquerRSV Trial], FDA requested that the Applicant complete all data cleaning
activities up to the June 24, 2023 data cutoff and submit updated datasets for FDA
review. The updated data were used in the primary and additional efficacy analyses
and identified additional RSV cases with onset prior to data cutoff which met the
study case definition. The additional identified cases were incorporated into the
estimates of vaccine efficacy in this review memorandum.
Bigin Aff. Ex. 2, at 3 [Doc. No. 74-2] (“May 29, 2024 FDA Clinical Review Memo”).2 Lead
Plaintiff argues that, because the FDA referred to “inconsistencies in the datasets,” Moderna was
on notice as of January 25, 2024, that the FDA viewed its vaccine efficacy rate as inaccurate.
Pls.’ Obj. to R.&R. 4, 8–9 [Doc. No. 99].
However, as the Magistrate Judge explained, the FDA document identifies the January
2024 request, but not its content. R.&R. 16 [Doc. No. 94]. The document does not state that the
FDA communicated to Moderna any characterization of the data the company previously
provided, only that the FDA requested “updated datasets” from Moderna. May 29, 2024 FDA
Clinical Review Memo 3 [Doc. No. 74-2]. Accordingly, the court may not infer from the request
as described in the FDA document that Moderna knew the FDA would determine efficacy based
on the updated and expanded data Moderna provided in February 2024. See R.&R. 16 [Doc. No.
94] (“[T]here are no factual allegations in the Complaint that the FDA used the term
‘inconsistencies’ in the January 2024 communication when it requested the additional data.”);
see also In re TransMedics Grp., Inc. Sec. Litig., No. 1:25-cv-10385-LTS, __ F. Supp. 3d __,
2026 WL 2098148, at *21 (D. Mass. July 21, 2026) (in finding no scienter, court explained that
while timing of CEO’s stock sales may have raised an inference that he was aware of company’s
poor performance during the quarter, they did not suggest he specifically knew that pricing
pressure or competitive dynamics contributed to company’s declining revenue).
2 This document is quoted in the Amended Complaint [Doc. No. 62] and may therefore be
incorporated by reference into the pleading. See id. ¶ 57; Clorox Co. P.R., 228 F.3d at 32.
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B. President Hoge’s June 10, 2024 Statement
Lead Plaintiff also argues that Moderna President Steven Hoge’s June 10, 2024 statement
constitutes an admission that Moderna knew the FDA would approve mRESVIA at the 78.7%
efficacy rate. Pls.’ Obj. to R.&R. 10–11 [Doc. No. 99].3 Specifically, Lead Plaintiff asserts that
the Magistrate Judge failed to appropriately take into account Hoge’s statement that “we
ultimately agreed with the [FDA] to include” the additional cases as updated data. Id. at 11;
Company Conference Presentation Tr. ECF 3 [Doc. No. 72-16]. Lead Plaintiff argues that
“Moderna’s agreement with the FDA shows that Moderna knew the FDA would not approve the
83.7% [vaccine efficacy] rate that [Moderna] continued to tout during the Class Period.” Pls.’
Obj. to R.&R. 12 [Doc. No. 99].
3 On June 10, 2024, Hoge presented at a company conference and discussed the FDA’s recent
approval of mRESVIA. Am. Compl. ¶ 60 [Doc. No. 62]; Rosenfeld Decl. Ex. 16, at ECF 3 [Doc.
No. 72-16] (“Company Conference Presentation Tr.”). In explaining the FDA’s approval based
on the 78.7% efficacy rate, Hoge stated:
The label data from the FDA approval process was 78.7% efficacy. The prior—the
primary analysis, as per protocol, primary analysis had been 83.7%, substantially
the same numbers with the same overlap. So what’s the different [sic]? During the
process of the review with the FDA, they asked us to include a set of cases, about
20 cases that were not confirmed at the time of the primary analysis. So these are
people that might have developed a symptom, but at the time of the data cutoff by
the DSMB [Data and Safety Monitoring Boards], they had not had a PCR
[polymerase chain reaction] confirmation that it was RSV. It could have been
COVID, it could have been flu, lots of other things were diagnosed during that time.
When you’re running a clinical trial and you’re following the protocol, when you
hit that data cutoff, we’re blinded. We provide the data the DSMB, and that blinded
data was 83.7%. But the FDA and regulators have the privilege of being able to
look retrospectively and decide if they want to include those numbers. And because
it added about 20 more cases to that primary analysis, we ultimately agreed with
the agency to include those because they broke 15 and 5, they slightly lowered the
number by a couple of percent. But otherwise, it’s substantially the same result.
Company Conference Presentation Tr. ECF 3 [Doc. No. 72-16].
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As the Magistrate Judge explained, Hoge’s statement that Moderna agreed to include the
additional data is not equivalent to a statement that “Moderna agreed it was appropriate to
include the additional (unblinded) cases, or that it was more accurate to include them, or that the
FDA was correct in opting to include them.” R.&R. 38 [Doc. No. 94]. Hoge’s statement only
reflects Moderna’s agreement with the FDA’s process, rather than any admission that the 83.7%
efficacy rate was inaccurate. See In re Boston Scientific Corp. Sec. Litig., 686 F.3d at 31 (“In
cases where we have found the pleading standard satisfied, the complaint often contains clear
allegations of admissions, internal records or witnessed discussions suggesting that at the time
they made the statements claimed to be misleading, the defendant officers were aware that they
were withholding vital information or at least were warned by others that this was so.”); cf.
Aldridge, 284 F.3d at 76, 83 (finding strong inference of scienter where plaintiff pleaded facts
including company executive’s statement in newspaper and additional evidence that executive
knew the statement to be false or misleadingly incomplete at the time of publication).
C. Motive
Lead Plaintiff argues that, in reporting no evidence in support of scienter, the Magistrate
Judge failed to appropriately consider the Amended Complaint’s [Doc. No. 62] allegations
regarding Moderna’s motive to misrepresent mRESVIA’s efficacy. Pls.’ Obj. to R.&R. 15–16
[Doc. No. 99]. Lead Plaintiff alleged that the approval of mRESVIA was of particular import to
Moderna because the profitability of its first and primary product, a vaccine for COVID-19, had
decreased following the abatement of the pandemic. Am. Compl. ¶¶ 3, 114 [Doc. No. 62].
Additionally, Lead Plaintiff alleged that Moderna was specifically motivated to publicize a
higher efficacy rate for mRESVIA because in May 2023, the FDA had approved a first market
entrant RSV vaccine at an efficacy rate lower than 83.7% but higher than 78.7%. Id. ¶¶ 51, 113,
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117. Lead Plaintiff points to allegations in the Amended Complaint [Doc. No. 62] regarding
financial analysts’ perspectives on the relationship between market entry and market share as
support for its contention that Moderna was motivated to misrepresent mRESVIA’s efficacy to
compensate for its later entry into the market. Id. ¶¶ 39–41.
As the Magistrate Judge explained, Lead Plaintiff’s motive allegations are insufficient to
permit the court to reasonably infer that Moderna stood to gain so much by a 5% delta in vaccine
efficacy such that the company intentionally withheld the figure from investors for three months,
knowing that the FDA would ultimately approve the drug based on a lower figure. R.&R. 46–48
[Doc. No. 94]. While Plaintiff has reasonably alleged that Moderna wanted to use the higher
number to generally improve revenue and compete with other RSV vaccines, no particularized
facts support a reasonable inference that Moderna “was cash-strapped or desperate for new
investment” in such a way that a temporary three-month boost in share value was necessary. Id.
at 45; cf. In re Cabletron Sys., Inc., 311 F.3d at 39 (finding scienter where complaint alleged
with particularity the “concealment of the serious and worsening deterioration of Cabletron’s
financial health as a significant motive for the alleged fraud”).
D. Core Operations
Finally,4 Lead Plaintiff argues that the court should infer that Moderna knew the FDA
would approve mRESVIA based on the lower efficacy rate because the approval was part of
Moderna’s core business operations. Pls.’ Obj. to R.&R. 12–13 [Doc. No. 99]. As explained by
4 Lead Plaintiff also objects to the Magistrate Judge’s report that the materiality of the vaccine
efficacy rate delta undercuts any inferences of scienter, see Pls.’ Obj. to R.&R. 13–15 [Doc. No.
99], and that the competing inferences of Moderna’s nonactionable conduct are stronger than
inferences of scienter, id. at 16–17. But where the court finds no evidence in support of scienter,
the court need not consider whether Lead Plaintiff’s insufficient showing is further debilitated by
undercutting and/or competing inferences.
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the Magistrate Judge, a “core operations” theory can be used to plead scienter when bolstered by
“other significant evidence of a defendant’s intent or recklessness, or a plus factor.” R.&R. 42
[Doc. No. 94] (quoting Leung v. bluebird bio, Inc., 599 F. Supp. 3d 49, 66 (D. Mass. 2022)). The
court agrees with the Magistrate Judge that Lead Plaintiff has failed to plead sufficient facts
regarding Moderna’s “intent or recklessness, or [another] plus factor.” Id.; see Metzler Asset
Mgmt. GmbH v. Kingsley, 928 F.3d 151, 165 (1st Cir. 2019) (“[C]orporate management’s
general awareness of the day-to-day workings of the company’s business does not establish
scienter—at least absent some additional allegation of specific information conveyed to
management and related to the fraud or other allegations supporting scienter.”) (quotation
omitted).
Lead Plaintiff urges the court to consider Hoge’s June 10, 2024 statement as evidence
sufficient to raise the core operations theory. See Pls.’ Obj. to R.&R. 12–13 [Doc. No. 99]. But,
as explained above, the court is unable to reasonably construe Hoge’s statement as an admission.
See supra Part III.C.2. Viewed holistically, Lead Plaintiffs’ allegations are distinct from other
cases in which courts permitted plaintiffs to rely on the core operations theory to plead scienter.
For example, in Olsen v. Agenus Inc., the court found it “reasonable to infer that executives
would have knowledge of the associated clinical trials and development activities” where the
“company focused exclusively on [the] product” that was the subject of that research and
activity. No. 24-cv-12299-AK, 2026 WL 810814, at *11 (D. Mass. Mar. 24, 2026), appeal
pending, No. 26-1421 (1st Cir. Apr. 23, 2026). The Olsen court nevertheless found no strong
inference of scienter for corporate defendants alleged merely to have had “corporate
responsibilities as high-ranking executives.” Id. at *13. However, the court found that the
applicable core operations theory in conjunction with (1) the company’s co-founder’s public
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misleading omission; and (2) evidence of his knowledge that the statement was misleading, to be
cumulatively sufficient to draw a strong inference of scienter for the co-founder. Id. The
Amended Complaint [Doc. No. 62] lacks any particularized allegations that Hoge, or any other
Moderna employee, “intended to or recklessly disregarded the risk of deceiving investors[,]”
such that the core operations theory would be applicable here. Olsen, 2026 WL 810814, at *13.
IV. 	Conclusion
For the foregoing reasons, the court overrules Lead Plaintiff’s Objections [Doc. No. 99],
adopts the Report & Recommendation [Doc. No. 94] insofar as it finds that Lead Plaintiff has
failed to plead facts sufficient to raise a strong inference of scienter, and DISMISSES the
Amended Complaint [Doc. No. 62].5
IT IS SO ORDERED.
October 8, 2026 	/s/ Indira Talwani
United States District Judge
5 The court notes Moderna’s Objections [Doc. No. 96] to the Magistrate Judge’s Order [Doc. No.
93] granting Lead Plaintiff’s Motion to Strike [Doc. No. 76] and Moderna’s Partial Objection
[Doc. No. 98] to portions of the Report & Recommendation [Doc. No. 94]. These objections are
moot where the court has adopted the Magistrate Judge’s Report & Recommendation [Doc. No.
94] as to Lead Plaintiff’s failure to plead scienter.
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