Leung v. Bluebird Bio, Inc.

UNITED STATES DISTRICT COURT

DISTRICT OF MASSACHUSETTS

__________________________________________

)

)

PETER LEUNG, individually and on )

behalf of all others similarly situated, )

)

Plaintiff, )

)

v. ) Case No. 21-cv-10335-DJC

)

BLUEBIRD BIO, INC., NICK LESCHLY, )

and CHIP BAIRD, )

)

Defendants. )

)

__________________________________________)

MEMORANDUM AND ORDER

CASPER, J. April 21, 2022

I. Introduction

Lead plaintiff Jerry Hannah (“Plaintiff”)1 has filed this class action lawsuit against bluebird

bio, Inc. (“bluebird” or the “Company”), Nick Leschly (“Leschly”) and Chip Baird (“Baird”),

bluebird’s chief executive officer and chief financial officer, respectively, (collectively,

“Defendants”) alleging securities fraud in violation of Sections 10(b) and 20(a) of the Securities

Exchange Act of 1934 (“Exchange Act”) and Securities and Exchange Commission Rule 10b-5

(“Rule 10b-5”) between May 11, 2020 and November 4, 2020 (the “Class Period”). D. 26.

Defendants have moved to dismiss the amended complaint. D. 30. For the reasons stated below,

the Court ALLOWS the motion.

1 This action was originally filed by Peter Leung, individually and on behalf of all others

similarly situated. D. 1. The Court, upon motion, subsequently appointed Jerry Hannah as lead

plaintiff. D. 22.

II. Standard of Review

For allegations of securities fraud under Sections 10(b) and 20(a) of the Exchange Act, a

plaintiff “must plead the circumstances of the fraud with particularity, pursuant to Rule 9(b),” Hill

v. Gozani, 638 F.3d 40, 55 (1st Cir. 2011), and, pursuant to the Private Securities Litigation Reform

Act (“PSLRA”), must also “specify each statement alleged to have been misleading [and] the

reason or reasons why the statement is misleading,” id. (alteration in original) (citation and internal

quotation marks omitted).

As part of the inquiry under Tellabs v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322–23

(2007), courts engage in a particularized scrutiny of private securities complaints. See, e.g., Zucco

Partners, LLC v. Digimarc Corp., 552 F.3d 981, 996 (9th Cir. 2009). Nevertheless, the PSLRA’s

pleading standard is not an insurmountable bar. As required by Tellabs, the Court considers the

allegations collectively to determine whether they give rise to a strong inference of scienter. Id. at

991–92 (citing Tellabs, 551 U.S. at 323).

As with any Rule 12(b)(6) motion, the Court must “accept well-pleaded factual allegations

in the complaint as true and view all reasonable inferences in the plaintiffs’ favor.” ACA Fin.

Guar. Corp. v. Advest, Inc., 512 F.3d 46, 58 (1st Cir. 2008).

III. Factual Background

A. Materials Outside the Pleadings

As a preliminary matter, Plaintiff argues that the Court may not consider, or may consider

only in a limited capacity, eighteen exhibits marked A through R submitted by Defendants in

connection with their motion to dismiss. D. 34 at 17–22; see D. 32. According to Plaintiff, the

Court may consider Exhibits B, G, H, I, J, N, P and Q, which reference documents cited or quoted

in the amended complaint, only for the purpose of assessing “the existence of warning language

for purported forward-looking statements.” D. 34 at 20–21. Further, Plaintiff contends that the

Court may not consider Exhibits C through F, K through M, or O through R since they are neither

referenced in the amended complaint nor submitted for any allowable purpose. Id. at 21–22.

At the motion to dismiss stage, the Court ordinarily “may not consider any documents that

are outside of the complaint, or not expressly incorporated therein, unless the motion is converted

into one for summary judgment.” Alt. Energy, Inc. v. St. Paul Fire & Marine Ins. Co., 267 F.3d

30, 33 (1st Cir. 2001). “There is, however, a narrow exception ‘for documents the authenticity of

which are not disputed by the parties; for official public records; for documents central to

plaintiffs’ claim; or for documents sufficiently referred to in the complaint.’” Id. (quoting

Watterson v. Page, 987 F.2d 1, 3 (1st Cir. 1993)).

Exhibits B, G, H, I, J, N, P and Q—Securities and Exchange Commission (“SEC”) filings,

analyst conference call transcripts and a Food and Drug Administration (“FDA”) guidance

document—constitute documents “sufficiently referred to in the complaint” for consideration at

the motion to dismiss stage. See Alt. Energy, 267 F.3d at 33; D. 32. Plaintiff argues that, while

the Court may note these exhibits’ existence, it may not consider them for the truth of any matter

asserted therein. D. 34 at 19, 21. These exhibits, however, are “relevant not for the truth of

anything asserted in [them].” See Torrens v. Lockheed Martin Servs. Grp., Inc., 396 F.3d 468,

473 (1st Cir. 2005). Rather, they address bluebird’s representations to its investors and what, if

any, FDA guidance was available to bluebird when it made those representations. Cf. id.

(considering document “relevant . . . simply as a legally significant event, like a treaty or a will”);

Kader v. Sarepta Therapeutics, Inc., No. 1:14-CV-14318-ADB, 2016 WL 1337256, at *11

(D. Mass. Apr. 5, 2016) (considering FDA statements relevant to, among other things, “the total

mix of information available to the market during the Class Period”). Accordingly, the Court may

consider these exhibits without the restriction argued by Plaintiff.

The Court also may consider Exhibits C, D, E, F, G, K and R as official public records.

See D. 32. While not referenced in the amended complaint, these exhibits contain excerpts from

SEC filings and FDA documents proper for consideration at the motion to dismiss stage. See

Apotex Inc. v. Acorda Therapeutics, Inc., 823 F.3d 51, 59–60 (2d Cir. 2016) (considering FDA

guidance at motion to dismiss stage because it “is publicly available and its accuracy cannot

reasonably be questioned”); Leavitt v. Alnylam Pharms., Inc., 525 F. Supp. 3d 259, 266 n.1

(D. Mass. 2021) (stating that the court “may, in its discretion, take judicial notice of FDA

documents”); In re Vertex Pharms. Inc., Sec. Litig., 357 F. Supp. 2d 343, 352 n.4 (D. Mass. 2005)

(taking judicial notice of FDA policy “as a matter of public record”); In re Stone & Webster, Inc.,

Sec. Litig., 253 F. Supp. 2d 102, 128 n.11 (D. Mass. 2003) (explaining that a district court may

“consider documents required to be filed, and actually filed, with the SEC on a motion to dismiss”).

By contrast, Exhibits L, M and O do not fall within any of the exceptions for consideration

at this stage. Exhibit L purports to be an academic journal article. D. 32-12. Exhibits M and O

purport to be conference presentation transcripts neither referenced in the amended complaint nor

included in any public SEC filing. D. 32-13; D. 32-15. These documents “are not properly before

the Court, nor are they essential to evaluating the sufficiency of the [c]omplaint.” See Kader, 2016

WL 1337256, at *10 (granting motion to strike exhibits attached to declaration in support of

defendants’ motion to dismiss). Accordingly, the Court has not considered these three exhibits in

the resolution of the motion to dismiss.

B. Factual Allegations

The following facts are drawn from Plaintiff’s amended complaint, D. 26, and from the

exhibits Defendants filed in support of their motion, except Exhibits L, M and O, as discussed

above, see D. 32.

1. Bluebird plans to apply for FDA approval of LentiGlobin

Bluebird is a biotechnology company that develops gene therapies for severe genetic

diseases and cancer. D. 26 ¶ 6. The Company uses lentiviral vectors to introduce a functional

copy of a gene to a patient’s own stem cells ex vivo (i.e., outside the patient) and then the modified

stem cells with the functional gene are reinserted into the patient. Id. ¶¶ 29, 32. Bluebird’s gene

therapy programs in development include LentiGlobin for the treatment of sickle cell disease

(“LentiGlobin”). Id. ¶¶ 6, 30. Sickle cell disease (“SCD”) is a hereditary blood disorder with

significant negative health effects caused by a mutation in the beta-globin gene that results in

polymerized hemoglobin and abnormal red blood cell function. Id. ¶ 30. Currently, treatments

for the disease are limited to chronic blood transfusions and hydroxyurea, a generic drug. Id. ¶ 31.

LentiGlobin is designed to be a one-time treatment that would use bluebird’s lentiviral vector

platform to replace damaged cells’ mutated beta-globin genes, enabling SCD patients to form

normally functioning hemoglobin and normal red blood cells. Id. ¶¶ 32–33.

Bluebird announced plans to apply for FDA approval to market LentiGlobin. See id. ¶¶ 7,

53. If approved, LentiGlobin could be a “blockbuster therapy” for bluebird, with analysts

projecting peak global sales at $2.1 billion, nearly as much as all of bluebird’s other four products

in development combined. Id. ¶ 34.

The process for obtaining FDA approval to market a biological product generally involves:

(1) completion of nonclinical laboratory tests and animal studies; (2) submission of an application

for an investigational new drug; (3) performance of adequate and well-controlled human clinical

studies to establish the safety and efficacy of the product for its intended use; (4) submission of a

Biologics License Application (“BLA”) for marketing approval that includes evidence of safety,

purity and potency from results of nonclinical testing and clinical studies; (5) inspections of the

manufacturing facilities; (6) potential audit of nonclinical and clinical study sites; and (7) FDA

review and approval of the BLA. Id. ¶ 50.

To submit a viable BLA, an applicant must demonstrate both adequate clinical results and

the adequacy of its chemistry, manufacturing and controls (“CMC”) for production to the FDA.

Id. ¶ 9. Clinical studies of biological products are typically conducted in three sequential phases,

which may overlap or be combined. Id. ¶ 48. In Phase 1, the product is introduced into healthy

subjects and tested for safety. Id. In Phase 2, the product is evaluated in a limited patient

population preliminarily to evaluate the product’s efficacy and optimal dosage. Id. In Phase 3,

the product is evaluated in an expanded patient population at geographically dispersed clinical

study sites to establish the product’s overall risk-benefit ratio and provide an adequate basis for

product labeling. Id.

The FDA has published guidance regarding the development and submission of gene

therapy protocols, including on CMC-related issues. Id. ¶ 51. For example, in January 2020, the

FDA issued a final guidance document “to inform sponsors how to provide sufficient CMC

information required to assure product safety, identity, quality, purity, and strength (including

potency) of the investigational product.” Id. ¶ 52; see D. 32-7 at 4. The document includes

guidance on how gene therapy developers should account for changes in manufacturing processes

during product development, stating: “[i]f you make significant manufacturing changes, then

comparability studies may be necessary to determine the impact of these changes on the identity,

purity, potency, and safety of the product.” D. 26 ¶ 52; see D. 32-7 at 6. As with other FDA

guidance documents, this guidance “do[es] not establish legally enforceable responsibilities” but

instead “describe[s] the FDA’s current thinking on a topic and should be viewed only as

[providing] recommendations.” D. 32-7 at 5.

Bluebird has conducted multiple clinical studies for LentiGlobin, including a Phase 3 study

involving the treatment of patients with SCD that was ongoing in 2020. D. 26 ¶¶ 35–36. These

clinical studies used lentiviral vectors manufactured using an “adherent” process. Id. ¶ 37. In May

2020, bluebird announced that, for commercial purposes, it would shift to a “suspension-based”

manufacturing process. Id. ¶ 40. Baird explained that this process would enable the Company to

produce LentiGlobin more efficiently and at greater scale, which was “critical from both a cost of

goods perspective and a capacity perspective” and a “key component” to “financial sustainability.”

Id. ¶¶ 41–42; see D. 32-9 at 8, 20. Around that time, numerous competitors were also seeking to

develop gene treatment therapies and other alternative treatments for SCD. See D. 26 ¶¶ 39–40.

2. Bluebird announces accelerated approval timeline

On May 11, 2020, bluebird announced that it had reached “general agreement with FDA

that the clinical data package required to support a BLA submission for [LentiGlobin] will be

based on data from a portion of patients in the [Phase 1/2 clinical study] that have already been

treated.” Id. ¶ 54. Accordingly, the Company stated that it planned “to seek an accelerated

approval and expect[ed] to submit the [BLA] for sickle cell disease in the second half of 2021.”

Id. ¶ 55. Defendants repeated similar statements that day in SEC filings and an analyst conference

call. See, e.g., id. ¶¶ 59, 61, 63; D. 32-8 at 5; D. 32-9 at 6. When asked during the conference call

how the newly announced suspension manufacturing process would impact the BLA submission,

Leschly stated that “we don’t anticipate that standing in the way.” D. 26 ¶ 61; D. 32-9 at 20.

Bluebird simultaneously advised investors that it “anticipate[d] additional guidance from

FDA regarding the commercial manufacturing process, including suspension lentiviral vector.”

D. 26 ¶ 55; see D. 32-8 at 5. During the May 11, 2020 conference call, one bluebird representative

stated that “[t]he only other nuance . . . is to address alignment on CMC as well, and we have

planned engagements coming up to ensure that we’re aligned on that.” D. 32-9 at 10. Bluebird’s

quarterly SEC filing for the first quarter of 2020 noted that, because the Company was

“transitioning . . . to a scalable suspension process,” in seeking regulatory approval it “may need

to conduct additional studies to demonstrate comparability of the modified versions to earlier

versions.” D. 26 ¶ 65; D. 32-14 at 7. The filing further explained: “[w]e are engaged with

regulatory agencies on the data that we will be required to collect to demonstrate comparability.”

D. 32-14 at 7. Moreover, the filing cautioned that bluebird’s “ability to submit and obtain approval

of a BLA is ultimately an FDA review decision” and, “[d]epending on the outcome of these

ongoing clinical studies, the FDA may require that we conduct additional or larger pivotal trials

before we can submit or obtain approval for a BLA.” Id. at 8.

3. Bluebird announces public offering

The day after bluebird announced its “general agreement with FDA,” D. 26 ¶ 54, the

Company’s share price increased $0.95 on unusually high trading volume, id. ¶ 69. On May 18,

2020, one week after the announcement, bluebird commenced a public offering. Id. ¶ 73. In

connection with the offering, the Company filed a prospectus supplement, id. ¶ 74, which

confirmed that bluebird was “planning to seek an accelerated approval [for LentiGlobin] and

expect[ed] to submit the BLA for sickle cell disease in the second half of 2021,” id. ¶ 77.

Bluebird’s share price rose $0.48 on May 18, 2020 and another $7.27 on May 20, 2020 to close at

$65.17. Id. ¶ 74. Through the public offering, bluebird sold 10.5 million shares of common stock

at $55.00 per share, raising aggregate net proceeds of $541.5 million. Id. ¶ 75.

Bluebird previously reported in an SEC filing that it “has incurred losses since inception

and to date has financed its operations primarily through the sale of shares of the Company’s

stock.” Id. ¶ 71. It further stated that “[t]he Company expects to continue to generate operating

losses and negative operating cash flows for the next few years and will need additional funding

to support its planned operating activities through profitability.” Id.

4. Bluebird announces delayed submission of licensing application

On August 5, 2020, bluebird announced that it was transitioning to the new suspension

manufacturing process for LentiGlobin. See D. 32-10 at 8. Bluebird maintained its stance

regarding the LentiGlobin BLA submission timeline, announcing that it still intended to file its

application for regulatory approval in the second half of 2021. D. 26 ¶¶ 80, 84. The Company

again noted in a press release “the risk that our plans for submitting a BLA for LentiGlobin for

SCD may be delayed if the FDA does not accept our comparability plans for the use of the

suspension manufacturing process.” Id. ¶ 82. Similarly, the Company’s quarterly SEC filing

stated: “[d]epending on the outcome of our ongoing and planned studies, the FDA may require

that we conduct additional or larger clinical trials before our LentiGlobin product candidate is

eligible for approval for the treatment of patients with SCD.” D. 32-10 at 7. The filing further

cautioned that “[t]he FDA may not agree with our plans for demonstrating comparability of the

adherent manufacturing process to the suspension manufacturing for lentiviral vector, which may

result in delays in our ability to submit a BLA for regulatory approval of LentiGlobin.” D. 26

¶ 88; D. 32-10 at 7–8 (noting the possibility that FDA “may require us to conduct additional

studies, collect additional data, develop additional assays, or modify release specifications, which

may delay our ability to submit a BLA . . . for regulatory approval”).

On November 4, 2020, bluebird issued a press release stating that it no longer planned to

submit its BLA for LentiGlobin in the second half of 2021. D. 26 ¶ 103. Bluebird explained that,

with respect to the LentiGlobin comparability analysis, “FDA requested the use of drug product

manufactured from sickle cell disease (SCD) patient cells in addition to healthy donors as well as

commercial lentiviral vector to demonstrate drug product comparability.” Id. The Company stated

that this would push the BLA submission to late 2022. Id. On an analyst conference call that day,

Leschly said that, “[w]hile this interaction with the FDA confirmed the robustness of our clinical

data package and overall CMC confidence, the requirements to demonstrate comparability are . . .

different than the plan we proposed and expected.” Id. ¶ 104. Leschly further explained that this

change, along with COVID-19-related operational delays, caused the Company to “adjust[] the

timing of the BLA submission back to the more conservative initial target timing of late 2022.”

Id. When asked for more detail regarding the FDA’s rationale for requesting more comparability

data, bluebird’s chief medical officer, David Davidson, responded: “[i]n the past, we have used

healthy donor cells in terms of demonstrating comparability. . . . [O]ur hope had been that normal

volunteer cells would be acceptable given the robustness of the clinical data we’re seeing, so far.”

Id. ¶ 105. The Company’s chief technology and manufacturing officer, Derek Adams, further

stated: “[t]he presumption, I guess, would be that the healthy donor cells . . . clearly don’t allow

us to be able to check the actual resulting potency of the drug product. . . . I want to presume that

they are concerned about . . . checking the potency of the results . . . .” Id.

Following this announcement, bluebird’s stock price fell $9.72 per share, or 16.6%, to close

at $48.83 per share on November 5, 2020. Id. ¶¶ 5, 112.

IV. Procedural History

This class action was initiated on February 12, 2021 in the Eastern District of New York,

D. 1, and later transferred to this Court, D. 11. Plaintiff filed an amended complaint on July 6,

2021. D. 26. Defendants now have moved to dismiss. D. 30. The Court heard the parties on the

pending motion and took the matter under advisement. D. 38.

V. Discussion

A. Section 10(b) and Rule 10b-5 Claim (Count I)

To state a claim under Section 10(b) and Rule 10b-5, a plaintiff must adequately plead (1)

a material misrepresentation or omission, (2) scienter, (3) a connection with the purchase or sale

of a security, (4) reliance, (5) economic loss and (6) loss causation. Amgen Inc. v. Conn. Ret.

Plans & Tr. Funds, 568 U.S. 455, 460–61 (2013). Defendants challenge the adequacy of the

amended complaint’s allegations regarding scienter, actionable misrepresentations or omissions

and loss causation. D. 31 at 9–10.

1. Scienter

Defendants argue that Plaintiff has failed to allege facts supporting a strong inference of

scienter. Id. at 19–29. “Scienter is defined as either the ‘intentional or willful conduct designed

to deceive or defraud investors’ or ‘a high degree of recklessness.’” Metzler Asset Mgmt. GmbH

v. Kingsley, 928 F.3d 151, 158 (1st Cir. 2019) (quoting In re Biogen Inc. Sec. Litig., 857 F.3d 34,

41 (1st Cir. 2017)). Recklessness in this context refers to “a highly unreasonable omission”

involving “an extreme departure from the standards of ordinary care, and which presents a danger

of misleading buyers and sellers that is either known to the defendant or is so obvious that the actor

must have been aware of it.” Brennan v. Zafgen, Inc., 853 F.3d 606, 613 (1st Cir. 2017) (citation

and internal quotation marks omitted). This “definition of recklessness does not encompass

ordinary negligence and is closer to a lesser form of intent.” Greebel v. FTP Software, Inc., 194

F.3d 185, 199 (1st Cir. 1999). Defendants must have had the requisite scienter at the time of the

allegedly fraudulent statements. In re Ariad Pharms., Inc. Sec. Litig., 842 F.3d 744, 751–52 (1st

Cir. 2016).

The PSLRA’s requirement to plead facts giving rise to a “strong inference” of scienter

means that “[a] complaint will survive . . . only if a reasonable person would deem the inference

of scienter cogent and at least as compelling as any opposing inference one could draw from the

facts alleged.” Tellabs, 551 U.S. at 324. Thus, in evaluating securities class action complaints,

courts “must take into account plausible opposing inferences.” Id. at 323–24 (instructing courts

to “consider plausible, nonculpable explanations for the defendant’s conduct, as well as inferences

favoring the plaintiff”). This is necessarily a fact-specific inquiry, Aldridge v. A.T. Cross Corp.,

284 F.3d 72, 82 (1st Cir. 2002), which may rely upon indirect evidence of scienter, Greebel, 194

F.3d at 195, 202. Courts conducting such an inquiry must determine “whether all of the facts

alleged, taken collectively, give rise to a strong inference of scienter, not whether any individual

allegation, scrutinized in isolation, meets that standard.” Tellabs, 551 U.S. at 322–23 (emphasis

omitted).

a) Intentional or Reckless Disregard of Plan’s Deficiency

Plaintiff claims that Defendants intentionally or recklessly disregarded that the

comparability plan could not show the comparable potency of LentiGlobin when manufactured

using the suspension process because the plan did not involve using SCD patient cells. D. 34 at

24. For support, Plaintiff primarily relies upon alleged statements made by Derek Adams,

bluebird’s chief technology and manufacturing officer, on a November 4, 2020 analyst conference

call, D. 34 at 25; see D. 26 ¶ 105, and FDA guidance regarding the potential need for comparability

studies upon significant changes to manufacturing methods, D. 34 at 26; see D. 26 ¶ 52.

As Defendants argue, however, such allegations do not support that Defendants

intentionally or recklessly disregarded the comparability plan’s deficiency. See D. 31 at 22; D. 37

at 10–11. Derek Adams made his statements regarding the comparability plan’s ability to assess

potency after the FDA had already provided feedback on the plan. See D. 26 ¶ 105. In context,

Derek Adams’s statements attempted to explain the FDA’s position; they did not constitute an

admission of bluebird’s prior knowledge of the plan’s deficiency. See id. (stating that “[t]he

presumption, I guess, would be that the healthy donor cells . . . clearly don’t allow us to be able to

check the actual resulting potency of the drug product” and “I want to presume that they [i.e.,

FDA] are concerned about the potency”). Moreover, immediately prior to Derek Adams’s

statements, David Davidson, bluebird’s chief medical officer, explained: “[i]n the past, we have

used healthy donor cells in terms of demonstrating comparability. . . . [O]ur hope had been that

normal volunteer cells would be acceptable given the robustness of the clinical data we’re seeing,

so far.” Id. Taken together, these statements do not suggest that bluebird intentionally or

recklessly disregarded that the FDA would require use of SCD patient cells in its comparability

study. Instead, they indicate that bluebird believed prior to receiving the FDA’s feedback that

using healthy donor cells could demonstrate comparability.

Further, the non-binding FDA guidance cited by Plaintiff, id. ¶ 52; D. 34 at 26, also does

not support a strong inference of scienter. Such guidance noted that “[i]f you make significant

manufacturing changes, then comparability studies may be necessary to determine the impact of

these changes on the identity, purity, potency, and safety of the product.” D. 26 ¶ 52. Such does

not require manufacturers to conduct comparability studies, prescribe a way in which

comparability studies must be conducted or state that potency must always be tested in

comparability studies. See id. The guidance, therefore, does not support an inference that

Defendants intentionally or recklessly disregarded that not using SCD patient cells in the

comparability study would materially increase the risk of delay to the Company’s projected FDA

approval timeline.

As Defendants observe, D. 31 at 21; D. 37 at 8, the amended complaint does not otherwise

identify any admission, internal record, witnessed discussion or communication to suggest that

bluebird knew or was warned that its proposed comparability plan would be insufficient to support

a BLA, see generally D. 26. Without facts to support Plaintiff’s assertion that the FDA was “highly

likely to reject bluebird’s plan” because it “could not show comparable potency at all,” D. 34 at

26, such amounts to Plaintiff’s own scientific opinion, which is insufficient support a claim of

securities fraud. See Harrington v. Tetraphase, No. CV 16-10133-LTS, 2017 WL 1946305, at *5

(D. Mass. May 9, 2017) (stating that “scientific opinions are just that: opinions”); In re Sepracor,

Inc. Sec. Litig., 308 F. Supp. 2d 20, 35–36 (D. Mass. 2004) (rejecting scienter allegations based

upon “subjective scientific disagreements”); In re Medimmune, Inc. Sec. Litig., 873 F. Supp. 953,

966–67 (D. Md. 1995) (rejecting scienter allegations because “[m]edical researchers may well

differ over the adequacy of given testing procedures” and plaintiffs “pleaded no specific facts to

show why [d]efendants knew or should have known [their use of blinding in a study] to be a

problem”).

Plaintiff’s allegations, therefore, constitute a claim of “fraud by hindsight”—that is,

“‘contrast[ing] a defendant’s past optimism with less favorable actual results’ in support of a claim

of securities fraud.” ACA Fin., 512 F.3d at 62 (quoting Shaw v. Digital Equip. Corp., 82 F.3d

1194, 1223 (1st Cir. 1996)); see Corban v. Sarepta Therapeutics, Inc., 868 F.3d 31, 39 (1st Cir.

2017) (rejecting that “overly optimistic” announcement regarding likelihood of new drug

application being accepted constituted securities fraud in absence of prior knowledge); Ganem v.

InVivo Therapeutics Holdings Corp., 845 F.3d 447, 457 (1st Cir. 2017) (affirming dismissal where

plaintiff did not “point to any FDA requirement” supporting contention that company should have

known its projected timeline for submission of data was “impossible to achieve” and explaining

that defendant did not commit securities fraud by failing to have “greater clairvoyance” (citation

omitted)). In, for one example, Corban, the First Circuit affirmed the dismissal of a securities

fraud class action complaint for lack of a strong inference of scienter despite the FDA expressing

“serious concerns” to the company regarding the drug’s potential approval several months before

the relevant stock drop. Corban, 868 F.3d at 35, 38 (noting that the defendant’s “mix of optimism

and caution” “convey[ed] opinion more than fact” and “came replete with caveats”).

Here, Defendants received no such warning from the FDA but did similarly caution

investors. For one example, in announcing its plan to seek accelerated approval for LentiGlobin,

bluebird noted its “general agreement with FDA” regarding the sufficiency of its “clinical data

package” but also stated that it “anticipate[d] additional guidance from FDA regarding the

commercial manufacturing process, including suspension lentiviral vector.” D. 26 ¶¶ 54–55; see

D. 32-9 at 10; D. 32-14 at 8. The Company, therefore, informed investors that its alignment with

FDA was limited to the clinical data package. Bluebird also promptly disclosed the feedback it

received from the FDA regarding its comparability plan, informing investors on November 4, 2020

that “FDA requested the use of drug product manufactured from [SCD] patient cells in addition to

healthy donors as well as commercial lentiviral vector to demonstrate drug product comparability,”

pushing the BLA submission timeline to late 2022. D. 26 ¶ 103. Such “full and prompt disclosure

. . . further undercut[s] any inference of fraudulent intent.” In re Genzyme Corp. Sec. Litig., 754

F.3d 31, 42 (1st Cir. 2014); see Fire & Police Pension Ass’n of Colo. v. Abiomed, Inc., 778 F.3d

228, 243 (1st Cir. 2015) (stating that company’s prompt disclosure of FDA warning letter did not

represent “the actions of a company bent on deceiving investors as to their future earnings

prospects”).

Cases upon which Plaintiff relies do not support the allegations of scienter. See D. 34 at

25 (citing In re Illumina, Inc. Sec. Litig., No. 3:16-CV-3044-L-KSC, 2018 WL 500990, at *5

(S.D. Cal. Jan. 22, 2018); Todd v. STAAR Surgical Co., No. CV-14-05263-MWF-RZ, 2016 WL

6699284, at *14 (C.D. Cal. Apr. 12, 2016)). For example, Illumina concluded that the plaintiffs

adequately alleged scienter for false earnings guidance where the defendants forecasted a rise in

sales when they knew sales were in decline, despite that it remained “possible” that the defendants

believed the company could achieve its earnings guidance. Illumina, 2018 WL 500990, at *5.

There, the complaint alleged statements by the defendants indicating knowledge of declining sales.

Id. Here, by contrast, Plaintiff has alleged no such statements.

Further, Todd concluded that allegations that the defendants knew facts “produc[ing] a

sufficiently great possibility of a future [w]arning [l]etter” supported an inference of scienter.

Todd, 2016 WL 6699284, at *14. That case involved allegations indicating that the defendants

knew about adverse observations during FDA inspections and so could have anticipated receiving

a violation form and warning letter from the agency. Id. at *12. In concluding that the plaintiff

adequately pleaded scienter, the court noted alleged conversations between company management

and the FDA inspector explicitly referencing the violations, as well as the defendants’ familiarity

with FDA procedures given the company’s many past violations. Id. at *12–13. The case also

involved undisclosed, repeated negative feedback from confidential witnesses who reported to

management the substantial defects that ultimately formed the warning letter’s basis. Id. at *3–4.

Contrastingly, while the amended complaint here does cite Defendants’ “ample experience in the

field” and previous “manufacturing issues,” D. 26 ¶¶ 94–95, such is unlike the notice of warnings

from the regulator and substantial defects giving rise to same in Todd and fails to support a claim

of fraud. Cf. Whitehead v. Inotek Pharm. Corp., No. 17-CV-10025-LTS, 2018 WL 4732774, at

*4–5 (D. Mass. June 27, 2018) (rejecting argument that scienter could be inferred from defendants’

knowledge of “certain negative outcomes in earlier trials” because it was “certainly plausible” that

optimism regarding future of drug remained defendants’ “sincere view” and the plaintiff “alleged

no evidence that [made] the opposite inference as or more compelling”).

For all these reasons, Plaintiff’s argument that Defendants possessed the requisite scienter

based upon their intentional or reckless disregard for the comparability plan’s deficiency fails.

b) Motive and Opportunity

A “plaintiff may combine various facts and circumstances indicating fraudulent intent to

show a strong inference of scienter,” including allegations “that the defendants had the motive

(‘concrete benefits that could be realized by . . . the false statements and wrongful nondisclosures’)

and opportunity (‘the means and likely prospect of achieving concrete benefits by the means

alleged’) to commit the fraud.” Aldridge, 284 F.3d at 82 (alteration in original) (quoting Novak

v. Kasaks, 216 F.3d 300, 307 (2d Cir. 2000)) (further citation omitted). “[E]vidence of motive and

opportunity may establish a strong inference of scienter” but requires “additional factual support.”

See id.

According to Plaintiff, Defendants misled investors “to raise sorely needed capital” by

selling the Company’s stock at artificially inflated prices. D. 34 at 28. Bluebird previously

reported that it “has incurred losses since inception and to date has financed its operations primarily

through the sale of shares of the Company’s stock” and “expects to continue to generate operating

losses and negative operating cash flows for the next few years and will need additional funding

to support its planned operating activities through profitability.” D. 26 ¶ 71. Plaintiff, therefore,

argues that bluebird’s May 2020 public offering, which raised aggregate net proceeds of $541.5

million, was “critical for the Company” and provided a motive to commit fraud. D. 34 at 28; see

D. 26 ¶¶ 73–75.

Even assuming Plaintiff adequately pleads motive, Plaintiff still has not alleged sufficient

facts to establish a strong inference of scienter. Plaintiff cites Meyer v. Biopure Corp., 221 F.

Supp. 2d 195, 209 (D. Mass. 2002) for the proposition that specific allegations as to a defendant

company’s need to raise capital may establish motive. See D. 34 at 28. Meyer, however, also

noted that “evidence of motive and opportunity is not enough to create a blanket presumption that

any omissions were made with intent to defraud; there must be some other indication of knowledge

or a high degree of recklessness with respect to each act or omission,” which the plaintiff there

failed to allege. Meyer, 221 F. Supp. 2d at 209 (citing Aldridge, 284 F.3d 72, 82; Geffon v.

Micrion Corp., 249 F.3d 29, 36 (1st Cir. 2001) (asserting that “a plaintiff must allege some

additional misconduct from which a jury can draw a reasonable inference of intentional

deception”)); see Lenartz v. Am. Superconductor Corp., 879 F. Supp. 2d 167, 185–86 (D. Mass.

2012) (noting that the “mere statement” that a company obtained funding tied to an allegedly

inflated stock price is “insufficient to create a strong inference either of an intent to deceive or of

recklessness” (citation omitted)).

As concluded above, Plaintiff fails to allege facts indicating that Defendants intentionally

or recklessly disregarded the comparability plan’s deficiency in announcing the accelerated

approval timeline. The amended complaint, moreover, contains no allegations of insider trading,

a divergence between internal reports and public statements, bribery by top company officials,

significant GAAP violations or any other “factors that the First Circuit has found to support an

inference of scienter.” See Angelos v. Tokai Pharm., Inc., 494 F. Supp. 3d 39, 57 (D. Mass. 2020).

Accordingly, Plaintiff’s allegations of Defendants’ motive and opportunity fail to establish a strong

inference scienter absent additional allegations of intentional or reckless misconduct.

c) Core Operations Theory

Plaintiff further contends that a “core operations” theory supports a strong inference of

scienter. D. 34 at 32–33. Under such a theory, “facts critical to a business’s core operations . . .

are so apparent that their knowledge may be attributed to the company and its officers.” Crowell

v. Ionics, Inc., 343 F. Supp. 2d 1, 19 (D. Mass. 2004) (alteration and citation omitted). Courts,

however, “have been hesitant to apply significant weight to ‘core operations’ allegations without

other significant evidence of a defendant’s intent or recklessness, or a ‘plus factor.’” In re Biogen

Inc. Sec. Litig., 193 F. Supp. 3d 5, 51 (D. Mass. 2016), aff’d, 857 F.3d 34 (1st Cir. 2017) (quoting

In re A123 Sys., Inc. Sec. Litig., 930 F. Supp. 2d 278, 285 (D. Mass. 2013)). “As a general matter,

corporate 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.”

Metzler Asset Mgmt., 928 F.3d at 165 (quoting S. Ferry LP, No. 2 v. Killinger, 542 F.3d 776, 784–

85 (9th Cir. 2008)) (internal quotation marks and further citation omitted).

Plaintiff argues that the fact that “LentiGlobin stood to be by far bluebird’s most lucrative

development, and its most attractive offering for shareholders,” supports “a strong inference that

Leschly and Baird were directly involved in, or at least knowledgeable of,” the comparability plan.

D. 34 at 33; see D. 26 ¶ 34 (alleging that LentiGlobin could be a “blockbuster therapy” for

bluebird), ¶¶ 41–42 (alleging statements by Baird describing the suspension-based manufacturing

process as “critical”), ¶ 44 (alleging statements by Leschly describing same).

Even assuming Leschly and Baird’s knowledge of the suspension process as being critical

to LentiGlobin’s value proposition, such is insufficient to support that any one aspect of the

comparability analysis plan was so “apparent” that knowledge of such aspect “may be attributed

to the company and its officers.” See Crowell, 343 F. Supp. 2d at 19; see also Venkataraman v.

Kandi Techs. Grp., Inc., No. 20 CIV. 8082 (LGS), 2021 WL 4952260, at *4 (S.D.N.Y. Oct. 25,

2021) (stating that management “would not necessarily have known (as part of core operations of

the business) the test for what constitutes a related party under the applicable accounting rules”).

The Court cannot impute to Leschly and Baird knowledge of the comparability plan’s specific

deficiency “absent some additional allegation of specific information conveyed to management

and related to the fraud or other allegations supporting scienter.” See Metzler Asset Mgmt., 928

F.3d at 165 (citation and internal quotation marks omitted). Plaintiff has failed to allege

particularized facts as to such plus factor supporting that Leschly or Baird knew or should have

known that the FDA would request further comparability analysis, delaying LentiGlobin’s

approval timeline. Thus, Plaintiff’s core operations theory fails to support a strong inference of

scienter.2

d) Weighing Opposing Inferences

Considering the complaint as a whole, including “plausible opposing inferences,” Tellabs,

551 U.S. at 323, the strongest inferences favor Defendants. Plaintiff’s theory of scienter relies

upon the unsupported claim that the FDA was “highly likely to reject bluebird’s plan” because it

2 Following the motion hearing, Plaintiff filed a notice of supplemental authority arguing

that Construction Industry & Laborers Joint Pension Trust v. Carbonite, Inc., 22 F. 4th 1 (1st Cir.

2021), supports a strong inference of scienter here. D. 39. That decision, however, compels no

different outcome. Construction Industry concluded that the company’s view of the product at

issue as “important”—evidenced by “two specific plugs from top management”—supported a

strong inference of scienter. Id. at 9. But such inference of scienter was bolstered by other factors,

including that “it does not require a PhD to know that a product cannot be ‘super strong’ if it has

never once done what it is supposed to do” and internal reports stating that the product was not

ready for market. Id. at 9-10 (noting that “it is not enough to say that senior management would

have paid some attention to the product that they were raving about; the complaint must allege

particular facts strongly suggesting that that attention exposed them to information that either

rendered their public statements false or necessarily invited further investigation”). Here, Plaintiff

alleges no such “red flag[s].” See id. at 10.

The Court ALLOWS nunc pro tunc Defendants’ motion for leave to file a response to

Plaintiff’s notice of supplemental authority, D. 41, and also has considered that response, D. 41-1,

in resolving the motion to dismiss.

“could not show comparable potency at all.” D. 34 at 26. As concluded above, however, the

amended complaint fails to allege sufficient facts to support the claim that Defendants knew or

recklessly did not know that the plan would be rejected by the FDA for this deficiency. The

competing, nonculpable inference from the facts alleged—that bluebird designed a comparability

study it thought would be sufficient given that the FDA has not prescribed a specific method for

showing comparability and that bluebird used healthy donor cells to demonstrate comparability in

the past—is more compelling than Plaintiff’s proposed inference. Further, this nonculpable

inference is particularly strong given Defendants’ repeated disclaimers about the possibility that

the FDA would require additional studies or data collection, see Corban, 868 F.3d at 38–39, as

well as bluebird’s prompt disclosure of the agency’s feedback regarding the need for further

comparability analysis, see Fire & Police Pension Ass’n of Colo., 778 F.3d at 243; Genzyme, 754

F.3d at 42. Accordingly, Plaintiff fails to allege facts supporting a strong inference of scienter.

2. Actionable Misstatement or Omission

Defendants also argue that the amended complaint fails to allege an actionable

misstatement or omission on two grounds: (1) Plaintiff has not shown that Defendants made a

materially false or misleading statement or omission, D. 31 at 29–31, and (2) most of the alleged

misstatements are further immunized by the PSLRA’s “safe harbor” provisions, id. at 31–34.

a) Materially False or Misleading

“To establish a material misrepresentation or omission, [a plaintiff] must show ‘that

defendants made a materially false or misleading statement or omitted to state a material fact

necessary to make a statement not misleading.’” Ganem, 845 F.3d at 454 (quoting Geffon, 249

F.3d at 34). “Information is material if a reasonable investor would have viewed it as having

significantly altered the total mix of information made available.” Miss. Pub. Emps. Ret. Sys. v.

Boston Sci. Corp., 523 F.3d 75, 85 (1st Cir. 2008) (citations and internal quotation marks omitted).

The allegations in the complaint also must meet the standard under Fed. R. Civ. P. 9(b) and the

“heightened pleading requirements” imposed by the PSLRA. Id. Although “[i]n most

circumstances, disputes over the materiality of allegedly false or misleading statements must be

reserved for the trier of fact,” Shaw, 82 F.3d at 1217, dismissal is appropriate where “[t]he Court

finds that, even taking all facts alleged as true, most of the challenged statements were not material

misrepresentations or omissions,” Wasson v. LogMeIn, Inc., No. 18-cv-12330-ADB, 2020 WL

5946813, at *17 (D. Mass. Oct. 7, 2020). The Court also must dismiss a securities fraud complaint

“predicated on the concealment of information if that information was, in fact, disclosed.” In re

First Marblehead Corp. Sec. Litig., 639 F. Supp. 2d 145, 155 (D. Mass. 2009) (citations omitted).

None of Defendants’ alleged statements was materially false or misleading. Plaintiff

argues that Defendants misled investors by omitting that their comparability analysis plan entailed

using only healthy cells and could not demonstrate comparable potency. D. 34 at 34. As

Defendants contend, D. 31 at 29, however, and this Court concludes above, Plaintiff’s argument

amounts to a claim of “fraud by hindsight.” ACA Fin., 512 F.3d at 62. Plaintiff alleges no

contemporaneous facts demonstrating that bluebird knew or should have known that the FDA

would require further comparability analysis based upon the Company’s use of healthy patient

cells. Further, bluebird’s press releases, periodic reports and other statements cautioned that the

timing of its BLA submission might be delayed if the FDA required additional analysis. See, e.g.,

D. 26 ¶¶ 55, 65, 82; D. 32-10 at 7; D. 32-14 at 7. Because the facts alleged indicate that Defendants

disclosed to investors the relevant risk as understood at the time of disclosure, Plaintiff cannot

establish that Defendants’ statements were materially false or misleading. See First Marblehead

Corp., 639 F. Supp. 2d at 155.

b) Safe Harbor

The PSLRA’s “safe harbor” provisions further immunize Defendants’ statements. These

provisions “sharply limit liability of companies and their management for certain ‘forward-looking

statements,’ . . . when such statements are accompanied by appropriate cautionary language.” In re

Smith & Wesson Holding Corp. Sec. Litig., 669 F.3d 68, 71 n.3 (1st Cir. 2012) (citing 15 U.S.C.

§ 78u-5). Forward-looking statements include statements “of the plans and objectives of

management for future operations, including plans or objectives relating to the products or services

of the issuer.” Meyer, 221 F. Supp. 2d at 203 (quoting 15 U.S.C. § 78u-5(i)(1)(B)). “[T]o be

meaningful, cautionary statements must be ‘substantive and tailored to the specific future

projections, estimates or opinions . . . which plaintiffs challenge.’” Isham v. Perini Corp., 665

F. Supp. 2d 28, 39 (D. Mass. 2009) (quoting Smith & Wesson, 604 F. Supp. 2d at 340). Further,

“if a forward-looking statement is accompanied by meaningful cautionary language the

defendant’s state of mind is wholly irrelevant.” Leavitt v. Alnylam Pharms., Inc., 451 F. Supp. 3d

176, 186 (D. Mass. 2020) (citing In re Stone & Webster, Inc., Sec. Litig., 414 F.3d 187, 212 (1st

Cir. 2005)).

Here, Defendants’ alleged statements discussing potential FDA approval constituted

forward-looking statements. See, e.g., D. 26 ¶ 55 (stating that bluebird was “planning to seek an

accelerated approval” and “expect[ed] to submit” its BLA in late 2021); Leavitt, 451 F. Supp. 3d

at 186 (referring to challenged statements, “which discussed potential FDA approval,” as “typical

forward-looking statements” because they “anticipated a hoped-for future event, FDA approval”

and, therefore, “fit squarely within the [PSLRA’s] safe harbor”); In re Sanofi Sec. Litig., 87

F. Supp. 3d 510, 535 (S.D.N.Y. 2015), aff’d sub nom. Tongue v. Sanofi, 816 F.3d 199 (2d Cir.

2016) (noting that statements about FDA approval “are classically forward-looking—they address

what defendants expected to occur in the future”). Moreover, these statements were accompanied

by meaningful cautionary language. See, e.g., D. 32-14 at 7–8; Harrington, 2017 WL 1946305, at

*9 (concluding that “statements identify[ing] specific risk factors including . . . the possibility of

the FDA not approving the drug . . . is precisely what the law requires”).

Plaintiff argues that, “[w]hile Defendants accurately disclosed the nature of the risk—that

the FDA may not accept its plan, which may delay the LentiGlobin BLA submission”—

Defendants failed meaningfully to “disclose the high probability of the risk materializing because

they misleadingly omitted that bluebird’s comparability analysis plan could not show comparable

potency.” D. 34 at 37. Plaintiff cites Hill, in which the First Circuit stated that “[t]he omission of

a known risk, its probability of materialization, and its anticipated magnitude, are usually material

to any disclosure discussing the prospective result from a future course of action.” Hill, 638 F.3d

at 57 (quoting Lormand v. US Unwired, Inc., 565 F.3d 228, 248 (5th Cir. 2009)). Hill, however,

also noted that, “[t]o the extent that the plaintiff’s complaint is that the precise degree of risk was

not stated, that failure is not sufficient to have rendered the statements misleading.” Id. at 60

(stating that “where the level of risk is unknown and the existence of a risk is disclosed, we shall

hesitate to conclude that disclosure is misleading merely because it did not state that the risk was

‘serious’”).

Here, Defendants disclosed to investors the risk known at the time of the relevant SEC

filings, press releases and analyst conference calls. Plaintiff has not alleged sufficient facts to

support that a more precise degree of risk was, or should have been, known to Defendants prior to

the Company receiving the FDA’s feedback on its comparability analysis plan. Cf. Hill, 638 F.3d

at 60. Accordingly, Defendants’ forward-looking statements, accompanied by meaningful

cautionary language, fall within the PSLRA’s safe harbor.

For all these reasons, the amended complaint also fails to allege an actionable misstatement

or omission.

3. Loss Causation

The PSLRA provides that “the plaintiff shall have the burden of proving that the act or

omission of the defendant . . . caused the loss for which the plaintiff seeks to recover damages.”

15 U.S.C. § 78u-4(b)(4). Plaintiffs may establish loss causation by showing that a corrective

disclosure was “a ‘substantial’ cause of their losses.” See Mass. Ret. Sys. v. CVS Caremark Corp.,

716 F.3d 229, 237–39 (1st Cir. 2013) (quoting FindWhat Inv. Grp. v. FindWhat.com, 658 F.3d

1282, 1309 (11th Cir. 2011)). A “corrective disclosure” occurs when a company “release[s] . . .

information that reveals to the market the pertinent truth that was previously concealed or obscured

by the company’s fraud.” Id. at 237 (quoting FindWhat Inv. Grp., 658 F.3d at 1311–12); see

Coyne v. Metabolix, Inc., 943 F. Supp. 2d 259, 273 (D. Mass. 2013) (explaining that “the

announcement must connect the current, present, negative information to the earlier false or

misleading statement” (emphasis omitted)).

Plaintiff cannot show loss causation because he has not alleged any corrective disclosure.

Even assuming Plaintiff can connect bluebird’s November 4, 2020 announcement that the

Company planned to delay its BLA submission to the following day’s stock drop, D. 26 ¶¶ 103,

112, Plaintiff has not adequately alleged that Defendants “reveal[ed] to the market [a] pertinent

truth that was previously concealed or obscured by the company’s fraud.” See Mass. Ret. Sys,

716 F.3d at 237; In re Wayfair, Inc. Sec. Litig., 471 F. Supp. 3d 332, 350 (D. Mass. 2020)

(concluding that a press release “was not a ‘corrective disclosure’ because [p]laintiffs have not

adequately pleaded scienter, so there is no adequate allegation that the defendants ‘concealed’ or

‘obscured’ any information from the public”). The Company’s announcement that it had

“adjust[ed] the timing of the BLA submission back to the more conservative initial target timing

of late 2022,” D. 26 ¶ 104, did not correct some untruth about the previously projected timeline

but rather updated the Company’s projection based upon new information.

Plaintiff’s “zone of risk” theory, D. 34 at 38, fails for similar reasons. Under this theory,

Plaintiff contends that his losses were caused by the materialization of a concealed risk—that is,

the high probability of the risk that the FDA would require that bluebird conduct further

comparability analysis to show comparable potency under the suspension process. Id. at 38–39;

see Lentell v. Merrill Lynch & Co., 396 F.3d 161, 173 (2d Cir. 2005) (stating that “a misstatement

or omission is the ‘proximate cause’ of an investment loss if the risk that caused the loss was within

the zone of risk concealed by the misrepresentations and omissions alleged”). As noted above,

however, Defendants did not conceal the risk that the FDA could require additional comparability

analysis but disclosed that risk several times throughout the Class Period.

Accordingly, Plaintiff also fails to allege sufficient facts supporting loss causation.

B. Section 20(a) Claim (Count II)

Plaintiff claims that Leschly and Baird are individually liable under Section 20(a) of the

Exchange Act based upon their positions of control and authority within the Company. D. 26

¶¶ 135–40; D. 34 at 41–42. Section 20(a) imposes joint and several liability on “[e]very person

who, directly or indirectly, controls any person liable” for a securities fraud violation. 15 U.S.C.

§ 78t(a). Thus, to state a claim under Section 20(a), a plaintiff must allege a primary violation of

the Exchange Act. ACA Fin., 512 F.3d at 67 (stating that “[t]he plain terms of [S]ection 20(a)

indicate that it only creates liability derivative of an underlying securities violation”). Because

Plaintiff fails to plead a primary securities law violation, Plaintiff’s claim under Section 20(a)

against Leschly and Baird also fails.

C. Leave to Amend

Plaintiff requests that, if this Court determines that the amended complaint fails adequately

to state a claim for relief, Plaintiff be granted leave further to amend the complaint. D. 34 at 42.

Plaintiff observes that “the PSLRA does not alter the liberal amendment policy” of Rule 15(a). Id.

(quoting ACA Fin., 512 F.3d at 57). Such, however, does not justify granting Plaintiff’s request

for at least one reason, namely futility. See ACA Fin., 512 F.3d at 56 (noting that grounds for

denial of motion to amend include “futility of amendment”); Hatch v. Dep’t for Child., Youth &

Their Fams., 274 F.3d 12, 19 (1st Cir. 2001) (stating that “[w]here an amendment would be futile

or would serve no legitimate purpose, the district court should not needlessly prolong matters”

(quoting Correa-Martinez v. Arrillaga-Belendez, 903 F.2d 49, 59 (1st Cir. 1990)). Because

Plaintiff does not suggest “that new information has been discovered such that amendment would

not be futile,” see Sousa v. Sonus Networks, Inc., 261 F. Supp. 3d 112, 121 (D. Mass. 2017), the

request to amend is denied.

VI. Conclusion

For the foregoing reasons, the Court ALLOWS Defendants’ motion to dismiss, D. 30.

So Ordered.

/s/ Denise J. Casper

United States District Judge