Court Opinion

ID: 4198064
Source: CourtListenerOpinion
Date Created: 2017-08-22 20:00:42.553265+00
Date Added: 2024-06-11T14:40:34.489457
License: Public Domain

United States Court of Appeals
                        For the First Circuit

Nos. 15-2135, 16-1658

    MARK A. CORBAN, individually and on behalf of all others
   similarly situated; STEVE FLEISCHMANN, individually and on
            behalf of all others similarly situated;

                        Plaintiffs, Appellants,

   DANIEL BARADARIAN, individually and on behalf of all others
 similarly situated; BIJESH AMIN, individually and on behalf of
                  all others similarly situated;

                              Plaintiffs,

                                  v.

   SAREPTA THERAPEUTICS, INC.; CHRIS GARABEDIAN; EDWARD KAYE,

                        Defendants, Appellees,

                           SANDESH MAHATME,

                              Defendant.

          APPEALS FROM THE UNITED STATES DISTRICT COURT
                FOR THE DISTRICT OF MASSACHUSETTS

           [Hon. Indira Talwani, U.S. District Judge]

                                Before

                     Kayatta, Circuit Judge,
                   Souter, Associate Justice,*
                    and Stahl, Circuit Judge.

     * David H. Souter, Associate Justice (Ret.) of the Supreme
Court of the United States, sitting by designation.
     Stuart W. Emmons, with whom William B. Federman, Amanda B.
Murphy, and Federman & Sherwood were on brief, for appellants.
     Christopher G. Green, with whom Dalila Argaez Wendlandt,
Justin G. Florence, Mark D. Vaughn, Alexia R. De Vincentis, and
Ropes & Gray LLP were on brief, for appellees.

                        August 22, 2017
          KAYATTA, Circuit Judge. The price of the publicly traded

securities issued by Sarepta Therapeutics, Inc. dropped sixty-four

percent   when     Sarepta     announced         that   the    Food    and   Drug

Administration deemed premature Sarepta's application for approval

of a novel gene therapy. Promptly thereafter, several shareholders

brought this securities fraud class action against Sarepta as well

as former and current Sarepta executives on behalf of those who

bought Sarepta stock during the prior four months while Sarepta

was expressing conditional optimism that the FDA would accept its

application.     The district court found that the plaintiffs failed

to allege facts creating a strong inference that the defendants

intentionally or recklessly deceived the investing public.                     We

agree and affirm.

                                        I.

                                        A.

          The district court dismissed the complaint after this

action was consolidated and the pleading was once amended.                    The

plaintiffs then brought a motion for leave to file another amended

complaint,   which   the     district    court     denied     as   futile.    The

plaintiffs     thereafter     brought        a   motion     for    relief    under

Rule 60(b)(2) of the Federal Rules of Civil Procedure proposing a

fourth version of the complaint, and a motion for reconsideration

under Rule 59(e) proposing yet a fifth version. The district court

denied all of these motions for the sole reason that it found them

                                   - 3 -
futile because none of the proposed pleadings sufficiently stated

a claim under the Private Securities Litigation Reform Act of 1995

(PSLRA), 15 U.S.C. § 78u–4(b).1       Normally we apply a deferential

standard of review to decisions denying amendment, relief from

judgment, and reconsideration.       Here, though, each ruling hinged

on a single issue:      the sufficiency of the pleading as a matter of

law.       Hence, our review is de novo.    See Mills v. U.S. Bank, NA,

753 F.3d 47, 54 (1st Cir. 2014); Roger Edwards, LLC v. Fiddes &

Son Ltd., 427 F.3d 129, 132 (1st Cir. 2005).           Because the fifth

version of the complaint is the most recent and most complete

version of the pleading, we focus our analysis on that iteration

and draw the following facts and reasonable inferences from it.

                                    B.

              Sarepta is a biopharmaceutical company that works to

discover and develop gene therapies for the treatment of rare

neuromuscular      diseases,   including   Duchenne   muscular   dystrophy

("DMD").       DMD is a progressive childhood disease that affects

       1The district court actually denied the motion for
reconsideration through an electronic order that does not furnish
the basis for the decision. Although "a short recitation of [the
district court's] reasoning" would have been preferable, "this
omission alone is not a basis for reversal" because "its reasons
are apparent from the record."    United States ex rel. Kelly v.
Novartis Pharm. Corp., 827 F.3d 5, 10 (1st Cir. 2016). In any
event, deeming the denial to have been for futility favors the
plaintiffs, who not surprisingly urge us to so regard the order
and to resolve the question of the complaint's sufficiency rather
than vacating and remanding to the district court for a statement
of reasons.

                                   - 4 -
approximately       1    in    3500    boys    worldwide.       Caused    by     genetic

mutations    that       hinder    or    halt     production     of   dystrophin,      an

essential protein for muscle function, DMD leads to loss of muscle

strength and ultimately to respiratory and cardiac failure.                         Few

boys afflicted with this debilitating disease reach adulthood.

            Sarepta's lead product candidate during the relevant

time period was eteplirsen.              Eteplirsen is designed to treat DMD

by altering the transcription process to skip the genetic mutation.

It    thereby    enables       the     body's    production     of     truncated     but

functional dystrophin, the type of dystrophin associated with less

severe forms of muscular dystrophy and longer life expectancies.

            To     market      eteplirsen       in   the   United    States,     Sarepta

needed approval from the FDA.                  The approval process requires a

sponsor like Sarepta to prepare and submit a new drug application

("NDA" or "application").              See 21 U.S.C. § 355(a).           When the FDA

receives an NDA, it "ma[kes] a threshold determination [whether]

the NDA is sufficiently complete to permit a substantive review."

21 C.F.R. § 314.101(a)(1).             If so, the FDA accepts the application

for filing.        Id.        The agency then assesses the merits of the

application,       deciding       whether       to    approve    the     drug.       Id.

§    314.101(f).        Approval       generally     requires    the    application's

sponsor to demonstrate the drug's clinical benefit.                     See 21 U.S.C.

§ 355(d).       In certain instances, though, an accelerated approval

program permits the FDA to review and approve "a product for a

                                          - 5 -
serious or life-threatening disease or condition . . . upon a

determination that the product has an effect on a surrogate

endpoint that is reasonably likely to predict clinical benefit."

Id. § 356(c)(1)(A).     For example, even if a sponsor has not yet

shown that a drug reduces the occurrence of stroke, the FDA might

fast-track the drug upon a showing that it has a measurable effect

on blood pressure.      See U.S. Food & Drug Admin., FDA Facts:

Biomarkers and Surrogate Endpoints, https://www.fda.gov/aboutfda/

innovation/ucm512503.htm (last updated July 22, 2016).

             Sarepta set its sights on accelerated FDA approval for

eteplirsen, developing and conducting a series of clinical trials

to investigate the drug's effect on two endpoints:         (1) the

percentage change in dystrophin-positive fibers in the patient's

muscle, and (2) the distance the patient was able to walk in six

minutes.   The clinical trials most relevant to this litigation are

Sarepta's Phase IIb clinical trials, Study 201 and Study 202.

Study 201 enrolled twelve boys in a randomized, double-blind,

placebo-controlled trial.     Four boys received a placebo, another

four received a lower dose of eteplirsen, and four more received

a higher dose of the drug.      After twenty-four weeks, Study 202

commenced.    In this open-label extension, which was neither blind

nor placebo-controlled, all twelve participants received the drug

in one dosage or the other.

                                - 6 -
              Pointing to the results of these trials, in March 2013,

Sarepta informed investors that it would move toward filing an

NDA.    To that end, Sarepta met with FDA officials that month.

During the meeting, the FDA expressed serious concerns regarding

the way Sarepta proposed to analyze the results from the Phase IIb

trials, cautioning that "the proposed analysis was unreasonable

even    for    hypothesis      generation."      Sarepta     relayed   certain

information about this meeting to analysts and investors during an

April 15, 2013 conference call led by Chris Garabedian, President

and Chief Executive Officer of Sarepta at the time, and Edward

Kaye, then the company's Senior Vice President and Chief Medical

Officer.      Garabedian explained that the FDA had "not made a final

decision"--and that it was "still too early to draw conclusions"

about the FDA's stance--regarding Sarepta's proposed dystrophin

endpoint      for   accelerated      approval.   He    nonetheless     conveyed

optimism and a sense of positive momentum on this call, stating

that the FDA was "approaching the question of [d]ystrophin as a

surrogate that is reasonably likely to predict clinical benefit in

the    thoughtful     manner    we    expected   and   is    requesting   more

information."       Garabedian struck a similar tone at a conference

presentation on July 10, 2013.

              Approximately two weeks later, on July 23, 2013, Sarepta

again met with the FDA regarding eteplirsen.                By this time, the

FDA had reviewed additional information from Sarepta about its

                                       - 7 -
data.    The agency told Sarepta at the July meeting that it was

"open to considering an NDA based on these data for filing,"

subject to a number of conditions.                Sarepta quoted that language

in a press release it issued the following day, which also stated

that Sarepta planned to submit an NDA "in the first half of 2014

for the approval of eteplirsen."              The press release went on to say

that the FDA "requested additional information related to the

methodology and verification of dystrophin quantification," and

that the company believed it could address and incorporate the

requests into its early 2014 submission.                In calls with analysts,

investors,      and       business       reporters,    Garabedian    communicated

"excite[ment]," stating that the company was "very encouraged by

the FDA feedback" and hopeful that the agency "would accept [an

NDA]    for   filing."         He     emphasized      Sarepta's   "belie[f]       that

dystrophin     is     a   viable     surrogate    marker,"    characterizing      the

company's dystrophin analysis as "robust."

              Notwithstanding        Garabedian's      sanguinity,      the    company

cautioned in its communications that the exact timing of the NDA

submission was unknown, that the agency did not yet endorse the

dystrophin     surrogate      endpoint       under    the   accelerated       approval

pathway, and that in any event "[a] filing would only indicate

that    the   question      [of    the    propriety    of   Sarepta's    dystrophin

surrogate endpoint] merits review."                   Investors apparently paid

more attention to those caveats than to the news that the FDA was

                                          - 8 -
open to considering an NDA based on Sarepta's Phase IIb trial data,

as Sarepta's stock price dropped nineteen percent on July 24 from

its closing price the day before.                   Nevertheless, as we will

describe in greater detail, the plaintiffs contend that Sarepta's

July 24 communications were misleadingly rosy and selectively

omitted further detail that would have better conveyed a picture

of a highly dubious FDA.                 The plaintiffs therefore point to

July 24, 2013, as the beginning of the time period during which

class members were defrauded.

               During the ensuing months leading up to the November

2013 stock drop, the defendants made several additional comments

challenged by the plaintiffs.              For example, Garabedian heralded

Sarepta's progress toward approval as "a tremendous achievement,"

described the company's data set as "compelling and favorable,"

and characterized the FDA's feedback as "particularly encouraging

because    it    recognizes     that     our   Phase       IIb   study   data    set   is

sufficient       for   the   FDA   to    consider      a    filing."       At    another

presentation, he called the FDA's response at the July meeting the

"type     of    information     that     every    company        hopes    for."        He

subsequently described Sarepta's dystrophin analysis as "a very

rigorous,       measured     approach"    which   "produced        the    most    robust

[dystrophin] data set of any [dystrophin]-producing technology"

and was not "questioned or challenged [by the FDA] in terms of

[Sarepta's] method for quantifying [dystrophin]."                        And he opined

                                         - 9 -
that the FDA's request for additional muscle biopsies of the study

participants "was not an indication of the lack of strength of

[Sarepta's] current biopsy analysis and data."

          At the end of September 2013, a competing drug candidate

for the treatment of DMD "total[ly] fail[ed]" during a Phase III

trial notwithstanding promising Phase II results.     Drisapersen,

developed by Prosena and GlaxoSmithKline, relied on the "same

mechanism of action" as eteplirsen.    It had achieved "the coveted

'Breakthrough Designation' from [the] FDA" on account of "its

preliminary efficacy and potential." Yet in its "pivotal Phase III

trial," it "failed to meet its primary endpoint . . . and all

secondary endpoints."   This news initially boosted Sarepta stock,

as it "essentially g[ave] the entire DMD market to eteplirsen."

Yet some investors predicted that drisapersen's failure spelled

trouble for Sarepta.    Such trouble came to pass on November 12,

2013, when Sarepta divulged the FDA's most recent guidance: Citing

the drisapersen failure, the FDA stated that it viewed "an NDA

filing for eteplirsen as premature."      This news precipitated a

sixty-four percent plummet in Sarepta's stock price, and the

plaintiffs say it revealed that the defendants' representations

since late July had been fraudulent.

          After Sarepta announced the FDA's judgment that a filing

was premature, the dialogue between Sarepta and the FDA continued.

Public disclosures about their back and forth were largely one-

                              - 10 -
sided:    As the FDA later explained, "[b]ecause of laws governing

trade secret[s], [the] FDA is generally unable to provide any

information to the public about its finding regarding drugs under

development and is unable to comment about information provided by

the drug developer."      On a few occasions, however, FDA officials

made public statements about concerns they had communicated to

Sarepta   (without    always    specifying   when   those   communications

occurred).     Sarepta ultimately submitted its NDA in June 2015.

The FDA accepted the NDA for filing on August 25, 2015, and it

granted accelerated approval for eteplirsen on September 19, 2016.

By that time, this litigation was well underway.

                                     C.

             Two and a half months after the November stock drop, the

plaintiffs filed this putative class action complaint in which

they seek relief on behalf of all those who acquired Sarepta stock

between July 24, 2013 and November 11, 2013 (the "class period").

According to the relevant complaint, Sarepta and its top executives

perpetrated securities fraud under section 10(b) of the Securities

Exchange Act of 1934 (Exchange Act), 15 U.S.C. § 78j(b), and the

Securities     and   Exchange   Commission's   Rule   10b–5,    17   C.F.R.

§ 240.10b–5.    The complaint also charges the individual defendants

with liability for the alleged securities fraud under section 20(a)

of the Exchange Act, 15 U.S.C. § 78t(a).       The complaint avers that

the defendants overstated the significance of Sarepta's eteplirsen

                                   - 11 -
data and exaggerated the likelihood that the FDA would accept an

NDA for filing, thereby deceiving the investing public and causing

the purchase of Sarepta securities at inflated prices.

                                         II.

                                          A.

               "To successfully state a securities fraud claim under

section 10(b) and Rule 10b-5, a plaintiff must adequately allege,

among other things, scienter."            Local No. 8 IBEW Ret. Plan & Tr.

v.    Vertex    Pharm.,    Inc.,   838    F.3d    76,   80   (1st    Cir.   2016).

Adequately alleging this mental state, which "embrac[es] intent to

deceive, manipulate, or defraud," Aldridge v. A.T. Cross Corp.,

284    F.3d    72,   82   (1st   Cir.   2002)    (quoting    Ernst   &   Ernst   v.

Hochfelder, 425 U.S. 185, 193 n.12 (1976)), requires the plaintiff

to plead "either that the defendants consciously intended to

defraud, or that they acted with a high degree of recklessness,"

id. (citing Greebel v. FTP Software, Inc., 194 F.3d 185, 198-201

(1st Cir. 1999)).         That degree of recklessness demands "a highly

unreasonable omission," one that not only involves "an extreme

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."    In re Smith & Wesson Holding Corp. Sec. Litig., 669 F.3d 68,

77 (1st Cir. 2012) (quoting Miss. Pub. Emps.' Ret. Sys. v. Bos.

Sci. Corp., 649 F.3d 5, 20 (1st Cir. 2011)).                 Under this strict

                                        - 12 -
recklessness standard, "simple, or even inexcusable negligence"

does not suffice.         Id. (quoting Miss. Pub. Emps.' Ret. Sys., 649

F.3d at 20).

               To    decide   whether   the      complaint    adequately     alleges

scienter, "we eschew the ordinary standards of Federal Rule of

Civil Procedure 8(a)(2)," Vertex, 838 F.3d at 81, and instead apply

the "[e]xacting pleading requirements" imposed by Congress in the

PSLRA.     Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S.

308,     313    (2007).       "Under     the     PSLRA's     heightened     pleading

instructions, any private securities complaint alleging that the

defendant made a false or misleading statement must . . . 'state

with particularity facts giving rise to a strong inference that

the defendant acted with the required state of mind.'"                    Id. at 321

(quoting 15 U.S.C. § 78u–4(b)(2)).                 Although "Congress left the

key term 'strong inference' undefined," id. at 314, the Supreme

Court has explained that our inquiry is comparative:                        We must

determine whether "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."                    Id. at 324.

                                           B.

                                           1.

               The    complaint    focuses       much   on     Sarepta's     reports

regarding its July 23 meeting with the FDA, including the company's

July 24 press release and related comments by its officers.

                                        - 13 -
According to the complaint, these communications constitute the

opening salvos of fraud because Sarepta disclosed too little of

what FDA officials said at the July and March meetings, and painted

too rosy a picture of their reaction to Sarepta's data.                           The

plaintiffs      point    to   statements    by   Garabedian       that     he     was

"encouraged by the feedback from the FDA," that he believed "that

data   from    [Sarepta's]    ongoing    clinical   study     .   .   .    will    be

sufficient for an NDA filing," and that the FDA indicated that it

was "open to considering an NDA filing based on the data [Sarepta

had] shared with [the FDA] to date."         These and similar statements

were misleading, the plaintiffs say, because FDA officials also

voiced "a number of concerns" to be addressed prior to filing, and

articulated "strong reservations" about the type of data upon which

Sarepta was relying.

              The challenged statements that mark the beginning of the

class period provide poor material for building a fraud claim.

They convey opinion more than fact. And while opinion that implies

false facts may nonetheless suffice, see In re Credit Suisse First

Bos. Corp., 431 F.3d 36, 47 (1st Cir. 2005) ("[A] statement of

opinion may be considered factual . . . as a statement about the

subject   matter    underlying     the   opinion."),    overruled         on    other

grounds by Tellabs, Inc., 551 U.S. 308, these opinions came replete

with   caveats.         Sarepta   made   clear   that   the   FDA     "requested

additional information related to the methodology and verification

                                    - 14 -
of dystrophin quantification" and "would not commit to declaring

dystrophin an acceptable surrogate endpoint," and that a decision

to allow the filing of an NDA "would not indicate that [the FDA

had] accepted dystrophin expression as a biomarker reasonably

likely   to    predict   clinical   benefit."    Garabedian      accurately

reported that the FDA declined to offer "any guarantee or assurance

that an NDA submission would be acceptable for filing."              After

this mix of optimism and caution was communicated to investors on

July 24, Sarepta's stock dropped nineteen percent.

              Three   weeks   later,   the   company   further     reminded

investors that it had been trying to convince the FDA that its

method for quantifying dystrophin was acceptable and preferable.

And Kaye acknowledged that the company's data set was "limited."

Even if these and other caveats could have been more fulsome, they

cut against the inference of scienter.           See Geffon v. Micrion

Corp., 249 F.3d 29, 37 (1st Cir. 2001) (finding insufficient

evidence of scienter where company "sought to provide investors

with adequate warnings," even though "[p]erhaps [the company]

could have provided still more information about the specifics").

At worst, there was positive spin that put more emphasis in tone

and presentation on the real signs of forward movement with the

NDA than it did on causes for wondering if the journey would prove

successful.

                                    - 15 -
           Nor did the class period end in any manner that supports

an inference of fraud.    Progress toward realizing an optimistic,

albeit caveated, prediction markedly slowed, due at least in part

to a material development that occurred well after the prediction

was   proffered--i.e.,   the   failure   of   the   GlaxoSmithKline   and

Prosena product, drisapersen.       While the November announcement

demonstrated that the caveated hopes voiced in the time since the

July meeting had proven overly optimistic, there is nothing in

this chronology to suggest that Sarepta knew prior to November

that its efforts would suffer a setback at that time.        See Suna v.

Bailey Corp., 107 F.3d 64, 68 (1st Cir. 1997) ("[O]ptimistic

predictions about the future that prove to be off the mark . . .

are immunized unless plaintiffs meet their burden of demonstrating

intentional deception." (quoting Serabian v. Amoskeag Bank Shares,

Inc., 24 F.3d 357, 361 (1st Cir. 1994), abrogated on other grounds

by Greebel, 194 F.3d at 196-97)).         Sarepta's hopes, moreover,

ultimately proved correct, although on a much slower schedule.

The company submitted its NDA in June 2015, and the FDA accepted

the NDA for filing in August 2015.        In summary, the plaintiffs

mine little more than opinions, predictions, caveats, and cramped

disclosures in the events bookending the class period.

                                  2.

           That leaves the plaintiffs' arguments regarding a pair

of statements made by Garabedian in the middle of the class period.

                                - 16 -
First, on August 15, 2013, Garabedian stated that Sarepta had

shared its dystrophin data with the FDA (which is not disputed)

and that the data "was not something that was questioned or

challenged    in   terms   of   [Sarepta's]     method    for    quantifying."

Second, on September 9, 2013, he said in reference to the FDA's

proposal to conduct additional biopsies of the Phase IIb study

participants that the proposal "was not an indication of the lack

of strength of [Sarepta's] current biopsy analysis and data."2

According to the plaintiffs, these statements were "objectively

and knowingly false" because the FDA had communicated concerns

about the data analysis to Sarepta and Garabedian had knowledge of

such communications when he spoke.            Specifically, the plaintiffs

point to March 2013 communications from the FDA expressing the

agency's skepticism about Sarepta's quantification of dystrophin.

             Chronology    defeats    this    argument.     The       March   2013

communications     predated     Garabedian's       August       and    September

statements by several months.         In the intervening period, Sarepta

submitted additional data to the FDA in compliance with FDA

requests, and the agency's skepticism was fairly viewed as having

     2 These are the only two alleged misstatements after the
beginning and before the end of the class period that the
plaintiffs discuss in support of their argument that the defendants
could not have acted negligently and must have acted intentionally
or recklessly. They are, accordingly, the only two we consider.
See Rodríguez v. Municipality of San Juan, 659 F.3d 168, 175 (1st
Cir. 2011).

                                     - 17 -
diminished.     As the complaint's allegations show, it was after

reviewing the additional data that the FDA declared in July 2013

that it was "open to considering an NDA based on these data for

filing."      There is nothing in the complaint's allegations to

indicate that the strength of the concerns expressed by the FDA in

March 2013 persisted or that Garabedian understood the force of

those concerns to have survived additional data submissions (much

less the later and significantly more specific feedback provided

to Sarepta at the July 2013 meeting).

           Perhaps      sensing    this      flaw   in   the    timeline,    the

plaintiffs offer a second reason why Garabedian's statements were

"objectively and knowingly false."            They claim that the FDA told

Sarepta at the July 23 meeting that it doubted the validity of

Sarepta's method for quantifying dystrophin.                   To support this

claim, they rely on the FDA's expression of concern that there was

possible bias in the dystrophin analysis.                This perception of

possible   bias   was    based    not   on    any   specific    indication   or

allegation of bias, but rather on the general observation that

"all muscle biopsies were obtained and processed by a single

technician at a single study center."               Hence, the FDA felt that

another analysis by an independent laboratory was advisable.3 This

     3 The FDA's suggestion had to do with confirming existing
data, rather than generating additional data. For that reason, we
see no logical connection between it and Garabedian's September 9,
2013 statement about the FDA's proposal to conduct additional

                                   - 18 -
is far from evidence that the FDA "questioned or challenged"

Sarepta's data due to the company's "method for quantifying."            At

most, it demonstrates that an undifferentiated fear about the

latent risk of bias led the FDA to suggest a cautious approach:

confirming the results at an independent laboratory.              Concerns

about reliability are not the same as concerns about methodology,

and the plaintiffs' efforts to collapse these concepts in order to

demonstrate scienter fall flat.          Finally, even if Garabedian's

statements may have been misleading (an issue we need not decide),

the allegations cited by the plaintiffs do not adequately plead

that he intentionally or recklessly misled.

           The defendants had no legal obligation to loop the public

into each detail of every communication with the FDA.              "[M]ere

possession of . . . nonpublic information does not create a duty

to disclose it," In re Smith & Wesson Holding Corp. Sec. Litig.,

669 F.3d at 74 (first alteration in original) (quoting Hill v.

Gozani,   638   F.3d   40,   57   (1st   Cir.   2011)),   even   when   that

information is "material"--i.e., substantially likely to be viewed

by a reasonable investor as "significantly altering the total mix

of information made available," id. (citing City of Dearborn

Heights Act 345 Police & Fire Ret. Sys. v. Waters Corp., 632 F.3d

biopsies of the Phase IIb study participants.      We therefore
understand the plaintiffs to offer the FDA's July 2013 concerns
about bias only as evidence that Garabedian's August 15, 2013
statement was knowingly false.

                                   - 19 -
751,    756   (1st     Cir.       2011)).       Of    course,   a   company    may   not

intentionally         or       recklessly      omit    facts    without   which      its

statements become misleading.                 Id.; see also 17 C.F.R. § 240.10b-5

(making it unlawful to "omit to state a material fact necessary in

order    to    make        the     statements     made,   in    the   light     of   the

circumstances under which they were made, not misleading").                          But

simply pointing us to omitted details, as the plaintiffs have done,

and failing to explain how the omitted details rendered the

particular disclosures misleading, misses the mark.                            That the

defendants neglected to mention specific factors (many of them

intricate and technical) contributing to the FDA's position, while

nonetheless faithfully representing that position (indeed quoting

directly from FDA sources at times), strikes us as more consistent

with negligence than reckless or intentional concealment.

              In advocating otherwise, the plaintiffs point to Zak v.

Chelsea Therapeutics International, Ltd., 780 F.3d 597 (4th Cir.

2015).    In Zak, a split panel of the Fourth Circuit vacated the

district court's decision that the complaint failed to adequately

plead scienter.        Id. at 611.           The court announced a narrow holding

and emphasized that "the scienter inquiry necessarily involves

consideration of the facts and of the nature of the alleged

omissions or misleading statements within the context of the

statements     that        a     defendant    affirmatively     made."        Id.    The

defendants in Zak had allegedly buried the lede, claiming that the

                                             - 20 -
FDA had "agreed" that the company's new drug application could be

submitted based on data from a single study and would not require

additional efficacy studies, when in fact FDA officials had told

the company "that a single successful study typically was not

sufficient to support approval of a new drug."                   Id. at 602.   Even

more egregiously, the defendants--while they possessed, but before

they     made     public,     an    FDA        briefing     document     including

recommendations against approval--issued a press release that

failed   to     disclose    those   recommendations        and    instead   falsely

represented the briefing document as surfacing only "lines of

inquiry."       Id. at 603.    In these respects, Zak is less like this

case and more like Schueneman v. Arena Pharmaceuticals, Inc.,

another out-of-circuit decision cited by the plaintiffs in their

briefing that is readily distinguishable.                 See 840 F.3d 698, 702,

708    (9th   Cir.   2016)    (finding     that    plaintiff      adequately   pled

scienter where company reported "favorable results on everything"

from animal studies and conveyed optimism about FDA approval while

concealing strong indications that drug caused cancer in rats).

                                          3.

              That brings us to the plaintiffs' argument that Sarepta

had a motive to lie, and that its motive supports an inference of

scienter.     The plaintiffs point to allegations about the company's

July 2013 "At the Market" offering, which allowed Sarepta to sell

up to $125 million of common stock at market price, as evidence of

                                     - 21 -
motive.    The complaint quotes the company's announcement that it

"intend[ed] to use any proceeds from this offering for general

corporate purposes," some related to eteplirsen and some not.

According to the complaint, "[h]ad the market been aware of these

undisclosed facts, investors would not have been so willing to

participate in the [at-the-market] offering, at least not at the

prices they paid."      Drawing on these allegations, the plaintiffs

argue that the offering provides strong evidence of motive, and

therefore scienter, because the defendants "needed the offering to

provide Sarepta essential funding."

            "[T]he usual concern by executives to improve financial

results"   does   not   support   an   inference   of   scienter.   In   re

Cabletron Sys., Inc., 311 F.3d 11, 39 (1st Cir. 2002); see also

Greebel, 194 F.3d at 197 ("[C]atch-all allegations that defendants

stood to benefit from wrongdoing . . . are [not] sufficient."

(third alteration in original) (quoting In re Advanta Corp. Sec.

Litig., 180 F.3d 525, 535 (3d Cir. 1999))).         We require something

more than the ever-present desire to improve results, such as

allegations that "the very survival of the company w[as] on the

line."    In re Cabletron Sys., Inc., 311 F.3d at 39.        The complaint

lacks such allegations, noting only that Sarepta depended heavily

on financing activities for capital.          Contrary to the district

                                  - 22 -
court cases cited by the plaintiffs,4 where the companies' finances

were in dire straits, the complaint alleges that "Sarepta had

$156.2 million in cash and cash equivalents on its balance sheet,"

and "$80 million in working capital," when it launched the July

2013       at-the-market       offering.        Lacking     are   any    allegations

suggesting      that    such     capital   was    insufficient        for   continued

operations, much less that Sarepta would shutter its doors unless

it padded earnings by deceiving investors.

              Beyond the financial motive, the plaintiffs say, Sarepta

had    reason    to    spark    false   hope:      It     catalyzed     families   and

advocates of boys suffering from DMD to pressure the FDA for

accelerated approval.           The plaintiffs point to remarks by various

FDA officials regarding "[g]reat hope" and "considerable public

attention" resulting from Sarepta's teasers about trial results.

       4
       In In re Ibis Technology Securities Litigation, the district
court found sufficient allegations of scienter in part because the
complaint averred that a contemporaneous stock offering "was
necessary to ensure that [the company] would not run out of cash
and could fund ongoing operations."      422 F. Supp. 2d 294, 317
(D. Mass. 2006). And in Frater v. Hemispherx Biopharma, Inc., the
district court held that scienter was adequately pleaded in part
because the complaint alleged that the company "was . . .
sufficiently short on cash at the time of the alleged
misrepresentations that it could not afford to finance an
additional clinical trial as the FDA had recommended."       996 F.
Supp. 2d 335, 350 (E.D. Pa. 2014). Although the complaint in this
case includes allegations that Sarepta limited the size of its
Phase IIb trials because it could not afford larger trials, the
complaint lacks allegations that the company's financial condition
at the time of the alleged misrepresentations was the same as, or
worse than, the company's financial condition when it undertook
the Phase IIb trials.

                                        - 23 -
But the complaint does not allege that the defendants predicted or

intended this result ex ante.           After all, "considerable public

attention" also means closer scrutiny.              And given that outside

pressure on the FDA plays no clear or generally acknowledged role

in the agency's closely regulated process, as the complaint's

allegations themselves reflect, it seems a stretch to infer that

the defendants risked closer scrutiny simply to apply indirect

pressure on a regulator's data-driven decisionmaking process.

          When   we    consider       the   totality   of     the   complaint's

allegations,   and    measure   the    malicious     inference      against    the

innocent ones, we do not find "the malicious inference [to be] at

least as compelling as any opposing innocent inference."                  Zucco

Partners, LLC v. Digimarc Corp., 552 F.3d 981, 991 (9th Cir. 2009)

(citing   Tellabs,     Inc.,    551     U.S.   at    323)).         Sarepta,     a

biopharmaceutical company navigating the uncertain terrain of

accelerated approval for a gene therapy, was energized by clinical

trial data, which it shared with the FDA.            In the ensuing dialogue

between the company and the agency, the initially unwelcoming

agency cracked open the door to a possible approval by stating a

willingness to consider a new drug application for the therapy

while cautioning the company about the importance of more and

better data for accelerated approval.               The company shared this

obviously good news about the FDA's new receptiveness to possible

acceptance of a filing while conveying enough caveats so that the

                                  - 24 -
stock price actually dropped.                As the company moved toward filing

for regulatory approval, a competitor drug candidate with the same

mechanism posted disappointing results, and the FDA decided that

a    new      drug    application      for    the       company's    therapy      would       be

premature, causing a more substantial drop in stock price.                                   The

only plausible motive for fraud identified by the plaintiffs is

revenue        generation,     which       falls     short     of    pleading     a    cogent

inference of scienter that can carry the day here.                        More plausible

is the opposing innocent inference that the defendants, perhaps

negligently, waxed too optimistically about the FDA's expression

of    a       willingness    to     consider       an    NDA   for    eteplirsen        while

emphasizing          too   little    the     FDA's      reservations      about       such    an

application.          This is simply a case in which the complaint focuses

too much on nuance rather than false facts or material omissions

to   support         the   necessary    strong       inference       of   scienter.           We

therefore affirm dismissal of the section 10(b) and Rule 10b–5

claims as well as the derivative section 20(a) claims.5

          5
      The plaintiffs have filed two separate appeals from rulings
of the district court. The first appeal challenges a ruling that
amendment would be futile due to insufficient allegations in the
proposed second amended complaint of falsity and materiality. We
need not address the sufficiency of allegations as to those
elements.   The second amended complaint contained even fewer
allegations of scienter than its successors, and so our decision
today that the most recent and most complete version of the
complaint lacks sufficient allegations of scienter resolves both
appeals.

                                           - 25 -
                                     III.

             Notwithstanding   five    tries   to    get   it   right,   the

plaintiffs     have   failed   to    satisfy   the    requisite    pleading

standards.      We reject the plaintiffs' appeals and affirm the

district court's dismissal of this action.

                                    - 26 -