Shash v. Biogen Inc.

CourtDistrict Court, D. Massachusetts
DecidedMarch 27, 2025
Docket1:21-cv-10479
StatusUnknown

This text of Shash v. Biogen Inc. (Shash v. Biogen Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Shash v. Biogen Inc., (D. Mass. 2025).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

NADIA SHASH and AMJAD KHAN, * individually and on behalf of all others * similarly situated, * * Plaintiffs, * * v. * Civil Action No. 1:21-cv-10479-IT * BIOGEN INC., MICHEL VOUNATSOS, * ALFRED W. SANDROCK, JR., and * SAMANTHA BUDD-HAEBERLEIN, * * Defendants. *

MEMORANDUM & ORDER

March 27, 2025 TALWANI, D.J. This securities fraud class action is before the court on remand from the First Circuit. In September 2022, the court granted the Motion to Dismiss filed by Defendants Biogen, Inc., and three of its executives (collectively, “Biogen”). See Mem. & Order [Doc. No. 76]. On appeal, the First Circuit affirmed the dismissal except as to one allegedly misleading statement and remanded the case for further proceedings as to that statement. Now pending are Biogen’s Motion for Judgment on the Pleadings [Doc. No. 116] and Plaintiffs Nadia Shash and Amjad Khan’s Motion for Leave to Add Additional Plaintiffs [Doc. No. 138]. For the reasons that follow, Biogen’s motion is DENIED, except as unopposed as to the dismissal of claims against Defendant Samantha Budd-Haeberlein; and Plaintiffs’ motion is GRANTED as to two of the proposed additional plaintiffs and DENIED as to one. I. Factual Background A fulsome recounting of the facts alleged in Plaintiffs’ Second Amended Complaint [Doc. No. 58] can be found in Shash v. Biogen, Inc., 84 F.4th 1, 6-10 (1st Cir. 2023). The facts alleged as relevant to the remaining statement at issue are as follows: A. Clinical Trials

Biogen developed aducanumab, a drug intended to treat Alzheimer’s disease by targeting aggregated amyloid beta. Second Am. Compl. ¶¶ 57-58, 61 [Doc. No. 58]. To study the effects of aducanumab on Alzheimer’s patients and generate the data necessary to seek full approval of the drug, Biogen submitted an investigational new drug application to the Food and Drug Administration (“FDA”) in 2011. Id. ¶ 66. Relevant here are the results of aducanumab’s Phase III trials, named ENGAGE and EMERGE. Id. ¶¶ 77, 81, 149-50. In March 2019, Biogen announced the termination of both studies on futility grounds. Id. ¶ 108. However, when Biogen conducted its own internal review of the data, disaggregating it to analyze ENGAGE and EMERGE independently (as opposed to pooling data from both studies as required for the futility analysis), Biogen found “that in EMERGE, the high dose reduced clinical

decline . . . .” Id. ¶¶ 101, 118, 181. Biogen brought these findings to the FDA and, on October 22, 2019,1 announced that it would seek FDA approval of aducanumab because the data showed “that sufficient exposure to high dose aducanumab reduced clinical decline across multiple clinical endpoints.” Id. ¶ 171.

1 The class period in this action runs between October 22, 2019, and November 6, 2020, inclusive. Id. ¶ 1. B. The “All Data” Statement Biogen reported its findings on aducanumab on multiple occasions, but the only relevant statement for present purposes is what the First Circuit and this court refer to as the “‘all data’ statement.” See Shash, 84 F.4th at 12. The “all data” statement was made by Defendant Alfred

Sandrock, Jr., at a quarterly earnings call on July 22, 2020, in which he said: “So consistent with the findings from ENGAGE and EMERGE, you really need to get the higher dose. And I think our data are all consistent with that.” Second Am. Compl. ¶ 191 (emphasis added) [Doc. No. 58]. C. The Briefing Materials and Massie Report The FDA empaneled an advisory committee (the “Advisory Committee”) to assist in its review of Biogen’s application for full FDA approval of aducanumab. Id. ¶¶ 259-61. “The primary role of an advisory committee is to provide independent advice that will contribute to the quality of the agency’s regulatory decision-making and lend credibility to the product review process.” Id. ¶ 259. Given the controversial nature of the clinical trials and uncertainty around the results, stock analysts recognized the Advisory Committee’s decision would be a critical

factor in determining the fate of aducanumab. Id. ¶¶ 260-61. In advance of the Advisory Committee meeting scheduled for November 6, 2020, Biogen and the FDA jointly prepared briefing materials (the “Briefing Materials”), which the FDA published on its website during the trading day on November 4, 2020. Id. ¶¶ 262-63, 280. In the Briefing Materials, the FDA provided an “effusive” endorsement of Biogen’s post hoc analysis, methodology, and conclusions. Id. ¶ 264. The Briefing Materials set out Biogen’s position and the FDA’s responses, the majority of which expressed agreement with Biogen’s position. Id. ¶ 265. Appendix 2 to the Briefing Materials contained a dissenting report prepared by the FDA’s statistical reviewer on aducanumab’s application, Tristan Massie (the “Massie Report”). Id. ¶¶ 16, 273; see also id., Ex. 3 [Doc. No. 58-3]. The Massie Report bore a “DRAFT” watermark on its pages. See generally id., Ex 3. The Massie Report challenged the Briefing

Material’s support for approval, concluding in its Executive Summary that “the totality of the data does not seem to support the efficacy of the high dose” and that “there is no compelling substantial evidence of treatment effect or disease slowing.” Id., Ex. 3 at 9-10. D. Plaintiffs’ Stock Purchases On November 4, 2020, the same day the Briefing Materials and Massie Report were published, Biogen’s stock price increased from $253.20 per share at opening to $355.63. Second Am. Compl. ¶¶ 276-78 [Doc. No. 58]. “[I]t [was] plain that even analysts whose job was to cover Biogen had not read the Draft Massie Report but had noticed the FDA’s clear bias in favor of approval[.]” Id. ¶ 276. Lead Plaintiff Shash purchased her shares the same day. Decl. of Laurence M. Rosen ISO Mot. for Appointment as Lead Pl., Ex. 2 at 2 (Shash Certification) [Doc.

No. 10-2]. On November 5, 2020, “after investors had begun to digest the Massie Report’s findings, Biogen’s stock price had fallen” to $328.90 per share. Second Am. Compl. ¶ 279 [Doc. No. 58]. Plaintiff Khan purchased shares the same day. Am. Compl., Ex. 2 at 1 (Khan Certification) [Doc. No. 42-2]. On Friday, November 6, 2020, trading in Biogen’s shares was halted pending the Advisory Committee’s meeting to discuss aducanumab, and trading did not resume until Monday, November 9, 2020. Second Am. Compl. ¶ 280 [Doc. No. 58]. After a full day of review, the Advisory Committee voted on several questions related to aducanumab; as relevant here, it voted almost unanimously that the post-hoc analyses of data from EMERGE could not reasonably be considered as “primary evidence of effectiveness of aducanumab for the treatment of Alzheimer’s disease.” Id. ¶ 281. “The cause of the panel’s dissatisfaction was the facts revealed in the Draft Massie Report.” Id. ¶ 282.

On November 9, 2020, when trading resumed, Biogen’s stock closed at $236.26 per share. Id. ¶ 294. II. Procedural Background A. This Court’s Order of Dismissal On September 12, 2022, the court granted Biogen’s Motion to Dismiss. See Mem. & Order [Doc. No. 76]. The court found that Plaintiffs failed to state a claim that Biogen misled investors about the efficacy of aducanumab because: Plaintiffs did not sufficiently allege that Biogen’s statements were misrepresentations, id. at 19-33; Plaintiffs did not sufficiently plead scienter, id. at 34-38; and Plaintiffs failed to plead loss causation because the Massie Report was published prior to Plaintiffs’ purchase of Biogen stock, and “causation is not tied to when the market reacts to information, but rather when that information became available to the public.”

Id. at 40. The court did not reach the question of reliance. See id. at 41. B.

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