Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 1612 13 important cases to watch in 2017 goodwin were at an elevated risk of developing low lympho- cyte counts while taking Tecfidera. Plaintiffs allege that between April and June of 2014, Biogen was aware that the Center was reducing its Tecfidera prescriptions, and in August 2014, the medical director of the Center noti- fied Biogen that Tecfidera was causing low lymphocyte counts among approximately 30% of its MS patients taking the drug. At that time, the Center stopped pre- scribing Tecfidera altogether, and made Biogen aware of its decision to do so. Plaintiffs allege that Biogen failed to disclose these developments and continued to highlight Tecfidera’s safety and growing sales. The remainder of plaintiffs’ allegations mirror those in Bio- gen I (discussed on p. 6). On December 23, 2016, three investors moved to be appointed lead plaintiff and to approve their selection of lead counsel. One of these investors also moved to stay the proceedings pending resolution of the appeal of Biogen I pending before the First Circuit. On February 1, 2017, the court approved lead plaintiff and lead counsel and denied the motion to stay. Mazurek v. Seres Therapeutics, Inc. et al., Case No. 1:16cv11943 (D. Mass.) (Judge Denise J. Casper) Seres Therapeutics is a clinical-stage biopharmaceuti- cal company focused on developing medicines to treat diseases resulting from functional deficiencies in the microbiome. The company’s lead product candidate is SER-109, a clinical-stage oral microbiome therapeutic designed to prevent further recurrences of Clostrid- ium difficile infection (“CDI”), a debilitating infection of the colon. If approved by the FDA, SER-109 would be, according to the company, “a first-in-field drug.” On September 8, 2014, Seres announced positive data from its Phase 1b/2 clinical trial of SER-109, noting that the drug achieved a 97% cure rate. The SER-109 administered in the 1b/2 trial, however, required up to 15 doses per day, which prompted the FDA to raise concerns about the commercial viability of the drug’s dosage schedule. In response to the FDA’s feedback, Seres produced a new formulation of the SER-109 cap- sule that required four doses per day. Due to this new formulation, the FDA required Seres to conduct a Phase 2 clinical trial instead of moving to a Phase 3 trial, as the company had intended. On July 29, 2016, Seres issued a press release announcing interim 8-week results from the Phase 2 clinical trial of SER-109. The company disclosed that SER-109 had failed to reach its primary endpoint of reducing the relative risk of CDI recurrence when compared to a placebo. On this news, the price of Seres common stock dropped by more than 70%. On September 28, 2016, investors filed a federal securi- ties class action against Seres and two of its executives alleging violations of Sections 10(b), 20(a), and Rule 10b-5 of the 1934 Act. On February 13, 2017, following the appointment of lead plaintiff and counsel, plaintiffs amended their complaint, alleging that Seres and the individual defendants made misleading statements to the public regarding the probability of success of SER-109’s Phase 2 clinical trial, while having access to clinical data from the open-label extension arm of the study indicating a higher rate of failure than expected. Plaintiffs further allege that defendants made mislead- ing statements regarding the reformulated drug used in the Phase 2 trial that caused investors to believe it was the same drug (or a more potent version thereof) that cured 97% of patients with CDI in Phase 1b/2 trial. Plain- tiffs also allege that the individual defendants entered into trading plans shortly after learning of the open-la- bel study’s disappointing results in order to cash in on Seres stock before the markets learned of the results. Defendants’ deadline to move to dismiss the complaint is March 30, 2017. Deborah Birnbach, Partner | +1 617 570 1339 Deborah Birnbach concentrates in the areas of securities litigation, including class action defense; SEC, regulatory and internal investigations; M&A-related litigation; stockholder disputes; fiduciary duty claims; proxy contests; founder and partnership disputes; and private equity litigation surrounding private financings. Her securities and shareholder litigation practice is national in scope and involves representing life sciences, medical device, health care and health care information technology (HCIT) clients. Caroline Bullerjahn, Partner | +1 617 570 1359 Caroline Bullerjahn focuses her securities litigation practice on class action and derivative litigation defense; SEC, regulatory and internal investigations; fiduciary duty and corporate governance matters; and M&A-related litigation. She primarily represents public technology, life sciences and health care companies, and their directors and officers. Katherine Mojena Katherine Mojena is an associate in the firm’s Securities Litigation and White Collar Defense business unit, with a concentration in securities litigation, M&A-related litigation, and complex business litigation matters. Ms. Mojena has represented a wide variety of clients, including public corporations, life sciences companies, private equity firms, and financial services providers. Ben Reilly Ben Reilly is an associate in the firm’s Litigation Department. His practice focuses on SEC, regulatory and internal investigations; securities litigation; commercial litigation; and white collar criminal defense. Meet the Goodwin Securities + Shareholder Litigation team. Authors The Biogen II plaintiffs acknowledged the similarity of their complaint to In re Biogen Securities Litigation(“Biogen I”) complaint, but contended that their complaint includes allegations and facts beyond those raised in Biogen I, as well as a different class period that includes a partial corrective disclosure by defendants.