b'for valoctocogene roxaparvovec without additional10b5 of the 1934 Act, alleging that defendants made data. On December 22, the court appointed a leadfalse and/or misleading statements by failing to disclose plaintiff. Lead plaintiffs amended complaint is due bythat: (1) the larger dataset did not provide necessary February 22, 2021, and any motion to dismiss is due bydata concerning aducanumabs effectiveness; (2) the April 22, 2021.two Phase 3 studies would not provide necessary data regarding aducanumabs effectiveness; and (3) the data Biogen provided to FDA did not support finding Menashe v. Biogen Inc. et al., Case No.efficacy of aducanumab. The statutory lead plaintiff 2:20-cv-10399 (JVS) (C.D. Cal.)process is underway, and lead plaintiff motions were Failed Phase 3 Clinical Studiesfiled in mid-January 2021. A similar putative class action complaint was filed by another Biogen investor in the Biogen Inc. (Biogen) is a Cambridge, Massachusetts-District of Massachusetts on January 5, 2021, and the based biotechnology company that discovers, develops,lead plaintiff process is underway in that case as well.and manufactures therapies for neurological and neu-rodegenerative diseases, including aducanumab, anIn re Inogen, Inc. Sec. Litig., Case No. investigational human monoclonal antibody aimedat treating early Alzheimers disease. Biogen col- 2:19-cv-1643 (FMO), 2020 WL 5361579 lab-orated with Eisai Co., Ltd. (Eisai) to develop and(C.D. Cal. Sept. 2, 2020) commercialize aducanumab globally. Deceptive Sales Tactics and On October 22, 2019, Biogen issued a press releaseShort-Seller Reportannouncing its plans to file a BLA in early 2020 seek- Inogen, Inc. (Inogen) is a medical technology com-ing FDA approval of aducanumab, using results from apany based in California that develops, manufactures, Phase 1/1b and two Phase 3 clinical trials conducted byand markets portable oxygen concentrators to give the company. The press release disclosed that it hadlong-term oxygen therapy to patients with chronic discontinued both Phase 3 studies in March 2019 afterrespiratory conditions. On November 7, 2017, Inogen a futility analysis, but stated that Biogens analysis ofannounced that its third quarter of 2017 was a record new data from the Phase 3 studies collectively provid- revenue quarter, due to increased sales in domestic ed a larger Phase 3 dataset, which the company viewedbusiness-to-business and direct-to-consumer chan-as resolving the previously identified futility issues.nels. Inogen stated that it should see strong results The press release further stated that the larger datasetin 2018 as portable oxygen concentrators continue to demonstrated that aducanumab is pharmacologi- be adopted worldwide, and increased its guidance cally and clinically active in reducing brain amyloidfor full-year 2017 revenue and adjusted EBITDA. That and clinical decline in early Alzheimers patients. Onsame day on an investor call, Inogens CEO attributed January 30, 2020, Biogen issued a press release tout- Inogens growth to its delivery of strong sales and solid ing its excitement about the prospects for aducanum- bottom line results. ab in Alzheimers disease and stating that it looked forward to completing its filing as soon as possible. InInogen continued to report strong results in the follow-the months that followed, Biogen made several oth- ing months, increasing its guidance for full-year 2018 er statements reflecting that it expected to file a BLArevenue and adjusted EBITDA after each of the first and that aducanumab was one of the companys coretwo quarters of 2018. However, when Inogen released growth areas. The BLA was submitted in July 2020its third quarter 2018 financial results on November and granted priority review by FDA in August 2020. 6, 2018, it disclosed a slowdown in sales growth and However, on November 6, 2020, Biogen issued areduced its full-year 2018 adjusted EBITDA guidance press release disclosing that an advisory committeefrom $65-69 million to $60-62 million. Inogens stock of FDA had voted against several counts relating tothereafter fell approximately 19%. On February 12, 2019, the effectiveness of aducanumab for the treatment ofInogens stock further declined after a short-seller Alzheimers disease, including a vote of 1 yes, 8 no, andpublished an investigative report challenging the size 2 uncertain on the question whether Biogens secondof Inogens total addressable market (TAM), the basis Phase 3 study provide[d] strong evidence that sup- for its prior TAM claims, and the allegedly nefarious ports the effectiveness of aducanumab for the treat- source of the companys sales growtha dirty ment of Alzheimers disease. On this news, Biogensreseller network, with a felon convicted of deceptive stock price fell 28%. internet marketing practices allegedly secretly con-trol[ing] Inogens top reseller, along with deceptive On November 13, 2020, investors filed a putative classsales practices that included falsely informing elders action complaint against Biogen and three of its officersthat Medicare would not cover the cost of oxygen for violations of Sections 10(b) and 20(a) and Ruleconcentrators. When the company reported its Q4 2018 57'