Lawsuit Overview
April 26, 2021 - An amended complaint was filed.
March 17, 2021 - The case was transferred to the U.S. District Court for the District of Massachusetts.
November 13, 2020 - An investor in shares of Biogen Inc. (NASDAQ: BIIB) filed a lawsuit in the U.S. District Court for the Central District of California over alleged violations of Federal Securities Laws by Biogen Inc. in connection with certain allegedly false and misleading statements made between October 22, 2019 and November 6, 2020.
Cambridge, MA based Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. Biogen Inc. reported that its annual Total Revenue rose from over $13.45 billion in 2018 to over $14.37 billion in 2019 and that its EBIT increased from over $6.1 billion in 2018, to over $7.31 billion in 2019.
On November 6, 2020, Biogen Inc announced that the Company's proposed Alzheimer's therapy had failed to win support from the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee. Specifically, Biogen Inc disclosed that the Advisory Committee voted 1 yes, 8 no and 2 uncertain on the question, 'Does Study 302 (EMERGE), viewed independently and without regard for Study 301 (ENGAGE), provide strong evidence that supports the effectiveness of aducanumab for the treatment of Alzheimer's disease?'. The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, 'Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer's disease?', and 5 yes, 0 no and 6 uncertain on the question, 'Has the Applicant presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer's disease pathophysiology?'. Finally, the Advisory Committee voted 0 yes, 10 no and 1 uncertain on the question, 'In light of the understanding provided by the exploratory analyses of Study 301 and Study 302, along with the results of Study 103 and evidence of a pharmacodynamic effect on Alzheimer's disease pathophysiology, it is reasonable to consider Study 302 as primary evidence of the effectiveness of aducanumab for the treatment of Alzheimer's disease?' Shares of (NASDAQ: BIIB) declined from $363.92 per share on November 4, 2020, to $223.25 per share on November 9, 2020.
According to the complaint the plaintiff alleges on behalf of purchasers of Biogen Inc. (NASDAQ: BIIB) common shares between October 22, 2019 and November 6, 2020, that the defendants violated Federal Securities Laws.
More specifically, the plaintiff claims that between October 22, 2019 and November 6, 2020, the defendants made false and/or misleading statements and/or failed to disclose that the larger dataset did not provide necessary data regarding aducanumab’s effectiveness, that the EMERGE study did not and would not provide necessary data regarding aducanumab’s effectiveness, that the PRIME study did not and would not provide necessary data regarding aducanumab’s effectiveness, that the data provided by the Company to the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee did not support finding efficacy of aducanumab, and that as a result, defendants’ statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.