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Biogen Aduhelm Class Action Lawsuit Overview:
- Who: Biogen investors have filed a securities fraud class action lawsuit alleging the company misled them about the efficacy of its Alzheimer’s drug Aduhelm.
- Why: Shares of Biogen stock soared after the company announced it would seek U.S. Food and Drug Administration approval of the drug, which they had nearly abandoned.
- Where: The lawsuit was filed in Massachusetts federal court.
Biogen is facing a securities fraud class action lawsuit filed by investors who allege Biogen announced that it would apply for U.S. Food and Drug Administration (FDA) approval of its Alzheimer’s drug Aduhelm (aducanumabab) despite nearly abandoning the medication.
The Aduhelm class action lawsuit alleges Biogen participated in closed-door meetings with the FDA and subsequently decided to apply for FDA approval based on a new interpretation of data from an older clinical trial.
Once Biogen announced that it would seek FDA approval for Aduhelm, shares of Biogen stock soared to more than $100 per share.
The FDA approved Aduhelm in June 2021, the first time the agency had granted approval to an Alzheimer’s drug since 2003,according to the lawsuit. Various experts cautioned against the use of Aduhelm due to its limited effectiveness and potential health risks, which may include bleeding and swelling in the brain.
FDA advisory panel members resigned in protest over Aduhelm’s approval, according to the Biogen class action lawsuit. Further, hospitals refused to prescribe the drug and insurance companies allegedly refused to pay for Aduhelm, the investors allege.
Congress has launched a probe into Adulelm’s approval process, and Medicare reportedly released a draft of a coverage proposal that would allow only clinical trial participants to be prescribed the Alzheimer’s medication.
In response to this information, Biogen’s stock price dropped to $225 per share, a decrease of more than 40% of the price that the Biogen shares traded just after the FDA approval announcement.
The Biogen class action lawsuit was filed on behalf of investors who purchased Biogen shares between June 7, 2021, and Jan. 11, 2022.
Aduhelm Clinical Trials Show Mixed Results
Aduhelm reportedly works by removing amyloid beta. Although one phase 3 trial was stopped due to lack of efficacy, another trial involving a higher dose allegedly showed reduced decline in cognition, language, memory and activities of daily living.
The drug is administered with monthly infusions. Because of the risks of bleeding and swelling in the brain, safe treatment protocol may require patients to undergo regular brain scans.
In November 2020, a panel of FDA advisors voted against approving Aduhelm, and some critics argued that there was insufficient evidence to support the drug’s approval without more clinical trials, the class action lawsuit states.
Other Drugmakers Under Fire for Misrepresenting Alzheimer’s Meds
Shareholders have also alleged biotech company Cassava Sciences Inc. manipulated data about its Alzheimer’s medication simufilam, falsely inflating stock prices. A citizen petition submitted to the FDA asked the agency to stop clinical trials of the drug due to “a series of anomalies that are suggestive of systematic data manipulation and misrepresentation.” News of the citizen petition caused Cassava’s shares to drop at least 32%.
Annovis Bio Inc. is also facing a securities fraud class action lawsuit filed by investors who allege the company made inflated claims about the success of its Alzheimer’s drug trial. After it was revealed that the clinical drug trial participants were not showing clinical improvement, Annovis’s share price dropped 60%.
Did you invest in Biogen after you learned the FDA approved the Alzheimer’s drug? Tell us about your experience in the comments below.
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7 thoughts onAduhelm Class Action Alleges Biogen Misled Investors About Alzheimer’s Med
It was only known with certainty that the drug gave Brain Hemorraiges and was sold as it was normal to be diseased by a drug… So nowadays severe sid effects are normal…
I have worked with someone of the top of biogen and I can only say: they are a bunch of liars.
The pretend they are absolutely good people with highest integrity values. At the end, they do the contrary as they say and do “Science by friendship”. They interweave Scientists, political medical doctors in several associations that know each other and cover each other up. In this case, the meeting of the records of high chiefs of biogen with FDA is a clear attempt of fraud and bribery… For a product that was not expected to have clear results… and presumably they knew it. Otherwise you go for the normal path. Blue Cross Blue Shield accepted Aduhelm because one of their Chiefs has relationship with one chief of Biogen… Claims that they do it for patients while putting the highest price for Medicare defines an hypocrite group of individuals …
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I believe Annovis is not subject any pending class actions lawsuits. I understand the suits were voluntarily dismissed. Apparently the claims were without merit. You may want to check your facts.
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