A lawsuit was filed on behalf of investors in Biogen Inc. (NASDAQ:BIIB) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 02/23/2022 -- An investor, who purchased NASDAQ: BIIB shares, filed a lawsuit against Biogen Inc over alleged Securities Laws violations.
Investors who purchased shares of Biogen Inc. (NASDAQ: BIIB) have certain options and for certain investors are short and strict deadlines running. Deadline: April 8, 2022. NASDAQ: BIIB investors should contact the Shareholders Foundation at firstname.lastname@example.org or call +1(858) 779 - 1554.
In March 2019, Biogen Inc. announced it was abandoning Aduhelm, its potential drug for treating Alzheimer's disease.
Then six months after announcing it was abandoning Aduhelm as futile and that the drug failed to show any clinical benefit, Biogen Inc. announced it was submitting the drug for FDA approval, portraying the same supporting data as demonstrating the drug as safe and effective.
Aduhelm was approved through the FDA's Accelerated Approval process for the treatment of Alzheimer's on June 7, 2021.
Shares of Biogen Inc. rose to over $100 per share on June 7, 2021.
However, the plaintiff alleges that over the next six months, investors learned that Aduhelm would not be the blockbuster drug to conquer Alzheimer's or replace Biogen's MS drug line-up because the drug was dangerous and ineffective, hospital networks refused to prescribe it, and major insurance companies refused to pay for it.
Members of the FDA advisory panel resigned in protest over Aduhelm's approval and Congress demanded to know how the drug had been approved.
By October 2021, Aduhelm was not selling well and in December other global regulators had denied its approval.
On January 11, 2022, post-market, the Center for Medicare and Medicaid Services ("CMMS") announced its draft decision on reimbursement for Aduhelm, Biogen's proposed treatment for Alzheimer's disease. CMMS proposed to cover reimbursement under "Coverage with Evidence Development," limiting reimbursement only to patients enrolled in a clinical trial. Additionally, it limited those patients eligible as those with mild forms of cognitive impairment or mild dementia and those patients who already have amyloid plaques. Further, CMMS proposed limiting reimbursement to clinical trials in a hospital-based outpatient setting. CMMS's reimbursement decision functionally amounted to agreeing to reimburse Biogen for running a new clinical trial, all but destroying the value of Aduhelm as an approved drug.
Shares of Biogen Inc. (NASDAQ: BIIB) declined to as low as $212.56 per share on February 3, 2022.
The plaintiff claims that between June 7, 2021 and January 11, 2022, the Defendants made materially false and/or misleading statements and/or failed to disclose that there was a significant, undisclosed lobbying campaign between Biogen and the Food and Drug Administration ("FDA") that was instrumental in the decision to file and approve Aduhelm, a drug being developed to treat Alzheimer's disease, that the Phase III ENGAGE study demonstrated that Aduhelm failed to achieve a clinical benefit to Alzheimer's patients, that ENGAGE was a failed study from which Biogen concluded not to seek FDA approval for Aduhelm in 2019, and that defendants misled investors as to the way in which approval was achieved, that the clinical data did not support a clinical benefit by taking Aduhelm and that side-effects were dangerous and serious.
Those who purchased shares of Biogen Inc. (NASDAQ: BIIB) have certain options and should contact the Shareholders Foundation.
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