Biogen Inc. (BIIB) shares plunged 7.62% in after-hours on Tuesday, January 12, 2022, and closed the daily trading at $223.12. However, in the regular trading session, BIIB’s stock gained 2.64%. BIIB shares have fallen 9.68% over the last 12 months, and they have moved down 0.09% in the past week. Over the past three months, the stock has lost 15.19%, while over the past six months, it has declined 31.40%.
Let’s discuss its recent news & developments.
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Another obstacle to BIIB Alzheimer’s drug
On January 11, 2021, U.S. regulators severely limited which patients can access the controversial BIIB Alzheimer’s treatment, Aduhelm.
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The Centers for Medicare and Medicaid Services announced that it would cover the cost of treatment for patients enrolled in clinical studies but the Biogen has to prove to remove that plaque, called amyloid, leads to a benefit on cognition.
A Biogen spokesperson said that this will exclude almost all patients who may benefit and will significantly limit patient access to an FDA-approved treatment, especially for underserved patients.
Aduhelm was approved by the U.S. Food and Drug Administration in June last year via a path called accelerated approval.
BIIB to host an analytical call
Biogen Inc. (BIIB) will host an analyst Q&A call on Thursday, January 13, 2022, at 8:00 a.m. ET. To access the live webcast, please visit the Investors section of Biogen’s website at investors.biogen.com.
Participation in the recent event
Biogen Inc. (BIIB) recently participated at the 40th Annual J.P. Morgan Healthcare Conference. Which was held on Monday, January 10, 2022.
BIIB license to commercialize BIIB115/ION306
On January 04, 2022, Biogen Inc. (BIIB) exercised its option to obtain from Ionis Pharmaceuticals a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB115/ION306.
Both companies have a strategic collaboration to develop novel therapies to treat neurological disorders. BIIB115 is an investigational antisense oligonucleotide (ASO) in development for spinal muscular atrophy (SMA) that may have the potential to help address additional unmet needs of patients as well as to be administered at extended dosing intervals.
Fast track designation for BIIB Lecanemab
On December 23, 2021, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Lecanemab, which is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease.
Lecanemab is under development by Biogen (BIIB) and Eisai Co., Ltd. In September 2021, Eisai initiated a rolling submission to the FDA of a Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and FDA granted Breakthrough Therapy designation in June of 2021.
The recent limitation for Biogen’s Aduhelm was the reason behind its after-hours sinking on Tuesday. We can expect it to continue to decline on Wednesday as well.