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https://www.barrons.com/articles/stock-market-movers-9cc9fac3
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The U.S. Food and Drug Administration on Thursday granted full approval to the Biogen BIIB and Eisai Co. Ltd. ESALF Alzheimer’s treatment Leqembi, a step that secures Medicare reimbursement for the first drug shown to slow the progress of the disease, rather than just treating its symptoms.
Leqembi, also known as lecanemab, is a monoclonal antibody designed to reduce the buildup of amyloid beta plaque in the brain, a marker of Alzheimer’s disease.
The…
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The U.S. Food and Drug Administration said Tuesday it has granted accelerated approval to Biogen Inc.’s torferson, a treatment for a rare form of amyotrophic lateral sclerosis, or ALS.
The accelerated program is used to approve drugs for serious conditions that have an unmet medical need, where a drug is shown to have an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients.
In…
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Biogen’s Alzheimer’s Drug Could be Expensive
Biogen (NASDAQ: BIIB) could price its Alzheimer’s drug, Lecanemab, developed along with Essai as high as $20,000 every year, Barron’s reported on Friday, citing data from The Institute for Clinical and Economic Review. The…
on TipRanks.com
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Biogen’s Alzheimer’s Drug Could be Expensive
Biogen (NASDAQ: BIIB) could price its Alzheimer’s drug, Lecanemab, developed along with Essai as high as $20,000 every year, Barron’s reported on Friday, citing data from The Institute for Clinical and Economic Review. The…
on TipRanks.com
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Biogen Inc. shares
BIIB,
rose 4.7% in premarket trade Monday, after MorphoSys and partner Roche said a trial of a treatment for Alzheimer’s disease failed to meet its main goal. German-listed shares of MorphoSys
MOR,
MOR,
fell 30% on the news, while Roche
ROG,
was down 4% in Zurich as the company said Phase 3 studies evaluating gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer’s and mild Alzheimer’s dementia did not meet their primary endpoint of slowing clinical decline. Biogen, which last week named former Sanofi CEO Christopher Viehbacher as its new CEO, has a follow-up to its Alzheimer’s treatment aduhelm in trials. Dubbed lecanemab, the drug slowed cognitive decline by 27% in a Phase 3 clinical trial, according to data released by Biogen and partner Eisai in October. The drug also appears to help people with day-to-day functions, like managing their finances, taking care of household responsibilities, and being able to leave their homes, executives said Tuesday during an earnings call. Additional data is expected by the end of November and Biogen has said it would submit the drug for full approval by March of 2023. Biogen shares are up 21% in the year to date, while the S&P 500
SPX,
has fallen 16%.
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