SOME Biogen chatterBiogen investors expect company to win approval for Alzheimer’s drug: RBC survey May 25, 2021 1:05 PM ET
Biogen Inc. (BIIB)By: Dulan Lokuwithana, SA News Editor
10 Comments - A majority of Biogen (BIIB -1.8%) investors predict the company to win the FDA approval for experimental Alzheimer’s disease therapy aducanumab albeit with restrictions, according to a survey conducted by RBC Capital Markets.
- With restrictive monitoring requirements, the FDA approval will narrow its use to a select group of patients, most of the respondents in the survey have indicated.
- Rejection of approval could lead to a 30% drop in Biogen shares, 40% of the respondents have said in the study that involved 47 mainly specialist investors.
- Full approval and conditional approval will add 50% and 20%, respectively, wrote analyst Brian Abrahams citing the survey.
- In January, the FDA extended the review period of the Biologics License Application (BLA) filed by Biogen and Eisai Co. (OTCPK:ESALF) for aducanumab by three months making June 07 the new PDUFA
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https://www.fiercepharma.com/pharma/biogen-s-swiss-based-plant-receives-regulatory-nod-as-agency-readies-launch-for-alzheimer-s
Biogen's $1B Swiss plant scores regulatory nod as drugmaker awaits pivotal FDA decision on aducanumab
by
Noah Higgins-Dunn |
May 25, 2021 11:05am
Despite a flurry of uncertainty surrounding Biogen’s Alzheimer's hopeful aducanumab, the company has forged ahead with its launch preparations ahead of a pending FDA decision. Now, its Swiss manufacturing facility is a step closer to eventually churning out doses—should the drug score an approval.
Switzerland’s medicines surveillance authority, the Swiss Agency for Therapeutic Products (Swissmedic),
issued Biogen's Solothurn manufacturing facility a Good Manufacturing Practice (GMP) license, the company said.