For Biogen, the Food and Drug Administration’s expected decision Monday on its Alzheimer’s drug is what a JPMorgan Chase & Co. analyst called "the mother of all binary events" -- one that could send its shares veering sharply in either direction.
If regulators give the company approval to market the drug, called aducanumab, the stock could surge to as much to USD 450, according to Wall Street analysts. Or it could tumble to USD 200 if the treatment is shot down, according to Cory Kasimov, the JPMorgan analyst who follows the company.
Get full access for you and your coworkers.
Start a free company trial todayAlready a member? Log in.
More from MedWatch
More disappointment for Orphazyme as FDA rejects Niemann Pick C application
The FDA have rejected an application for marketing authorization for Orphazyme's main drug candidate, arimoclomol, as a treatment for metabolic disease Niemann Pick C. The authority wants more data.
Orphazyme CEO silent on potential firings in wake of FDA rejection
The FDA rejection of Orphazyme's drug candidate in its main indication will trigger major cuts at the biotech firm, but CEO Christophe Bourdon has no comment on where they will be implemented and how hard the US organization will be hit.
Orphazyme cuts guidance following FDA setback
Friday's disappointing rejection letter from the US FDA is affecting Orphazyme's guidance for 2021. Now, the biotech firm forecasts an operating deficit of DKK 670-700m, up from DKK 100-150m.
Top Orphazyme figure on FDA rejection: "It is very disappointing and very unexpected"
Biotech heavyweight Bo Jesper Hansen is very disappointed over the FDA rejection of Orphazyme's only drug candidate.
US OTC hearing aid channel back on Department of Health agenda
The US health department aims to have a hearing on publishing the regulatory framework for selling hearing aids over the course of the year.
Associate Director, Biostatistics - Genmab 
Analytical Coordinator (Senior scientist) – Permanent position, Symphogen 
Clinical Supply Manager/Specialist - Lundbeck 
Chief Physician - Clinical Innovation Centre, Novo Nordisk 
Global Medical Affairs Lead - Y-mAbs Therapeutics 
Regulatory affairs life cycle specialist 
Chemist responsible for validation and qualification for Laboratory Automation Development 
Clinical Supply Coordinator - Klifo 
(Senior) Regulatory Science Specialist - IWA Consulting 
Employee for regulatory department