Biogen (BIIB) has kicked off first quarter biotech earnings with a top- and bottom-line beat. However, the company surprised investors by announcing a significant delay to the aducanumab BLA (biologics license application) filing, which is now set for 3Q instead of early 2020. Aducanumab is a human monoclonal antibody designed to treat early Alzheimer’s disease.“Among the new disclosures are a pre-BLA meeting this summer and additional “formal interactions” with the FDA (such as Type C meetings); these were not previously communicated and may raise questions on how receptive FDA is to this BLA” comments JP Morgan analyst Cory Kasimov.As a …read more
Source:: Yahoo Finance
