Shares of Biogen fell Wednesday morning following the company’s announcement that it would push back its regulatory filing for a long-awaited drug to treat Alzheimer’s disease until the summer.
The Cambridge, Massachusetts-based biotech company announced its first quarter 2020 earnings, with the total revenues of $3.5 billion reflecting a 1% increase over the first quarter of last year. The increase reflected increased sales of its multiple sclerosis drugs, the spinal muscular atrophy drug Spinraza (nusinersen) and biosimilars, offset by a decrease in other revenues due to the spin off of its hemophilia business.
Nevertheless, the company said that it would complete the open Food and Drug Administration filing for its Alzheimer’s drug, aducanumab, in the third quarter, despite a previous expectation that it would complete the filing in the first half of this year. It said it had been in formal interactions with the FDA and was preparing for a pre-biologics license application meeting with the agency expected to take place in the summer, after which it would complete the filing.
Shares of Biogen were down more than 7% on the Nasdaq in premarket trading and were down by more than 8% shortly after markets opened.
In a note to investors, RBC Capital Markets analyst Brian Abrahams wrote that the aducanumab application timeline being pushed back “underscores the complexity” of the clinical trial data being submitted and its interpretation. That means the FDA would likely complete the review well after the presidential election, thereby lowering the possibility of there being a political motivation for the drug’s approval on mixed data, he wrote.
Biogen originally stopped its Phase III development program for aducanumab, a monoclonal antibody that targets the protein amyloid beta, after determining from early data that the two studies were not likely to be successful. The decision was seen as a major blow not just to the company and its product candidate, but to the entire hypothesis that targeting amyloid beta can address Alzheimer’s disease. The company subsequently revived the drug after an analysis of data from one of the studies seemed to indicate a benefit, though it has remained controversial, particularly among investment bank analysts.
Photo: John Tlumacki, The Boston Globe, via Getty Images