Biogen Shares high up after great News

Biogen Inc. (Nasdaq: BIIB) saw its shares surge, valued at over $ 15 billion, after the FDA appeared to endorse its controversial Alzheimer's drug.

Aducanumab will be the first drug to receive approval for slowing the progression of memory loss, not just treating symptoms, making it a guaranteed blockbuster. The promise comes with some controversy, however, as the company stopped two identical studies in 2019 and labeled them as failures, but later revived one study after re-analysis as a success. Against this background, the FAD published a positive review of aducanumab on Wednesday.

That news sent Biogen stock up more than 40%, adding to the company's valuation of over $ 15 billion. Although one has to be optimistic about treating Alzheimer's disease, getting the drug approved will be a mistake. This will significantly lower the standards of the FDA if the regulator were to do the opposite. The company had many excuses for the mixed results in the two studies, even if they were similar. For example, Biogen suggests that the failed study was disproportionately influenced by a small group of subjects with rapidly progressing Alzheimer's disease. Although it suffered a setback, after collecting and analyzing additional data, the company found the study supportive.

It appears that the FDA is okay with the unprecedented resuscitation and would likely approve aducanumab as the first drug to slow the progression of AD. However, opinions are divided among researchers as to whether aducanumab works as the company claims.

In its briefing for the panel on Friday, the FDA described one of the studies as "robust and exceptionally compelling" while downplaying the failed, contradicting study. Usually the FDA has been known for getting into the details of all the facts rather than helping along the way. Unfortunately, the skeptical sections of the FDA's statistical analysis highlighting biases and inconsistencies in the data have been masked under a positive message.