Biogen Is Seeking US approval to Resurrect Alzheimer’s drug

All is not what it seems in the science of pharma. According to Biogen, the data from more patients in two discontinued studies showed that the drug improved cognition at high doses.

Biogen is planning to file for U.S. regulatory approval for its Alzheimer’s treatment aducanumab.

I really don't understand decisions like these, when previous data pointed to the failure of the drug. But that's why they are calling it a resurrection. You see, Biogen and partner Eisai had in March decided to end two late-stage trials of the treatment based on a so-called “futility analysis” of data, which revealed the trials had little hope of succeeding.

According to Bloomberg, this move by Biogen -- if successful -- would be the drug industry’s most dramatic reversal of fortune in history. It has Biogen's stock surging up to 30% in pre-hours trading, and it should be an interesting stock to watch today.

According to CNBC, Alzheimer’s makes up 60-70% of an estimated 50 million cases of dementia globally. If this passes, it would garner billions in sales, since there are no currently approved therapies for reversing the decline of Alzheimer’s and any successful new treatment would be like a first-mover essentially.

Biogen now says patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language. That is incredible news if it's validated by more studies.

Drugs for severe dementia brought back from the dead? That's exactly what this appears to be. The filing with U.S. regulators could “potentially bring back to life a drug that had been completely left for dead,” RBC Capital Markets analyst Brian Abrahams wrote in a note. But will it be able to truly help patients?

The results of the drug have been mixed, so it's quite a shocker. Biogen's total revenue rose nearly 5% to $3.60 billion in Q3.

Biogen is under pressure to acquire and grow in an ultra competitive market. With AI poised to impact exponential tech in the biogenetic industry, healthcare and the future of pharma, we are just at the tail beginning of a golden age of biotech global firms.

Amid many contenders Biogen would be well positioned if this goes through. Can you imagine the impact on Alzheimer patients if this really helps?

Edit: At 10:50am the stock is up 26.64% or $60 on the news. Some analysts believe it could literally be the "biggest drug ever". However, it's a stark reversal as this (reuters) announcement comes just months after Biogen discontinued clinical studies for the same drug following a data analysis that did not achieve its objective.