FDA Investigation Unlikely to Influence Biogen's (BIIB) Aduhelm Uptake - Analyst

On Friday, July 9th, 2021, acting FDA Commissioner, Dr. Janet Woodcock, published an open letter pushing for a Federal investigation into the approval process of Biogen's (NASDAQ: BIIB) Alzheimer’s drug Aduhelm – the latest in a series of probe requests by advocacy groups and government officials.

The announcement sent shares nearly 3% lower, as investors feared what such an investigation might uncover.

Despite the market reaction, Truist Securities analyst Robyn Karnauskas believes initial indications point that “this is just a check-the-box decision.”

She goes on to note: “Key points in Dr. Woodcock's letter, in our opinion, include: 1) there has been controversy surrounding the approval; 2) focus on interactions between BIIB and FDA staff during process; 3) she noted tremendous confidence in integrity of CDER staff; and 4) critical to review events that occurred during review process by an independent body to ensure public confidence in the FDA.” Based on that, the analyst believes “no matter what the outcome of the investigation, we think it is unlikely to influence the uptake of the drug.”

Truist Securities maintains a “Buy” rating with a $647 price target on BIIB.

Written by Vlad Schepkov | [email protected]

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