Biogen (NASDAQ:BIIB) shares have dipped more than 1% premarket on the back of news that the company and Eisai were unable to file the Leqembi subQ Biologics License Application by the March guidance as the FDA is requiring an additional three months of immunogenicity data.
Reacting to the news, analysts at Jefferies explained in a note that Biogen and Eisai cannot file with a rolling submission until they get Fast Track, which they've now filed for but will need another 60 days to complete.
"The news adds more complexity to the subQ—which is for maintenance after IV, not induction (the latter also not planned until additional discussions with FDA). BIIB is almost within the "no Leqembi" valuation around $200," said Jefferies.
Analysts at Wells Fargo said in a note that the setback for the Leqembi subQ filing "is negative for sentiment."
"We do not think delay in Leqembi subQ review was expected although investor did question if subQ varied too much from IV on plaque clearance," said the firm. "This leaves FDA [to] ask for 3 months' additional immunogenicity data as a surprise. Further, anti-drug antibodies have not presented as a problem for subQ route of administration. This leaves us with little concern around delay but may still be perceived negatively."