What to know about Biogen's big looming lupus study readout

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

This story first appeared in Adam’s Biotech Scorecard, a STAT newsletter. Sign up here to get it delivered to your inbox. And subscribe to STAT+ to get an unabridged version, with exclusive content.

More than two years have passed since Biogen announced results from a Phase 3 study in lupus. The drug was dapirolizumab and the outcome was positive, in case you were wondering. In the first half of December, Biogen will hope for a repeat, and once again, it’s another lupus drug, litifilimab, that is being evaluated in twin Phase 3 studies.

The looming readout from the TOPAZ-1 and TOPAZ-2 studies is an important test of the R&D revamp and growth strategy that Biogen CEO Chris Viehbacher implemented when he joined the company in 2022. It’s also risky.

STAT+ Exclusive Story