Biogen Inc

Quantli Newsdesk

· a month ago

The FDA has approved a supplemental Biologics License Application for LEQEMBI IQLIK (lecanemab-irmb), enabling once-weekly subcutaneous treatment initiation for early Alzheimer's disease. The approval is supported by clinical data showing exposure and safety profiles comparable to intravenous administration, with a U.S. launch planned for late August 2026.

Quantli Newsdesk

· 3 months ago

Biogen announced plans to advance diranersen, an experimental Alzheimer's drug targeting tau protein, to Phase 3 trials based on signals of tau reduction and cognitive benefit at the lowest dose. However, the mid-stage trial showed unclear dose-response patterns, with higher doses failing to outperform lower ones, leaving some analysts cautious.

10-K

Quantli Newsdesk

· 4 months ago

Biogen reported 2.2% revenue growth to $9.9 billion driven by new product launches (SKYCLARYS, QALSODY, ZURZUVAE), but faces declining MS franchise (-7.1%) due to generic and biosimilar competition. Operating margin compressed as expense growth (+7.3%) outpaced revenue growth, resulting in a 21.4% decline in diluted EPS.