Alvotech drops after US FDA declines to approve arthritis drug

Shares of biotech firm Alvotech ALVO.O fall 28.8% to $5.45

Late on Sunday, company said the U.S. FDA issued complete response letter declining approval for Alvotech's drug, AVT05, a biosimilar to Johnson & Johnson's JNJ.N Simponi for treatment of patients with rheumatoid arthritis

FDA cites unresolved deficiencies from July 2025 inspection of Alvotech's Reykjavik, Iceland facility

Company notes the facility remains FDA approved to manufacture and continues supplying currently commercialized products

The FDA did not identify any other deficiencies with the application - ALVO

Following the receipt of the CRL, Alvotech lowers its 2025 total revenues to a range of $570 million to $600 million, compared to a prior $600 million to $700 million

Including session's moves, stock down 58.6% YTD