Basilea off on Zevtera MAA delay

Basilea (SIX:BSLN) was off CHF40.70 (37%) to CHF70 on Tuesday after it and partner Johnson & Johnson (NYSE:JNJ) said EMEA's CHMP will delay a decision on an MAA for Zevtera ceftobiprole to treat complicated skin and soft tissue infections (cSSTIs) pending Good Clinical Practice (GCP) inspections. Basilea expects the agency's inspections to be completed this year.

Separately, Basilea said it filed arbitration claims against J&J related to the pharma's handling of clinical studies for the broad spectrum anti-MRSA cephalosporin antibiotic. Basilea said its request for arbitration relates to damages suffered by the company stemming from the regulatory delay in the EU, as well as in the U.S. ...