Karyopharm Shares Climb Following European Commission's Marketing Authorisation For Multiple Myeloma Candidate

The European Commission (EC) has granted Marketing Authorisation for Karyopharm Therapeutics’ KPTI lead candidate NEXPOVIO (selinexor) in combination with once-weekly bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received at least one prior therapy.

The regulatory approval followed the positive opinion granted in May 2022 by The Committee for Medicinal Products for Human Use (CHMP ) based on results from the Phase 3 BOSTON study.

The conditional marketing authorisation for NEXPOVIO is now converted to a full approval, with this extended indication in the European Union (EU).

Richard Paulson, President and Chief Executive Officer, said, "The European Commission's approval of an expanded use of NEXPOVIO® provides another option for patients with multiple myeloma who have relapsed, or become resistant to current treatment regimens. Our decision to pursue approval for this patient population is indicative of our commitment to expand access to selinexor across the globe and we look forward to working closely with Menarini who will commercialize NEXPOVIO in Europe."

This marketing authorisation marks the second indication for NEXPOVIO, is valid in all 27 member states of the European Union as well as Iceland, Liechtenstein, Norway, and Northern Ireland.

Price Action : Karyopharm shares are trading around 9 percent higher at $5.22 on Thursday during pre-market session.