Medivir delays start of Phase III remetinostat study amid FDA discussions

Shares of Sweden-based Medivir (OMX: MVIR) fellow 12% after the company said it has decided to continue the discussions with the US Food and Drug Administration to agree on the design of the planned pivotal Phase III clinical study of its lead compound remetinostat for the treatment of early-stage cutaneous T-cell lymphoma (CTCL).

The aim of the continued dialog with the FDA is to agree upon the design for a Phase III study that could, if successfully completed, lead to the approval of the company's most advanced candidate drug within oncology. The start of the study will not be possible earlier than 2019, and thus not in 2018 as previously communicated.

"We firmly believe that remetinostat has an important role in the treatment of various cancers, including early-stage cutaneous T-cell lymphoma, where there is a great unmet medical need," commented Christine Lind, chief executive of Medivir.