Medivir delays start of Phase III remetinostat study amid FDA discussions

19 June 2018

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.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK