Shares of US biotech firm Sesen Bio (Nasdaq: SESN) plunged nearly 32% to $0.62 yesterday, after it announced that it has made the strategic decision to voluntarily pause further development in the USA of its lead asset, Vicineum (oportuzumab monatox-qqrs).
The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase III clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC), following recent discussions with the US Food & Drug Administration (FDA).
Last year, Sesen, previously known as Eleven Biotherapeutics, announced that it received a Complete Response Letter (CRL) from the US FDA on its Biologics License Application (BLA) for Vicineum for the treatment of NMIBC.
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.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze