Merck & Co (NYSE: MRK) today announced that the US Food and Drug Administration has accepted for review a supplemental Biologics License Application (sBLA) for its dual immuno-oncological/chemotherapeutic treatment candidate.
The announcement, which was made at close of trading on the New York Stock Exchange, caused shares in the American pharma giant to rise significantly in the pre-market period, to $61.70 (+3%).
Rather than wait for Phase III trial data to support its application, Merck has chosen to utilize the FDA’s Accelerated Approval program in a more high risk, first-to-market strategy.
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