Shield Therapeutics (STX); FDA approves Feraccru with a broad label

Published on 26-07-2019 07:17:06
Author Daniel Wilkinson

The FDA has approved Shield Therapuetics’ lead asset Ferraccru, for the treatment of iron deficiency in adults. The FDA has granted the broadest label possible which means adults with iron deficiency of any underlying cause can be prescribed Ferraccru (to be marketed as Accrufer in the US). This is upside to our previous assumptions where we had assumed a narrower label and enables a larger commercial opportunity. Shield is in discussion with a number of potential commercial partners in the US who will market Accrufer on its behalf. This is hugely positive.

Shield is revenue generating through its partner Norgine in Europe and so the FDA approval removes all regulatory risk. The broad label from the FDA underpins its belief in all trials to date and should enable better partnering economics. Feraccru is a great product compared to Intravenous Iron and health economics based pricing could see it garner decent market share. Further upside could come also from other studies such as in woman’s health

Author:Dr Daniel Wilkinson

Share this with friends and colleagues