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Circassia's drug filing accepted by FDA

The US regulator has confirmed the group will have received a full response by the end of March 2019
August 13, 2018

Since gaining access to two of AstraZeneca’s (AZN) respiratory drugs in March 2017, Circassia (CIR) has delivered plenty of good news – positive clinical updates from the Astra medicines, steady commercial expansion and a sharp drop in research and development spending. And yet the share price has fallen more than a fifth since then. 

IC TIP: Buy at 77p

Most recently, the respiratory specialist – which has realigned its strategy since its major allergy trial failure in 2016 – has had its regulatory submission for Duaklir and Tudorza (the two drugs from Astra) accepted by the US Food and Drug Administration. That means it is likely to gain approval in March next year, which should boost group revenue. Broker Stifel thinks Duaklir has the potential to generate annual revenue of over $200m (£157m).