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US FDA to make decision on Shield Therapeutics’ Feraccru drug by end of July

Last updated: 14:15 13 Dec 2018 GMT, First published: 07:24 13 Dec 2018 GMT

blood cells
Feraccru is designed to boost haemoglobin levels

US regulators have confirmed they will make a decision on whether or not to approve Shield Therapeutics PLC’s (LON:STX) Feraccru drug by 27 July 2019.

Feraccru is Shield’s flagship drug which has already been approved in Europe as a treatment for iron deficiency in adults.

READ: Shield’s Feraccru to be considered for US market

The US makes up a third of the global pharmaceutical market, so should the Food and Drug Administration (FDA) give the green light, it would open up a “highly attractive” and potentially lucrative opportunity.

Chief executive Carl Sterritt said: “Confirmation of the PDUFA date for completion of the review of Feraccru by the FDA is another important step towards being able to offer Feraccru to the very large pool of iron-deficient patients in the United States who would benefit from this novel new treatment option.”

“We will continue to work closely with the FDA to achieve this goal, whilst also seeking an attractive commercial partner for Feraccru in the USA who can help us realise the full value of the opportunity that would be created by Feraccru's approval.”

In a note to clients, analysts at ‘house’ broker Peel Hunt, commented: “At its interim report for its 6 months to 30 June 2018, Shield had suggested an FDA approval decision would be made during Q4 2019 and as such the 27 July 2019 PDUFA date represents a beat vs those timing expectations.

“As we published in our recent report, we see 85p/sh upside in addition to our 70p if Ferracru gets FDA approval in the US. We see today’s news as supportive of the stock, we maintain our Buy recommendation and 70p TP.”

In afternoon trading, shares in Shield Therapeutics were 1.6% higher at 31.50p.

 -- Adds analyst comment, share price --

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