Polarean Imaging Shares Fall After US FDA Rejects New Drug Application

By Ian Walker

Shares of Polarean Imaging PLC fell as much as 49% on Wednesday after the company said that the U.S. Food and Drug Administration has rejected its new drug application for a drug-device combination product.

The company --which is developing a product to enhance magnetic resonance imaging in pulmonary medicine-- said that the FDA has provided a list of issues that need to be addressed, most of which are technical or manufacturing related and centre around the Xenon hyperpolariser system.

Shares at 1313 GMT were down 47.0 pence, or 45%, at 57.0 pence after falling to a low of 53.0 pence shortly after the announcement was made.

Polarean said that it will work to address these issues and resubmit a new drug application as soon as possible. Following resubmission the FDA review is expected to take two to six months.

The company said that it had $38.2 million of cash at June 30 so it can fund operations comfortably through this review period.

"We are obviously disappointed that we haven't received FDA approval within this review cycle, and we will continue to work diligently with the FDA to understand their recommendations to address the issues that have led to the CRL [complete response letter] being issued," Chief Executive Richard Hullihen said.

He added that the board is confident in the safety and efficacy profile of hyperpolarised noble gas imaging and the company's ability to accomplish its goals.

Write to Ian Walker at [e-mail]

(END) Dow Jones Newswires

October 06, 2021 09:34 ET (13:34 GMT)

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