Polarean Imaging Shares Fall After US FDA Rejects New Drug Application
06 Octubre 2021 - 8:49AM
Noticias Dow Jones
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 ian.walker@wsj.com
(END) Dow Jones Newswires
October 06, 2021 09:34 ET (13:34 GMT)
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