Saturday, October 16

Polarean Imaging says FDA rejects new drug application, shares slump

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Polarean Imaging said on Wednesday the US Food and Drug Administration did not approve its application for a new drug-device combination product, sending its shares tumbling 60%.

The clinical-stage company, which is making a product that uses MRI technology to help diagnose lung disease, identify and monitor the treatment, said the US drug regulator had issues that were “technical or manufacturing-related in nature.”

The company said it would work on the issues identified by the FDA and that it plans to resubmit a new drug application for the product as soon as possible.

Polarean’s shares were down 57% at 44.25 pence at 1341 GMT, hitting a one-year low. (Reporting by Yadarisa Shabong in Bengaluru; Editing by Maju Samuel)

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