Polarean Imaging says FDA rejects new drug application, shares slump

Reuters
·1 min read
FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

(Reuters) - Polarean Imaging said on Wednesday the U.S. 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 U.S. 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)