(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)
