Polarean Imaging says FDA rejects fresh drug utility, shares plug

Signage is viewed outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

Oct 6 (Reuters) – Polarean Imaging (POLX.L) acknowledged on Wednesday the U.S. Food and Drug Administration did not approve its utility for a fresh drug-instrument combination product, sending its shares tumbling 60%.

The scientific-stage company, which is making a product that uses MRI know-how to relieve diagnose lung illness, title and observe the medication, acknowledged the U.S. drug regulator had disorders that had been “technical or manufacturing-linked in nature”.

The corporate acknowledged it could maybe work on the disorders identified by the FDA and that it plans to resubmit a fresh drug utility for the product as soon as seemingly.

Polarean’s shares had been down 57% at 44.25 pence at 1341 GMT, hitting a one-twelve months low.

Reporting by Yadarisa Shabong in Bengaluru; Editing by Maju Samuel

Our Standards: The Thomson Reuters Trust Principles.

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