Translate Bio Shares Gain After FDA Grants Rare Pediatric Disease Designation

By Chris Wack

Translate Bio Inc. shares were up 12% to $11.50 after the company said the U.S. Food and Drug Administration has granted rare pediatric disease designation for MRT5005 for the treatment of cystic fibrosis.

MRT5005 is designed to deliver mRNA encoding fully functional cystic fibrosis transmembrane conductance regulator protein to cells in the lung through nebulization.

The therapeutics company said it anticipates Covid-19-related interruptions in enrollment, dosing and follow-up in the ongoing phase 1/2 clinical trial in patients with cystic fibrosis. The company will provide updated timing on the expected interim data readout of the additional single-ascending dose group and the multiple-ascending dose portion of the clinical trial at a later date.

TranslateBio also said it was working with French pharmaceutical company Sanofi SA to develop a new mRNA vaccine candidate against Covid-19, the disease caused by the new coronavirus.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

March 27, 2020 07:49 ET (11:49 GMT)

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