Motif Bio Delays Iclaprim New Drug Application, Shares Fall

20th Mar 2018 11:08

LONDON (Alliance News) - Motif Bio PLC's shares fell on Tuesday as the biopharmaceutical company said it has pushed back the date for its new drug application submission for iclaprim.

Motif Bio shares were down 7.0% on Tuesday morning at 33.08 pence each.

Motif Bio now expects to submit the application to the US Food & Drug Administration in the second quarter of 2018, having previously expected to do so in the first quarter.

The reason for the delay, it said, is to "ensure a complete and high quality submission".

Iclaprim is an antibiotic proposed for the treatment of acute bacterial skin and skin structure infections.

Chief Executive Graham Lumsden commented: "There are many components that go into an NDA submission and our aggressive timeline was contingent upon all outstanding items being completed to provide sufficient time to quality check and then publish the document.

"Most components are complete, but given the importance of the submission, we made the decision that it was in the best interests of the company and all stakeholders to allow more time to ensure we submit the strongest possible application."

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