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Motif Bio surges as US FDA agrees to a meeting to discuss new drug application for novel antibiotic iclaprim

The AIM-listed firm said the meeting with the US watchdog is scheduled to take place on May 3, 2019, with official meeting minutes typically received from the FDA within 30 days of a meeting
Antibiotics
Motif Bio boss Graham Lumsden said: “We look forward to a collaborative meeting and to discussing with the Agency the best way to move iclaprim towards marketing approval"

Motif Bio PLC (LON:MTFB) (NASDAQ:MTFB), saw its shares surge on Wednesday after the biopharmaceutical company said the US Food & Drug Administration (FDA) has agreed to a meeting to discuss its need for additional data related to the new drug application for Motif’s novel antibiotic, iclaprim

The AIM-listed firm said the meeting with the US watchdog is scheduled to take place on 3 May 2019, with official meeting minutes typically received from the FDA within 30 days of a meeting. 

READ: Motif Bio seeks talks with FDA after iclaprim setback

After this, Motif Bio said it will be in a position to provide an update to the market on the path forward for iclaprim, which has been developed for the treatment of acute bacterial skin and skin structure infections.

Graham Lumsden, Motif Bio’s chief executive officer said:  "We are pleased that the FDA has granted our meeting request and that critical personnel from the FDA have been invited to attend the upcoming meeting with our internal and external experts.

“We look forward to a collaborative meeting and to discussing with the Agency the best way to move iclaprim towards marketing approval."

Financing

As previously announced, the company also reaffirmed that it needs to raise additional capital in the near term, with a further update regarding financing to be made in due course.

In early afternoon trading in London, Motif Bio shares were 52% higher at 9.00p.

The company said on 14 February that it had requested a meeting after the FDA said it wouldn’t be giving the regulatory green light to the company’s antibiotic, iclaprim.

In what is called a complete response letter, the FDA indicated additional data would be required “to further evaluate the risk for liver toxicity” before granting approval.

 -- Updates share price --

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Motif Bio PLC Timeline

Newswire
May 07 2019

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