BioCentury | Feb 15, 2019
Clinical News

Complete response letter for Motif's antibiotic

FDA issued a complete response letter to an NDA for iclaprim (MTF-100) from Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) to treat acute bacterial skin and skin structure infections (ABSSSIs). Motif said FDA indicated additional liver toxicity...
BioCentury | Jan 5, 2019
Finance

Ready to launch

The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record year...
BioCentury | Aug 17, 2018
Clinical News

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019....
BioCentury | Aug 14, 2018
Company News

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019....
BioCentury | Apr 6, 2018
Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
BioCentury | Mar 23, 2018
Clinical News

Motif delays NDA for iclaprim in ABSSSIs

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said it will delay submitting its NDA for iclaprim (MTF-100) to FDA until next quarter. The company had hoped to submit the NDA this quarter seeking the antibiotic's approval to...
BioCentury | Mar 20, 2018
Company News

Motif delays NDA for iclaprim in ABSSSIs

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said it will delay submitting its NDA for iclaprim (MTF-100) to FDA until next quarter. The company had hoped to submit the NDA this quarter seeking the antibiotic's approval to...
BioCentury | Oct 6, 2017
Clinical News

Motif's iclaprim meets in second Phase III for ABSSSIs

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) reported top-line data showing that iclaprim (MTF-100) met the primary endpoint of non-inferiority to vancomycin in the Phase III REVIVE-2 trial to treat acute bacterial skin and skin structure infections...
BioCentury | Oct 4, 2017
Clinical News

Motif eyes NDA after second Phase III ABSSSI readout

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) gained 7.75p (21%) to 44.5p in London on Wednesday and rose $1.60 (16%) to $11.75 on NASDAQ after reporting that iclaprim ( MTF-100 ) met the primary endpoint of non-inferiority to vancomycin...
BioCentury | Apr 27, 2017
Clinical News

Iclaprim: Ph III REVIVE-1 data

Top-line data from the double-blind, international Phase III REVIVE-1 trial in 598 patients with ABSSSIs showed that 80 mg IV iclaprim every 12 hours for 5-14 days met the primary endpoint of non-inferiority to vancomycin...
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