cempra inc (CEMP) Key Developments
Cempra, Inc. Presents at 2nd Annual ROTH Healthcare Day, Jun-24-2015
May 27 15
Cempra, Inc. Presents at 2nd Annual ROTH Healthcare Day, Jun-24-2015 . Venue: The Dorchester, 53 Park Lane, Mayfair, London, W1K 1QA, UK, United Kingdom.
Cempra, Inc. Presents at Jefferies 2015 Global Healthcare Conference, Jun-02-2015 10:00 AM
May 26 15
Cempra, Inc. Presents at Jefferies 2015 Global Healthcare Conference, Jun-02-2015 10:00 AM. Venue: The Grand Hyatt Hotel, New York, New York, United States. Speakers: Prabhavathi B. Fernandes, Founder, Chief Executive Officer, President and Director.
Cempra, Inc. Presents Results from Its Phase 3 Clinical Trial
May 19 15
Cempra, Inc. is presenting results from its Phase 3 clinical trial demonstrating the statistical non-inferiority of oral solithromycin versus oral moxifloxacin for the treatment of community acquired bacterial pneumonia (CABP). Oral solithromycin demonstrated statistical non-inferiority to oral moxifloxacin for the treatment of CABP and the solithromycin early clinical response (ECR) and short term follow-up (SFU) rates were numerically higher than moxifloxacin in the elderly, the patients at greater risk for CABP. Solithromycin was non-inferior to moxifloxacin on every pre-specified outcome measure in the study. The study consisted of a 1:1 randomization of 860 CABP patients to oral solithromycin for 5 days or oral moxifloxacin for 7 days, stratified by geographic region, by history of asthma and/or chronic obstructive pulmonary disease (COPD), and by PORT score (II vs. III/IV). PORT II severity pneumonia was capped in the study at 50%. The primary endpoint (for FDA) was non-inferiority (NI) in ECR rate at 72 hours in the intent-to-treat (ITT) population. The primary endpoint (for EMA) was NI in success rate at SFU visit, 5 to 10 days after end of therapy in the ITT and clinically-evaluable (CE) populations. Patients randomized to solithromycin received an 800 mg loading dose on day 1, 400 mg on days 2-5 and placebo on days 6 and 7. Patients in the moxifloxacin treatment arm received 400 mg on days 1-7. Oral solithromycin demonstrated statistical non-inferiority to oral moxifloxacin for the treatment of CABP with a treatment success rate in the ECR-ITT population of 78.2% for solithromycin and 77.9% for moxifloxacin. The 95% confidence interval for the treatment difference had lower and upper bounds of -5.5% and 6.1%, respectively. Notably, solithromycin ECR rates were numerically higher than moxifloxacin in patients over 75 years of age with a treatment success rate of 83.9% for solithromycin and 69.8% for moxifloxacin. The 95% confidence interval for the treatment success rate in this age group had lower and upper bounds of -2.1 and 30.2, respectively. In addition, oral solithromycin demonstrated NI for the SFU-ITT endpoint with a success rate of 84.5% for solithromycin and 86.6% for moxifloxacin with a 95% confidence interval for the treatment difference at lower and upper bounds of -7.1 and 2.8, respectively. Treatment emergent adverse events were comparable for the two patient groups with 155 (36.6%) reported for solithromycin and 154 (35.6%) for moxifloxacin. There were no serious adverse events attributed to solithromycin. There were more Grade 4 ALT elevations among patients who received moxifloxacin (1.2%) compared to solithromycin (0.5%). In addition, there were two cases of C. difficile infection, both of which occurred in the moxifloxacin group.
Cempra, Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015
Apr 30 15
Cempra, Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported a net loss of $17.4 million, or $0.41 per basic and diluted share, compared to a net loss of $17.0 million, or $0.51 per basic and diluted share, for the same period in 2014. Revenues were $13,963,000 compared to $3,083,000 a year ago. Loss from operations was $16,804,000 compared to $16,490,000 for the same period last year.
Cempra, Inc. to Report Q1, 2015 Results on Apr 30, 2015
Apr 23 15
Cempra, Inc. announced that they will report Q1, 2015 results at 5:00 PM, Eastern Standard Time on Apr 30, 2015