Company Update (NASDAQ:CEMP): Cempra Inc’s Pivotal Phase 3 SOLITAIRE-IV Study of IV to Oral Solithromycin Published in Clinical Infectious Diseases

Cempra, Inc. (NASDAQ:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the publication of its pivotal Phase 3 study, SOLITAIRE-IV, comparing the efficacy and safety of intravenous-to-oral solithromycin to intravenous-to-oral moxifloxacin for the treatment of community-acquired bacterial pneumonia (CABP) in Clinical Infectious Diseases.

As previously reported, the SOLITAIRE-IV study demonstrated that solithromycin was non-inferior to moxifloxacin, a potent respiratory fluoroquinolone, for treatment of CABP, meeting its primary endpoint that was aligned with FDA guidance.

Cempra’s other pivotal Phase 3 study with solithromycin, SOLITAIRE-ORAL, which evaluated the efficacy and safety of oral solithromycin versus oral moxifloxacin for the treatment of CABP, also met its primary non-inferiority endpoint and was published in Lancet Infectious Diseases in February 2016.

“The SOLITAIRE-IV study highlights the potential for physicians to transition CABP patients from IV to oral solithromycin, without needing to add or change drug classes. This type of approach could have significant clinical and public health benefits,” said Thomas M. File, M.D., from Northeast Ohio Medical University and lead author of the study.

“If approved, solithromycin may help address the urgent problem of antibiotic resistance and provide physicians with a new, potent macrolide monotherapy option that currently does not exist when treating patients with CABP,” File added.

According to the U.S. Centers for Disease Control and Prevention (CDC), CABP is the leading cause of death due to infectious disease in the United States, killing more than 53,000 people annually. Streptococcus pneumoniae (S. pneumoniae) is the leading cause of bacterial pneumonia in the U.S.and drug-resistant S. pneumoniae is responsible for 1.2 million infections a year, according to the CDC.

“Both of Cempra’s Phase 3 pivotal trials with solithromycin met their primary endpoint and we are pleased that both studies have now been published by two of the leading infectious disease journals in the world,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.

“We believe these studies provide strong data supporting the safety and efficacy associated with solithromycin and we look forward to our ongoing interactions with regulators to achieve approval for this important new antibiotic, which could help to address the growing problem of antibiotic resistance,” Fernandes added. (Original Source)

Shares of Cempra opened today at $21.63, down $-0.60 or 2.85%. CEMP has a 1-year high of $39.25 and a 1-year low of $14.03. The stock’s 50-day moving average is $20.21 and its 200-day moving average is $18.01.

On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on August 2, Robert W. Baird analyst Brian Skorney reiterated a Buy rating on CEMP, with a price target of $33, which implies an upside of 52.6% from current levels. Separately, on the same day, Morgan Stanley’s Andrew Berens reiterated a Buy rating on the stock and has a price target of $38.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Skorney and Andrew Berens have a total average return of 6.2% and 3.1% respectively. Skorney has a success rate of 55.2% and is ranked #535 out of 4127 analysts, while Berens has a success rate of 45.5% and is ranked #1375.

Overall, one research analyst has assigned a Hold rating and 8 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $40.00 which is 84.9% above where the stock opened today.

Cempra, Inc. engages as a clinical-stage pharmaceutical company, which focuses on the development of antibacterials to meet critical medical needs. Its antibiotic candidates includs Solithromycin and Taksta. 


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