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 completion of its submission of the MAA for solithromycin to the European Medicines Agency (EMA) for the treatment of community-acquired bacterial pneumonia (CABP). The MAA is for the intravenous and oral capsule formulations.
“The submission of this application to the EMA represents an important achievement in Cempra’s effort to bring a potentially important new antibiotic treatment option to critically ill patients in the EU with CABP, where it could help to offset the rising problem of bacterial resistance,” stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “We look forward to working with the EMA in the coming months with the goal of bringing this potent intravenous and oral treatment to patients in need.”
The recent referendum vote in the UK to leave the EU over the next two years is not expected to affect the review of our submission.
This submission in Europe follows the completed submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration in late April this year. Both regulatory submissions include safety and efficacy data from two Phase 3 studies of solithromycin in the treatment of CABP. The first study was a pivotal Phase 3 clinical trial of solithromycin oral capsules, and the second was a global, pivotal Phase 3 clinical trial of IV solithromycin progressing to oral solithromycin. Positive topline results were announced for both Phase 3 trials during 2015.(Original Source)
Shares of Cempra closed yesterday at $16.05, down $1.36 or -7.81%. CEMP has a 1-year high of $46.99 and a 1-year low of $14.03. The stock’s 50-day moving average is $17.48 and its 200-day moving average is $19.16.
On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on June 24, Cowen analyst Ritu Baral reiterated a Buy rating on CEMP, with a price target of $39, which implies an upside of 143.0% from current levels. Separately, on the same day, Needham’s Alan Carr reiterated a Buy rating on the stock and has a price target of $48.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ritu Baral and Alan Carr have a total average return of -0.4% and 6.2% respectively. Baral has a success rate of 31.7% and is ranked #2582 out of 3967 analysts, while Carr has a success rate of 40% and is ranked #415.
Overall, 2 research analysts have assigned a Hold rating and 5 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 $44.00 which is 174.1% above where the stock closed yesterday.
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.