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 that the European Medicines Agency (EMA) has validated the company’s marketing authorization application (MAA) seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP, also referred to as community-acquired pneumonia (CAP) in the EU).

The EMA’s validation of the MAA confirms that the submission is complete and formally starts the review process. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now begin their assessment of solithromycin through the centralized review procedure. If the CHMP review results in a positive opinion, the next step would be for the European Commission to grant marketing clearance for solithromycin, which would apply to all EU member states.

“With increasing failure rates of primary antibiotic therapy and increasing hospitalization rates due to CABP in the EU, there is an urgent need for new safe and effective oral and intravenous antibiotic therapies,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.

“The validation of Cempra’s MAA brings solithromycin another step closer to meeting this need in the EU and we look forward to continuing to work closely with the EMA through the review process,” Fernandes added.

If approved, solithromycin would be the first new oral and IV antibiotic available in the EU in more than 15 years. According to the European Respiratory Society (ERS), more than 3,000,000 cases of community-acquired pneumonia are diagnosed each year in the EU, resulting in approximately 1,000,000 hospitalizations annually. The ERS notes that antibiotic resistance is one of the major threats undermining the treatment of respiratory infections.(Original Source)

Shares of Cempra closed yesterday at $22.64, up $0.01 or 0.04%. 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 $20.11 and its 200-day moving average is $18.02.

On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on August 2, Morgan Stanley analyst Andrew Berens reiterated a Buy rating on CEMP, with a price target of $38, which represents a potential upside of 67.8% from where the stock is currently trading. 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, Andrew Berens and Alan Carr have a total average return of 2.2% and 11.2% respectively. Berens has a success rate of 44.6% and is ranked #1648 out of 4122 analysts, while Carr has a success rate of 48.4% and is ranked #200.

The street is mostly Bullish on CEMP stock. Out of 9 analysts who cover the stock, 8 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $40.00, which represents a potential upside of 76.7% from where the stock is currently trading.

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.