Cempra Inc (NASDAQ:CEMP) announced that the company has withdrawn its marketing authorization application (MAA) seeking European Medicines Agency (EMA) approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired pneumonia in adults.
Based on the Day 120 questions Cempra received from the EMA, the company believes additional data would be required. By withdrawing the MAA at this time, Cempra will conserve considerable financial resources, and it will allow the company to align its strategy to provide additional data to both the EMA and U.S. Food and Drug Administration (FDA) to support potential approval.
“Our goal is to make solithromycin available in the EU to address an important unmet medical need. We believe the most efficient path to approval is to withdraw the MAA at this time and to resubmit it with the additional data requested by the FDA,” said David Zaccardelli, Pharm.D., acting chief executive officer of Cempra.
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.
Shares of Cempra are currently trading at $4.11, down $0.24 or -5.63%. CEMP has a 1-year high of $26.95 and a 1-year low of $2.55. The stock’s 50-day moving average is $3.58 and its 200-day moving average is $9.85.
On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on March 1, Janney analyst Debjit Chattopadhyay maintained a Hold rating on CEMP, with a price target of $5.00, which represents a potential upside of 15% from where the stock is currently trading. Separately, on the same day, Needham’s Alan Carr reiterated a Hold rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Debjit Chattopadhyay and Alan Carr have a yearly average loss of -1.4% and a return of 11% respectively. Chattopadhyay has a success rate of 44% and is ranked #3704 out of 4555 analysts, while Carr has a success rate of 46% and is ranked #348.
Overall, one research analyst has rated the stock with a Sell rating, 9 research analysts have assigned a Hold rating and 2 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 $2.25 which is -48.3% under 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 products include; Solithromycin and Taksta.