Company Update (NASDAQ:CEMP): Cempra Inc Announces FDA Acceptance of Solithera™ NDA to Treat Community-Acquired Bacterial Pneumonia

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, announced that its New Drug Applications (NDAs) for the approval of SolitheraTM (solithromycin) as a treatment for community-acquired bacterial pneumonia (CABP) have been accepted for filing by the U.S. Food and Drug Administration (FDA). The acceptance of the two NDAs, one for the intravenous formulation and one for oral capsules, indicates the applications are sufficiently complete to permit a substantive review by the FDA.

“The FDA’s acceptance of our two NDA filings brings us one step closer to the potential approval by the end of 2016 and U.S. commercial launch of Solithera,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “If approved, Solithera would be a significant milestone in the treatment of CABP, as bacterial resistance to older treatments has continued to rise. The FDA will convene a meeting of the Antimicrobial Drugs Advisory Committee for Solithera prior to its action on the applications.”

The NDA submissions are supported by 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 intravenous solithromycin progressing to oral solithromycin. Positive topline results were announced for both Phase 3 trials during 2015. (Original Source)

Shares of Cempra closed last Friday at $17.09, up $0.60 or 3.64%. 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 $17.70 and its 200-day moving average is $18.71.

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 128.2% 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, 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 3.1% and 8.0% respectively. Baral has a success rate of 37.5% and is ranked #830 out of 4010 analysts, while Carr has a success rate of 44.2% and is ranked #335.

The street is mostly Bullish on CEMP stock. Out of 7 analysts who cover the stock, 5 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $42.33, which implies an upside of 147.7% from current levels.

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. The company was founded by Prabhavathi B. Fernandes on November 18, 2005 and is headquartered in Chapel Hill, NC.

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